Natty Test Boosters

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    Natty Test Boosters


    Hello Doctor,

    We all know that heavy compound exercises and healthy fats help maintain test levels.My question for you is which compounds do you suggest to help boost test levels and control estrogen?There are so many options such as DAA,Divanil,Testofen,Fadogia,I-3-C,etc.

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    I agree that there are so many options on the market and probably so many so, it would make your head spin. I am uncertain I am concerned about the ingredients per se as much as I am that they are in - or as close to - study dose.

    The most imperative question is: if you boost testosterone (and a LOT of things can do this to some degree...hence the fact that lab work is great to see, but without concomitant ergogenic data, it means very little as to why people use the substances in the first place); will it necessarily impact body composition, strength, performance, endurance, or whatever other ergogenic benefit you seek.

    DAA is a great example - from a "natural" testosterone enhancer standpoint; it is really effective. Will it impact body comp, et al. to any precipitous degree...that remains subject for debate. Fortunately, we are doing some longer-term studies on this particular agent to reassess (see DAA thread for more).


    Ancillary products to go with DAA target prolactin inhibition if plans to use the agent longer term and/or the concucrrent use of an AI.

    To discuss the ones you mentioned in your opening statement...

    (1) Fadogia's use is limited and the product should suggest microcycles with intermittent breaks ("weekend holiday"). If used with care, it is highly androgenic, but anabolic is a subject for debate (we don't see crazy positives outside of the bedroom to beard growth...so forget it for body comp, et al...).

    (2) Testofen is not recommended due to the fact that - 1st, the only pro-testosterone data comes from the patent holder and 2nd, its actually pro-estrogenic in certain tissues.

    (3) Divanil is good and with a lot of nice data; finding a true extract that's worthwhile taking is a completely different animal. Kind of explains why it was "most effective" at 4 times per day dosing.

    (4) I3C has copious tallies of data on hormonal changes (predominate estrogen channeler); but not a lot of body comp, et al data...so incorporation of this agents is dependent on why you are employing it in the first place. If to offer assistance to estrogen control in the peri-cycle timeframe; so be it - or while using something like DAA...but otherwise, it again is subject for debate.


    Hell, I am constantly chastized for speaking modestly positive for tribulus still. But understand where I am coming from on this one...the data is there on hormonal change, libido, androgenic properties, and sperm/fertility data. Body comp data is lacking significantly so, BUT most trials were 4-8 weeks in duration (not enough time for overt MYOFIBRIL reconstruction that would be recognized in a clinically-significant manner). I was told that Patrick Arnold was not a fan and countered my argument on myofibril reconstruction saying evidence is available just DAYS after the training stimulus; and while this is, in fact, TRUE...the "evidence" is neurologic and not on a myofibril level (i.e.- myofibril hypertrophy).


    I have heard good things and seen good numbers with Triazole from DS, though I have very limited direct first-hand experience with the active ingredients individually; and again...body composition data is simply not there...just movement of lab numbers. And it is in its infancy on the market still; but I am excited for Matt Cahill and truly think he does innovation well in this industry, so I...myself, would be interested in trying this product.

    There aren't a lot of combo products I am excited about; but let me do a quick scan of nutraplanet....

    Definitely worth a try (from my scan):
    1) Athletix - Formula X (as far as Atheltix's other hormonal stuff...I am fine with Division 1 but there is no telling how much Divanil is actually in there; and the Titanium XL would be good without the darned Fenugreek)
    2) Driven Sports' Triazole (as above) and ActivaTe Xtreme are good and one might consider stacks of this with Formula X.
    3) Ruthless Supplements Phytoserms-347 looks "ok" and dosing seems to be equivocal; but I don't harbor issue with the product's development.
    4) Get Diesel Sunami,...again looks "ok" BUT I kind of wish they left out the pregnenelone
    5) APS Testalensis - may or may not be underdosed in some areas, enough to make it look interesting
    6) E-Pharm Test Force 2 and Ursobolic
    7) Purus Labs' Recycle (though quercetin is grossly underdosed, even with the piperine and the Divanil IS underdosed as well; but there's still enough to make it "interesting" to me)
    8) Brutal Alchemy Forged Steel - again "ok" by ingredient profile alone

    I am unsure what is not discontinued or what-have-you as I have not followed the industry that much in this domain; you guys may know much better than me; but as for ingredient panel...the above are not bad.


    * Natty-V from EBF has a nice ingredient profile, however, all the ingredients are under-dosed unfortunately if you look at proprietary rules.


    That may sum it up...

    Other products are "interesting" but one ingredient usually swayed me from their ingredient panel.

    Examples:
    1) Fenugreek (as above)
    2) Fulvic Acid - it robs the body of selenium, so really has no place in a formula for test-boosting and it makes Selenium dosing VERY challenging to compensate
    3) Green Tea - increases SHBG (there is mild, uncontrolled data here....but still - if increasing T is the goal; then this should probably be avoided in a product that includes Divanil or is marketed toward pro-T; I don't want more bound fraction T)
    4) Stop using saw palmetto; there are plenty of reasons not to include this in a formula for pro-T.
    5) Fadogia needs to be dosed MUCH higher than people do sometimes.


    I am gonna stop here; hopefully I have hit on what you wanted out of this thread...

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    there hascalways been debates if supps that raise T levels actually result in better performance/composition. the proponents usually argue that if your T levels are at the high end, then you should benefit from it. What would you say in a response to them? I've been on the sideline watching the debate and would like tochear your take on it.

    Also I found it interesting that you mentioned lack of research showing bosy composition change, but later you recommended Ursobolic which if not mistaken lacks research. I'm very interested in what PA says it does, but waiting to see results from e users
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    Quote Originally Posted by fadi View Post
    there hascalways been debates if supps that raise T levels actually result in better performance/composition. the proponents usually argue that if your T levels are at the high end, then you should benefit from it. What would you say in a response to them? I've been on the sideline watching the debate and would like tochear your take on it.
    Cummulative effect may be good, if at the high end (in other words, if you stay on it and/or keep test levels higher long-term - defined at about a MINIMUM of 3 months). It's like tribulus....it does something biochemically (we know it does; contrary to nay-sayers); but studies are just not long enough to see performance/composition effects that would be worthwhile talking about (see aforementioned neurologic versus myofibril discussion). Even then, one could suggest that unless it takes you supraphysiologic; it will also have minimal effect.

    I can say this...to me; I like my test levels in the upper limits of "normal" at a MINIMUM; if this is a means to get there, so be it!



    Also I found it interesting that you mentioned lack of research showing bosy composition change, but later you recommended Ursobolic which if not mistaken lacks research. I'm very interested in what PA says it does, but waiting to see results from e users
    I also recommended DAA, Mucuna, Divanil, et al... which are compounds that do what they say, but we have no translational data into ergogenesis. The product Ursobolic is translated effectively dosing wise to do "something" but we can revert to the same discussion...lagging translationally, like all "natural" test boosters.



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    Doc,

    What do you think of the ingredients in BioForge V3?

    Primavie® (Shilajit Fulvic acid complex) 200 mg ** 200 mg **
    Sensoril® (Ashwagandha extract) 150 mg ** 150 mg **
    EuryGold (Eurycoma Longifolia Standardized Extract) 300 mg ** 300 mg **
    Zinc Picolinate (Yields 6mg of Zinc) 30 mg 40% 30 mg 40%
    Cholecalciferol (Vitamin D3) 2000 IU 333% 2000 IU 333%
    Piper nigrum extract (95% Piperine) 5 mg ** 5 mg **
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    Doc,
    Again thanks for all the help.At age 45 I am looking to run a good natty non hormonal t-boost stack for the winter time.I think I will go with DAA,Triazole,and BPS's EndoSurge www.bulkperformancesolutions.c om which has both divanil and mucana pruriens in a non proprietary formula.Great info about the fulvic acid and selenium since I do take Jarrow Formula's Selenium Synergy(5on/2off).Also,I am curious to know about the tribulus dosage you would suggest and I would believe the higher the protodioscin % the better.

    I do have a second question for you.Again at age 45,I take 2000mg of pumpkinseed oil with15mg of lycopene twice a day with food for prostate health.Is this a good combo and dose?
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    "2) Fulvic Acid - it robs the body of selenium, so really has no place in a formula for test-boosting and it makes Selenium dosing VERY challenging to compensate "

    What do you think of PrimaVie? It is Shalijit which which contains 60% fulvic acid, it HITS ME GREAT. So I wonder how much can fulvic acid really be a problem to testosterone. Maybe since my multi contans selenium it does not effect me negatively?
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    As for the selenium/fulvic antagonism; we can say a few things (and I will try to respond to all questions in this thread):

    1. BioForge ingredients: It's not bad looking per se. I would add supplemental selenomethionine; BUT I am unsure how to account for the amount. See; fulvic acid when given to deficient persons is VERY antagonistic to selenium (probably some other minerals too, but selenium's the best characterized). In athletes, uncontrolled oxidation caused by exercise could promote an acutely "deficient" state that becomes VERY challenging to assess. Now, this is probably time and intensity dependent. There are a couple adaptogens like Ashwagandha (which I do like) in this, however, I do think it is a bit underdosed.

    2. PrimaVie: no different in my suggestion of selenium antagonism; but I am uncertain how you anticipate selenium deficiency to feel and this length of time on the product may not be enough time to see an effect. I am more concerned about bone mineralization and antioxidant prowess as opposed to testosterone, BUT it is noteworthy that ANYTHING that antagonizes selenium is counter-intuitive in a PRO-testosterone product. I am certain it does "hit you great" if you mean that it does make you feel better; there are plenty of adaptogenic products that do this - rhodiola is probably the best known; Ashwagandha is another (probably a reason they were coupled in BioForge product, although I am unsure). It could very well be that your multi has selenium and that is preventing "deficiency" - I have no idea as NO DATA exists on how best to accomodate for the antagonistic property and in the unique world of exercise; I am not sure one can predict it at all.



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    Quote Originally Posted by koi1214 View Post
    Doc,
    Again thanks for all the help.At age 45 I am looking to run a good natty non hormonal t-boost stack for the winter time.I think I will go with DAA,Triazole,and BPS's EndoSurge www.bulkperformancesolutions.c om which has both divanil and mucana pruriens in a non proprietary formula.
    Looks like you'd have a truly nice stack honestly. I am unsure how BPS arrived at the mucuna dose and combination they have, but - with the higher % extracts of L-Dopa...it is interesting to note that lower % extracts caused higher Testosterone surges in studies when testosterone was studied. We actually explored some of the mucuna studies in the fertility thread; although I forget exactly what was discussed.


    Also,I am curious to know about the tribulus dosage you would suggest and I would believe the higher the protodioscin % the better.
    This depends on what you are using it for. If the goal is body composition changes, we have already commented on that in this thread; I am unsure you'd be happy with use in an 8-week or less trial. But, if just looking for positive levels of androgeny (given you age); the highest % of protodioscin is a good place to start.


    I do have a second question for you.Again at age 45,I take 2000mg of pumpkinseed oil with15mg of lycopene twice a day with food for prostate health.Is this a good combo and dose?
    The postulated mechanism of action for pumpkinseed oil and the prostate centers on the high zinc concentration in the oil itself, although there is only one human study to date (and it was a combo trial with saw palmetto from 2009 unfortunately).

    There is research in rodents that pumpkinseed oil may inhibit testosterone-induced growth on the prostate gland, however, it is not clear whether pumpkinseed oil supplements would have much of an effect on overall blood testosterone levels. It's doubtful, but again - like the fulvic acid discussion before it; if testosterone elevation is our goal, should we be including it? I am unsure I can answer with 100% certainty.

    We have looked into suggestions of the "DHT hypothesis" and if you think for a moment about it...it's the older guys who get prostate pathology; but it's these older guys who have the lowest levels of teststerone (declination at a rate of about 10% per decade after age 25-35 years), which would also mean lower levels of DHT. We have found that aromatase inhibition (as opposed to 5-alpha-reductase inhibition) proves a lot stronger when treating the prostate as it is estrogen responsible for increase the concentration of DHT receptor. Remember that DHT is MUCH more potent than testosterone; if testosterone's fate is not down the amplification pathway (T --> DHT); then there is likely much more room for the diversification pathway (T --> E) - possibly compounding the problem. Compounds with AI acitivity likely have a greater benefit on prostate health itself.

    As for lycopene; there are observed decreases in Prostate Specific Antigen (PSA) values; but how this translates to the true pathology at hand is unclear.


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    Supposedly shilajit "Shilajit enhances rehabilitation of muscle, bones and nerves"
    Wouldn't that go against the action of fulvic acid?
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    Another one I came across:
    Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia

    1. T. K. Biswas1,
    2. S. Pandit1,
    3. S. Mondal1,
    4. S. K. Biswas1,
    5. U. Jana1,
    6. T. Ghosh1,
    7. P. C. Tripathi2,
    8. P. K. Debnath3,
    9. R. G. Auddy4,
    10. B. Auddy4

    Article first published online: 11 JAN 2010

    Summary

    The safety and spermatogenic activity of processed Shilajit (PS) were evaluated in oligospermic patients. Initially, 60 infertile male patients were assessed and those having total sperm counts below 20 million ml−1 semen were considered oligospermic and enrolled in the study (n = 35). PS capsule (100 mg) was administered twice daily after major meals for 90 days. Total semenogram and serum testosterone, luteinising hormone and follicle-stimulating hormone were estimated before and at the end of the treatment. Malondialdehyde (MDA), a marker for oxidative stress, content of semen and biochemical parameters for safety were also evaluated. Twenty-eight patients who completed the treatment showed significant (P < 0.001) improvement in spermia (+37.6%), total sperm count (+61.4%), motility (12.4–17.4% after different time intervals), normal sperm count (+18.9%) with concomitant decrease in pus and epithelial cell count compared with baseline value. Significant decrease of semen MDA content (−18.7%) was observed. Moreover, serum testosterone (+23.5%; P < 0.001) and FSH (+9.4%; P < 0.05) levels significantly increased. HPLC chromatogram revealed inclusion of PS constituents in semen. Unaltered hepatic and renal profiles of patients indicated that PS was safe at the given dose. The present findings provide further evidence of the spermatogenic nature of Shilajit, as attributed in Ayurvedic medicine, particularly when administered as PS.
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    Quote Originally Posted by andrew732 View Post
    Supposedly shilajit "Shilajit enhances rehabilitation of muscle, bones and nerves"
    Wouldn't that go against the action of fulvic acid?
    I am uncertain what you are referencing here. If suggestion comes from supplement informationals, I am less likely to believe that. We have selenium deficiency states in reality that approximate the model.

    http://www.ncbi.nlm.nih.gov/pmc/arti...1/?tool=pubmed



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    Quote Originally Posted by andrew732 View Post
    Another one I came across:
    Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia


    1. T. K. Biswas1,
    2. S. Pandit1,
    3. S. Mondal1,
    4. S. K. Biswas1,
    5. U. Jana1,
    6. T. Ghosh1,
    7. P. C. Tripathi2,
    8. P. K. Debnath3,
    9. R. G. Auddy4,
    10. B. Auddy4
    Article first published online: 11 JAN 2010

    Summary

    The safety and spermatogenic activity of processed Shilajit (PS) were evaluated in oligospermic patients. Initially, 60 infertile male patients were assessed and those having total sperm counts below 20 million ml−1 semen were considered oligospermic and enrolled in the study (n = 35). PS capsule (100 mg) was administered twice daily after major meals for 90 days. Total semenogram and serum testosterone, luteinising hormone and follicle-stimulating hormone were estimated before and at the end of the treatment. Malondialdehyde (MDA), a marker for oxidative stress, content of semen and biochemical parameters for safety were also evaluated. Twenty-eight patients who completed the treatment showed significant (P < 0.001) improvement in spermia (+37.6%), total sperm count (+61.4%), motility (12.4–17.4% after different time intervals), normal sperm count (+18.9%) with concomitant decrease in pus and epithelial cell count compared with baseline value. Significant decrease of semen MDA content (−18.7%) was observed. Moreover, serum testosterone (+23.5%; P < 0.001) and FSH (+9.4%; P < 0.05) levels significantly increased. HPLC chromatogram revealed inclusion of PS constituents in semen. Unaltered hepatic and renal profiles of patients indicated that PS was safe at the given dose. The present findings provide further evidence of the spermatogenic nature of Shilajit, as attributed in Ayurvedic medicine, particularly when administered as PS.
    This is actually a study that would pique my interest when it comes to selenium antagonism. Do you have the complete citation?


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    Clinical evaluation of spermatogenic activity of processed Shilajit (PS) in oligospermia Tuhin Kanti Biswas1*, Srikanta Pandit1, Samaresh Mondal1, Sunil Kumar Biswas1, Utpalendu Jana1, Tapan Ghosh1, Paresh Chandra Tripathi2, Pratip Kumar Debnath3 Runa Ghosh Auddy4 and Biswajit Auddy4 1 Research Unit, J. B. Roy State Ayurvedic Medical College and Hospital
    170-172, Raja Dinendra Street, Kolkata-700004, India
    e-mail: biswastuhin@rediffmail.com
    Telephone: +91-33-25335019, Telefax: +91-33-23371910

    2 Institute of Postgraduate Ayurvedic Education and Research at SVSP Hospital
    294/3/1, Acharya Prafulla Chandra Road, Kolkata 700 009, India
    e-mail: biswastuhin@rediffmail.com
    Telephone: +91-33-25335019, Telefax: +91-33-23371910

    3 Former Professor, Department of Kayachikitsa, J. B. Roy State Ayurvedic Medical College and Hospital, 170-172, Raja Dinendra Street, Kolkata-700004, India
    e-mail: pk_devnath@rediffmail.com


    Running title: Clinical evaluation of Shilajit in oligospermia

    Key words: Shilajit; oligospermia; testosterone, FSH, LH, Shilajit safety
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image001.gif[/IMG]
    * Corresponding author
    Summary Safety and spermatogenic activity of processed Shilajit (PS) was evaluated in oligospermic patients. Initially sixty infertile male patients were assessed and the patients having total sperm count below 20 million/ml semen were considered oligospermic and enrolled in the study (n=35). 100 mg PS capsule was administered twice daily after major meals for 90 days. Total semenogram and serum testosterone, LH and FSH were estimated before and at the end of the treatment. Malondialdehyde (MDA), marker for oxidative stress, content of semen and biochemical parameters for safety were also evaluated. Twenty-eight patients who completed the treatment showed significant (p<0.001) improvement in spermia (+37.6%), total sperm count (+61.4%), motility (12.4 to 17.4 % after different time intervals), normal sperm count (+18.9%) with concomitant decrease in pus and epithelial cell count compared to baseline value. Significant decrease of semen MDA content (-18.7%) was observed. Also, serum testosterone (+23.5%; p<0.001) and FSH (+9.4%; p<0.05) levels significantly increased. HPLC chromatogram revealed inclusion of PS constituents in semen. Unaltered hepatic and renal profile of patients indicated that PS was safe at the given dose. The present findings provide further evidence of the spermatogenic nature of Shilajit, as attributed in Ayurvedic medicine, particularly when administered as processed Shilajit. Introduction
    The art of living depends upon several factors including maintenance of heredity with healthy progeny. Healthy progeny depends upon healthy gametes from both male and female partners of conjugated life style. Current epidemiological evidence suggests that 15% of couples experience infertility in the world and half remain untreated and/or unresolved. The distribution of the main diagnostic groups for infertility due to the male is 25%; ovulation 25%; tubal 20%; unexplained cause 25% and endometriosis 5% (Templeton, 1995). Among infertile couples, 40% are primarily due to the infertility of the male partner, while in 20% of these cases it is a combination of both male and female factors associated which lead to infertility (Agarwal & Kulkarni, 2003). Out of several causes of male infertility, in clinical practice oligospermia is considered one of the most prevalent causes (Haslett et al., 2002). Literally, oligospermia means insufficient number of spermatozoa; but scientifically it means a medical symptom characterized by less than 20 million spermatozoa per ml of ejaculate (http://en.wikipedia.org/ wiki/Oligospermia, 2008). The basic patho-physiology of oligospermia is still unknown but several hypotheses are considered to be responsible for oligospermia. Follicular stimulating hormone (FSH) and leutinising hormone (LH) play an important role in spermatogenesis. LH primarily stimulates Leydig cells to secrete testosterone; testosterone and FSH are the two hormones that act directly on Sertoli cells to promote spermatogenesis. Synthesis of androgen-binding protein (ABP) is a FSH dependent process and this protein binds testosterone and dihydrotestosterone and thus provides a local androgenic pool to support gametogenesis (Pramanik, 2007). Therefore, the levels of testosterone and FSH act as marker components and deficiency of which may result in oligospermia. Partial mechanical obstruction may also result in oligospermia, which will lead to imminent surgical intervention (Berek et al., 1988). The excessive generation of reactive oxygen species (ROS) by abnormal spermatozoa and contaminating leukocytes has been defined as one of the important etiologies for male infertility. Generation and persistence of ROS in seminal fluid and sperm increase the rate of lipid peroxidation of sperm membrane which is manifested by a high MDA level (Maneesh & Jayalakshmi, 2006); a decrease in such high MDA levels of semen undeniably favors spermatogenesis. There is no known specific drug for the management of oligospermia in modern medicine. Extensive clinical research is going on in oligospermia utilizing various natural sources of plants, mineral and animal origin as mentioned in different classical traditional texts throughout the world, including Ayurveda, the Indian ancient system of medicine. Shilajit is considered one of the wonder medicines of Ayurveda, which since ancient times, has been utilized for the management of male reproductive disorders.
    Shilajit is a pale-brown to blackish-brown exudate that oozes from sedimentary rocks worldwide, largely in the Himalayas. Common people describe it from their knowledge as pahar-ki-pasina (sweat of mountains), pahar-ki-khoon (mountain blood), shilaras (rock-juice), asphalt, bitumen, etc. Shilajit is said to carry the healing power of these great mountains (David & Vasant, 2001). It is an important drug of the ancient Ayurvedic materia medica and it is to this day used extensively by Ayurvedic physicians for a variety of diseases. Early Ayurvedic writings from the Charaka Samhita (Sharma PV, 1998) describe Shilajit as a cure for all disease as well as a Rasayana (rejuvenator) that promises to increase longevity. It is composed of rock humus, rock minerals and organic substances that have been compressed by layers of rock mixed with marine organisms and microbial metabolites (Ghosal, 1994). Several toxicological studies, both acute and sub-chronic, have already been performed by various scientists with Shilajit throughout the world. Per oral LD50 was found to be >2000mg/kg (Ghosal et al, 1989; Acharya et al, 1988) and Shilajit was found to be safe at doses of 0.2g/kg and 1g/kg when used chronically (Kelginbaev et al, 1973; Anisimov et al, 1982; Fortan, 1984 and Al-Hamaidi et al, 2003).
    Traditional uses of Shilajit primarily focus on diabetes and diseases of the urinary tract, but also include edema, tumors, muscle wasting, epilepsy and even insanity. Modern indications extend to all systems of the human body with a significant number of additions in the reproductive and nervous system. Clinical research confirms many of the properties for which Shilajit has been used (Talbert, 2004). In Ayurveda, Shilajit is employed for the management of male reproductive disorder, and in particular, under the parlance of Vrsya (an aphrodisiac with special reference to spermatogenesis) (Sharma PV, 1981).
    However, in spite of its wide spectrum use as an aphrodisiac and spermatogenic activity by traditional Ayurvedic practitioners, no scientific report has so far been obtained for the spermatogenic activity of Shilajit in oligospermia in a clinical setting. The aim of the present research study is to explore the scientific evaluation of Shilajit for its spermaotogenic activity in oligospermic patients. In addition, evaluation of safety was carried out in the same Shilajit treated oligospermic patients.
    Patients and methods
    Preparation and analysis of the drug CrudeShilajit rock was procured from Indian Herbs, Saharanpur, India and voucher specimen is kept in the laboratory with specific code number SJ/01/05. The processing of Shilajit was carried out by a patented procedure (Ghosal, 2002). According to this procedure, crude Shilajit rock was pulverized and passed through a 40 mesh screen. Powdered samples were extracted with hot (60°C) water, maintaining a solid: solvent ration of 1:6, for one hour. It was filtered and the process repeated once again with the marc. The final pooled filtrate was spray dried to make fine free-flowing powder, which is dark brown in color and designated as Processed Shilajit (PS). The powder was stored in desiccators at room temperature (24±2°C). 100 mg of PS powder was formulated in hard gelatin capsules. The standardization of PS involved application of various analytical and chemical methods like HPLC, HPTLC, FT-IR, 1H-NMR, UV-Vis Spectrophotometric examination, GC-MS, ESR spectroscopy. HPLC was carried out in a WATERS (USA) HPLC system with PDA detector and isocratic mobile phase consisting of acetonitrile: ortho-phsophoric acid: water (32:1:67) with a flow rate of 0.6 ml/minute using C-18 Novapak reverse phase column attached with a guard column for separation. The injection volume was 20 μl in water. The photodiode array detector wavelength was set at 240 nm. Particle size of the Shilajit in solution was analyzed using evaporative light scattering instrument. Selection of the patient
    The clinical trial was conducted between June 2006 and January 2008 at J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata 700004, India after obtaining necessary permission from Institutional Ethics Committee (IEC) and the protocol was approved by the Scientific Review Committee (Ayurveda), Government of West Bengal. The IEC did not permit inclusion of any placebo group in the present study considering the grave nature of the disease. Patients who had a history of primary and secondary infertility for a period of 1-5 years were initially selected for the study. Thorough and relevant investigations were performed prior to inclusion and those matching inclusion and exclusion criteria were admitted to the study. Other relevant physical features were also considered. A total of 60 male patients aged between 30-45 years were initially included from the out patient department (OPD) of the same hospital. Out of a total of 60 patients, 21 patients were excluded as they could not meet up the inclusion criteria, 2 patients did not sign the consent form, and 2 patients did not start the treatment schedule. The rest 35 patients were enrolled for the treatment after obtaining consent according to the WHO-Helsinki protocol.
    Inclusion/exclusion criteria
    Eligibility was based on the following inclusion criteria: Infertile male patients aged between 30-45 years, irrespective of religion, occupation, income status, sperm count below 20 million sperm/ml, average motility <60 %, normal sperm <65% and spermia <3.0 ml not currently receiving any other treatment from outside and willingness to give written informed consent for participation in the study. The exclusion criteria were any concomitant serious disorders of vital organs, receiving or having any infertility treatment for the past 1 month and any other treatment being received simultaneously that may influence the study. Patients of male infertility suffering from azoospermia, asthenospermia, necrospermia/necrozoospermia and teratospermia/teratozoospermia were also excluded from the present study. Patients with history of mumps, measles, small pox, chicken pox, tuberculosis or injury to genitalia in last 10 years were also excluded from the study.

    Safety study
    Safety evaluation was also carried out during the same study period, in the same group of patients with the same dose of PS (100 mg BID). Additional 2 ml of blood was collected for this purpose at the beginning and at the end of 90 days of PS treatment.
    Treatment schedule
    All the patients were treated with PS 100 mg twice daily after principal meals, which were continued for 90 days to each patient. The present dose of PS (200 mg/day, p.o.) has been determined from the recommended dose of Shilajit in most of the debilitating states of health (Halpern, 2003) which was also simulating with 1/10th of LD50 dose in animals (Ghosal et al, 1989). Treatment of each patient was monitored weekly. No other treatment was advised to any patients that may influence the study. Each patient was closely observed for any adverse effects with PS. Subjects were given 15 days worth of capsules at each visit and compliance was monitored by traditional pill-count method at each follow-up visit and at the end of the study. A schematic representation of the study design is given in Figure 1.
    Observation criteria
    Semenogram is considered to be the direct method of analysis for the diagnosis and prognosis of the patients of oligospermia. This was performed by Giemsa and Leishman staining technique (Sood, 1999). Semen of each patient was collected for this purpose after a period of complete abstinence continued for not less than seven days. The features which were observed under the semenogram were the measurement of spermia, seminal pH, total sperm count (million/ml), liquefaction time (minutes), motility after 30, 60 and 120 minutes, spermatozoa morphology study (% of normal sperm), pus cells (per field), epithelia cells (per field) and RBC (per field). These were estimated on day ‘0’ and day ‘90’ interval. Hematologically, hemoglobin concentration (mg/dl), RBC (morphology), WBC (cmm), platelet count (x 105 per ml) and ESR(mm/hr) were measured following standard methodology (Briggs et al., 2003). These examinations were performed for the exclusion of any concomitant acute and chronic diseases, and were estimated at ‘0’ and ‘90’ days of treatment with the help of automated cell counter (Sysmex KX-21, Japan). In the present study, the amount of malondialdehyde (MDA) in the total semen was measured as an index of lipid peroxidation. This was determined by the thiobarbituric acid (TBA) assay (Mihara & Uchiyama, 1978). Briefly, 100 μl of reconstituted lyophilized semen was added to 400 μl phosphate buffer (100 mM, pH 7.4) and 1 ml of TBA reagent containing 0.8% TBA (Sigma, USA), 15% tri-chloro acetic acid, 25% (1M) HCl and 0.4% butylated hydroxytoluene (BHT) in distilled water. The samples were heated in a boiling water bath for 30 minutes, cooled and centrifuged at 3000 rpm for 10 minutes, and absorbance of the supernatant was measured at 532 nm. All values were expressed as nmoles MDA/mg of dry semen. In endocrinal investigations serum testosterone, LH and FSH levels were estimated on day ‘0’ and days ‘90’ of each patient to evaluate the role of the test drug on the hormonal level. These hormones were estimated using electrochemiluminescence immuno assay (ECLIA) using fully automated immunoanalyser, ELECSYS 1010 (Roche) and Beckman Coulter reagent kit (Germany). The safety aspect of PS for the management of oligospermia was assessed on the basis of different biochemical parameters. The parameters evaluated in the present study were fasting blood sugar (mg/dl), urea (mg/dl), creatinine (mg/dl), uric acid (mg/dl), total bilirubin (mg/dl), total protein (gm/dl), albumin (gm/dl), globulin (gm/dl), SGOT (U/ml), SGPT (U/ml) and alkaline phosphatase (U/L). These parameters indicate the renal and hepatotoxicity of the test substances with specificity and systemic toxicity in general. Biochemical parameters were estimated using an automated analyzer (Hitachi-902/BS-300, Japan). In the present study, chromatographic analysis of semen was carried out to assess the presence of PS bioactives in semen. This innovative investigation helped us to identify another important marker for assessment of the effect of PS in spermatogenesis. Semen samples collected from each patient at the commencement and after 90 days of PS treatment were used for this purpose. The samples were lyophilized within an hour of ejaculation and stored at -20°C. The lyophilized semen samples were dissolved in double distilled water at a concentration of 5 mg/ml, sonicated for 10 minutes followed by centrifugation for 10 minutes at 4ºC at 4000 rpm. The chemical constituents of the supernatant were analyzed by HPLC using the conditions mentioned before. The processed Shilajit (0.5 mg) was similarly dissolved in 1 ml of water (with sonication) and was analyzed by HPLC. Statistical analysis Percentage changes for measures were expressed as the difference between means of the baseline and treatment phases divided by the mean of the baseline phase multiplied by 100. Paired ‘student’s t-test’ was carried out with the initial and final values and p < 0.05 was considered statistically significant. Statistical analysis was performed using the computer statistical package SPSS/10.0 (SPSS, Chicago, IL, USA). Results Standardization of Processed Shilajit (PS) Standardized PS according to HPLC analysis (fig.2) was found to contain bioactive components like free and conjugated di-benzo-alpha-pyrones (DBPs), DBP-chromoproteins (DCPs) and fulvic acids and its equivalents within specified limits as mentioned in table 1.
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    Treatment efficacy The objective variables were estimated on the basis of semenogram, hematological parameters and endocrinological investigations. Semenogram investigation revealed that there was a significant (p<0.001) increase of spermia (37.6%), total sperm count (61.4%), reduction of pus cell (-55.5%) and epithelial cells (-81.1%). Significant (p<0.001) gradual increase of sperm motility was also observed after 30 minutes (12.4%), 60 minutes (13.2%) and 120 minutes (17.4%) interval. Percent increment in normal sperm (18.9%) was also found to be significant (p<0.001) after 90 days of treatment with PS at a dose of 100 mg BID. Significant increment (p<0.001) of hemoglobin (5.2%) after 90 days of treatment was observed indicating normal maintenance of body physiology of patients. This was supplemented with significant increase (p<0.05) of WBC (6%). The most important biochemical markers for spermatogenesis like testosterone, LH and FSH were also estimated and highly significant increase (p<0.001) of testosterone (23.5%) and significant (p<0.05) increase of FSH (9.4%) were observed (Table 3). However, no significant alteration was observed in serum LH level of the PS treated patients. Significant decrease (-18.7%, p<0.001) in semen MDA content was also observed in patients received PS treatment. HPLC analysis of semen A distinct difference in HPLC chromatogram of the semen samples was observed before and after 90 days of treatment with PS (Fig.3a & 3b). Several small peaks denoting Shilajit constituents (3-OH DBP, 3,8(OH)2DBP and its amino acyl conjugates) were incorporated in the semen after treatment. Safety
    Investigations on safety study of PS with a dose of 100 mg BID revealed that there was no alteration in any of the objective features related to any systemic toxicities like serum urea (-0.9%), uric acid (-7.5%), serum bilirubin (9.6%), total protein (-1.3%), serum globulin (-6.7%), SGPT (7.5%), SGOT (-3.5%) and alkaline phsophatase (-6.7%). Significant lowering (p<0.05) of fasting blood sugar (-6.8%) supports the hypoglycemic effect of Shilajit (Trivedi et al., 2004) and serum creatinine (-7.8%) indicates that the drug does not show any adverse effect in renal profile even in normal state (table 2). Twenty eight patients completed the present study. There was seven drop-out cases. The main reasons for study withdrawals were protocol violations, follow-up link lost, and physician’s decision (Figure 2). No treatmentemergentadverse events were reported to the doctors by any patients during treatment period.
    Case study
    In the present study four oligospermic patients informed about their fertility after 3 months of treatment with PS (100 mg BID) which has been presented as case studies.
    Case 1:TKK, 37 years, a serviceman, complained of infertility after 3 years of married life. Investigations indicated that his wife had no problems to conceive. The overall health status of the patient was good . Semenogram of the patient showed low spermia (1.5 ml), low sperm count (15.5 million/ml), presence of pus cells in semen and serum testosterone level was found to be in the lower range (4.77 ng/ml). After 3 months of treatment with PS (100 mg BID) the spermia and sperm count increased to 2.5 ml (66.7%) and 22 million/ml (41.9%) respectively. No observable pus cell was detected in semen and serum testosterone level increased to 6.53ng/ml. At the same visit he mentioned about his wife’s amenorrhoea for the previous 1 month and he confirmed the initiation of pregnancy with laboratory reports. Case 2: SS, a 30 year old farmer, complained of infertility after 5 years of married life. His wife maintained normal menstrual cycle. The patient had no history of complicated disease and possessed an overall healthy status. Semenogram of the patient showed low spermia (2.0 ml), low sperm count (17.6 million/ml), presence of pus cells and epithelial cells in semen and serum testosterone was found to be in the lower level (3.85 ng/ml). After 3 months of treatment with PS (100 mg BID) the spermia and sperm count increased to 3.0 ml and 22.5 million/ml respectively. No observable pus cell and epithelial cell was detected in semen. Serum testosterone level was increased to 4.71ng/ml. He also mentioned about the amenorrhea condition of his wife for the last two cycles and in the follow up visit he confirmed his wife’s initiation of pregnancy along with laboratory reports. Case 3: TSG, a 36 year old businessman, complained of anxiety, hyperacidity, loss of strength, diminished sexual activity and mentioned that he had no issue after 3 years of married life. The patient possessed an overall good health. Semenogram of the patient showed low sperm count (13.5 million/ml), slightly lower sperm motility (65 after 1 hour) and presence of pus cells in semen. Serum testosterone level was initially 3.59ng/ml. After 3 months of treatment with PS (100 mg BID) distinct improvement in sexual activity was informed with concomitant decrease in anxiety and impending doom. The sperm count also increased to 27.7 million/ml. No observable pus cell was detected. Serum testosterone level was increased to 4.99ng/ml. He also mentioned about the amenorrhea condition of his wife for the last one cycle and in the follow up visit he confirmed his wife’s initiation of pregnancy along with laboratory reports. Case 4:SS, a 32 year old information technology professional, communicated with the principal investigator of the present study. The patient was suffering from infertility for 3 years. The patient possessed an overall health status and had no other history of complicated disease. Semenogram of the patient showed low sperm count (19.5 million/ml), slightly lower sperm motility (60% after 1 hour) and presence of abnormal forms of sperm in high concentration (50%). Pus cells were also observed in the semen. After 3 months of treatment with PS (100 mg BID) the sperm count increased to 37.1 million/ml. Sperm motility was increased to 80% after 1 hour and normal sperm cell count increased to 60%. Only a few pus cells were detected in semen. Serum testosterone level increased from 3.80 to 5.01ng/ml. His wife conceived and this was subsequently confirmed within one week of withdrawal of treatment indicating that the pregnancy ensued during the treatment period.
    Discussion
    The male partner is considered a primary cause for infertility amongst couples and oligospermia is one of the most prevalent reasons for male infertility in clinical practice. In most of the cases, functional deformity in spermatogenesis is the major reason for oligospermia, which involves either defective mechanism of testosterone, LH and FSH secretion, or there may be excess production of reactive oxygen specimen (ROS) or both. Reactive oxygen species can have beneficial or deleterious effects on sperm cells depending on their concentration (Murawski, 2007). Under normal physiological conditions, spermatozoa produce a small amount of ROS for proper capacitation and acrosomal reaction. ROS in semen are generated mainly by neutrophils and also by abnormal spermatozoa (Griveau & Le Lannou, 1997). Excessive production of free radicals or ROS can damage sperm because their plasma membrane and cytoplasm contain a large amount of polyunsaturated fatty acids (Agarwal et al., 2003). It has already been well documented that high levels of ROS in the semen (seminal plasma + spermatozoa) induced lipid peroxidation and were negatively correlated with the quality of sperm in the semen (Alvarez & Storey, 1995). MDA content of semen acts as a major marker for lipid peroxidation. The present study clearly envisaged that PS could potentially control oxidative stress, which is reflected by lowered MDA levels and may stimulate spermatogenesis (Gomez et al., 1998; Jeong et al., 2006). This evidence is supplemented by significant increment of both testosterone and FSH, the two marker hormones that can directly induce spermatogenesis (table 3). At physiological level, testosterone did not produce any inhibition of FSH secretion, thus concomitant increase in serum levels of these hormones, observed in the present study, can promote spermatogenesis. Higher level of testosterone, in turn, inhibited LH secretion, which was also reflected in the present study. Apart from spermatogenesis, testosterone also controls the functional competence of the accessory sex organs, such as, prostate gland and seminal vesicles. Adequate seminal fluid, the secretions of seminal vesicles and prostate gland, is necessary for the survival and motility of spermatozoa. Hence, the probable reasons of the increased spermia, normal sperm count and motility in the present findings may be due the higher levels of testosterone. Spermatogenic activity of Shilajit is also reported pharmacologically in rats where the number of sperms in the epididymis and testes were significantly higher than that of the control animals. The serum testosterone level was also found to be significantly high in Shilajit treated rats. The changes of serum LH and FSH were negligible compared to that of the control animal (Jeong et al., 2006). One of the important constituents of PS is DBP; the ROS generated by sperm themselves and also by the phagocytes of the ejaculate can be put to balance or equilibrium by the reductants present in DBP-conjugates/DBPs (Ghosal, 2006). Other bioactives of PS, DCPs, fulvic acids, its equivalents, and amino acids can attenuate the deficiencies in oligospermic patients by captivating ROS and reactive nitrogen species (RNS), provide energy for sperm motility and therefore contribute to sperm health. Chromatographic analyses of semen after treatment with PS indicated inclusion of its constituents in semen. It was observed that PS in solution remains in a fine particle state with average diameter of the particle size being 954 nm. Being fine particulate state, ingredients of PS are quickly absorbed through intestinal tract and once in the systemic circulation, it can penetrate blood-brain (Kreuter, 2002) and blood-testis barrier (Kwon et al., 2008). Thus, PS constituents may be transmitted through blood-testis barrier to reach the target organelles, viz., seminiferous tubules and thereby exert their antioxidant actions. Hence, the observable effect of PS is probably due to the direct effect of its active constituents in the spermatogenesis process. The role of infection in male infertility is being increasingly recognized in the modern world. The decreased level of pus cells and epithelial cells after Shilajit treatment indicated that Shilajit had inhibited the growth of genital bacteria which are generally resistant to a number of currently recommended antibiotics. In literature, Shilajit has been recommended for genitor-urinary diseases (Schepetkin et al., 2002). Conclusion
    The present findings, based on advanced diagnostic and clinical methodologies, support preclinical evidence about the effective medical management of oligospermia with Processed Shilajit (PS). Also, PS can be used therapeutically at a dose of 100 mg BID without any adverse side-effects. HPLC analysis indicated that PS treatment for 90 days caused incorporation of some of its major constituents in semen. As clinical findings indicated a distinct improvement in the quality of semen of the treated oligospermic patients, it can be assumed that these improvements were partly due to inclusion of PS constituents in the semen. Regaining of fertility in four PS treated patients opens a window in the treatment of oligospermia with natural products. However, the exact role of these components on testicular function is yet to be established. This trend is expected to be more indicative if the PS treatment is continued for a longer period of time. Acknowledgement
    We acknowledge with thanks the suggestions and valuable comments of Prof. Shibnath Ghosal, former honorary advisor, Natreon Inc., Kolkata. Authors are indebted to Prof. Arup Mukherjee, Dept. of Pharmaceutical Technology, University of Calcutta, for estimation of particle size of Shilajit constituents. We also thank Natreon Inc, 2D Janine Place, New Brunswick, NJ 08901, USA for financial support to carry out the study.


    References
    Acharya SB, Fortan MH, Goel RK, Tripathi SK, Das PK (1988) Pharmacological actions of Shilajit. Ind J of Exp Biol 26(10): 775-777. Agarwal HSK, Kulkarni KS (2003) Efficacy and safety of speman in patients with
    oligospermia: an open clinical study. IndIan J Clinical Practice 14
    (2): 29-31. Agarwal A, Saleh RA, Bedaiwy MA. Role of reactive oxygen species in the
    pathophysiology of human reproduction. Fertil Steril 2003; 79: 829-43. Al-Hamaidi AR, Umar M (2003) Safe use of Shilajit during pregnancy of female mice . Online Journal of Biological Science 3(8):681- 684. Anisimov VE, Shakirzyanova RM (1982) Application of Mumie in therapeutic practice. Kazan Med J 63: 65-68. Alvarez JG, Storey BT. Differential incorporation of fatty acids into and peroxidative loss of fatty acids from phospholipids of human spermatozoa. Mol Reprod Dev 1995; 42:334-46. Berek JS, Adashi EY, Hillard PA (1988) Novak’s Gynecology. Baltimore: Williams and Wilkins; 933. Briggs C, Kunka S, Pennaneach C, Forbes L, Machin SJ (2003) Performance evaluation of a new compact hematology analyzer, the Sysmex, POCH-1001. Laboratory hematology 9(4): 225-33. David F and Vasant L (2001) The Yoga of Herbs. Twin Lakes, WI. Lotus Press; 250. Fortan MH, Acharya SB (1984) Pharmacological studies of Shilajit. Indian J Parmacol 16, 45. Ghosal, S. Lal J, Sing SK Dasgupta G Bhaduri J, Mukhopadhyay M and Bhattacharya,S.K (1989) Mast cell protecting effects of shilajit and its constituents. Phytotherapy Res 3: 249-252. Ghosal S (1994) The aroma principles of Gomutra and Karpuragandha Shilajit. Indian J. Indg.Med 11(1): 11-14. Ghosal S (2002) Process for preparing purified Shilajit, composition from native
    Shilajit, US Patent: 6,440,436, 1-14. Ghosal, S (2006) Shilajit in Perspective. New Delhi: Narosa Publishing House 132-56. Gomez E, Irvine DS, Aitken RJ (1998) Evaluation of a spectrophotometric assay for the measurement of malondialdehyde and 4-hydroxyalkenals in human spermatozoa: relationships with semen quality and sperm function. Int J Androl 21: 81-94. Griveau JF and Le Lannou D (1997) Reactive oxygen species and human spermatozoa: Physiology and pathology. Int J Androl 20: 61-9. Halpern M (2003) Principles of Ayurvedic Medicine. 5th edition. Grass Valley, CA: California College of Ayurveda. Haslett C, Chilvers ER, Boon NA, Colledge NA (Eds.) (2002) Davidson’s Principles and Practice of Medicine. Edinburgh: Churchill Livingstone, 711. Jeong SP, Gee YK, Kun H (2006) The spermatogenic and ovogenic effects of chronically administered Shilajit to rats. J Ethnopharmacol 107: 349-53. Kelginbaev NS, Sorokina VA, Stefandu AC, Ismailova VN (1973) Treatment of long tubular bone fractures with Mumie and preparation in experimental and clinical conditions. Exp Surg Anesthes 18, 31-35. Kreuter J, Shamenkov D, Petrov V, Ramge P, Cychutek K, Koch-brandt C, Alyautdin R (2002) Apolipoprotein-mediated transport of nanoparticle-bound drugs across the blood-brain barrier. J Drug Targetting 10:317. Kwon JT, Hwang SK, Hua J, Kim DS, Tehrani AM, Yoon HJ, Choi M, Yoon TJ, Han DY, Kang YW, Yoon B, Lee JK, Cho MH (2008) Body distribution of inhaled fluorescent magnetic nanoparticles in the mice. J Occup Health 50:1-6. Maneesh M, Jayalakshmi H (2006) Role of reactive oxygen species and antioxidants on pathophysiology of male reproduction. Ind J Clin Biochem
    21 (2): 80-9. Mihara H and Uchiyama M (1978) Determination of malondialdehyde precursor in tissues by thiobarbituric acid test. Anal Biochem 1: 271-78. Murawski M., Saczko J., Marcinkowska A., Chwikowska A, Grybooe M., Banaoe T (2007) Evaluation of superoxide dismutase activity and its impact on semen quality parameters of infertile men, Follia Histochemica Et Cytobiologica 45 (1) :123-26. Oligospermia, from Wikipedia, the free encyclopedia, http://en.wikipedia.org/
    wiki/Oligospermia. Accession date: June 2, 2008. Pramanik D (2007) Principles of Physiology. Kolkata, Academic Publishers
    370-4. Sharma PV (1998). Charaka Samhita. Chowkhambha Orientalia Chikitsasthana, Varanasi, Karaprchitiya RasayanaPada, 4th edition, vol 2, verse no.49-50. Sood, R (1999) Medical Laboratory technology: Methods and interpretation. New Delhi, JP Brothers. Schepetkin I, Khlebnikov A, Kwon BS (2002) Medical Drugs from Humus Matter: Focus on mumie. Drug Development Research 57:140-159. Talbert R (2004) Shilajit: A Materia Medica Monograph, A paper submitted in partial fulfillment of the requirements for the degree of Clinical Ayurvedic Specialist at California College of Ayurveda, 1117A East Main Street, Grass Valley, California. Templeton A (1995) Infertility-epidemiology, aetiology and effective management. Health Bull (Edinb) 53(5): 294-8.
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    Legends of Figures
    Fig. 1. Schematics of study design Fig. 2. HPLC chromatogram of processed Shilajit by RP-C18 column Fig. 3a. HPLC analysis of semen on day 0. Fig. 3b. HPLC analysis of semen after 90 day treatment with processed Shilajit Table 1. Bioactive constituents with specified limits of processed Shilajit [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image001.gif[/IMG]Bioactive constituents Specification Actual content (%; w/w) (%; w/w) [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image002.gif[/IMG]
    Free and conjugated ³ 0.30 0.45 di-benzo-alpha-pyrones (DBPs) DBP-chromoproteins (DCPs) ³ 10.00 16.75 Fulvic acids and its equivalents ³ 50.00 54.80 [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image001.gif[/IMG]
    Table 2: Safety parameters at baseline and after 90 days of treatment with
    processed Shilajit (100mg BID)in oligospermic patients (n=28)
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image003.gif[/IMG]

    Parameters Processed Shilajit (100 mg BID)
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image004.gif[/IMG]
    Baseline 90 days % change
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image005.gif[/IMG]
    FBS (mg/dl) 95.6 (9.7) 89.1 (7.4) -6.8
    Urea (mg/dl) 21.1 (5.0) 20.9 (3.8) -0.9
    Uric acid (mg/dl) 5.3 (1.4) 4.9 (1.5) -7.5
    Creatinin (mg/dl) 0.90 (0.14) 0.83 (0.11) -7.8
    Total bilirubin (mg/dl) 1.04 (0.33) 1.14 (0.39) 9.6
    Total protein (gm/dl) 7.6 (0.6) 7.5 (0.4) -1.3
    Albumin (gm/dl) 4.7 (0.4) 4.7 (0.3) NC
    Globulin (gm/dl) 3.0 (0.6) 2.8 (0.4) -6.7
    SGPT (U/ml) 36.1 (14.2) 38.8 (15.1) 7.5
    SGOT (U/ml) 34.1 (10.5) 32.9 (8.5) -3.5
    Alkaline phosphatase (U/L) 129.8 (42.7) 121.1 (41.0) -6.7
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image003.gif[/IMG]
    Values represent Mean (SD); indicates p<0.05.















    Table 3. Objective variables at baseline and after 90 days of treatment with
    processed Shilajit 100 mg BID)in oligospermic patients (n = 28)
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image006.gif[/IMG]

    Parameters Processed Shilajit (100 mg BID)
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image007.gif[/IMG]
    Baseline 90 days % change
    [IMG]file:///C:/Users/Enid/AppData/Local/Temp/msohtmlclip1/01/clip_image008.gif[/IMG]
    Semenogram
    Spermia (ml) 2.13 (0.72) 2.93 (0.94) 37.6*
    pH 7.90 (0.22) 8.00 (0.22) 1.27
    Total sperm count 10.60 (4.34) 17.11(8.97) 61.4*
    (million/ml)
    Liquefaction time (min) 38.71 (19.35) 39.33 (11.73) 1.60
    Motility
    After 30 min 64.07 (20.1) 72.03 (22.7) 12.4*
    After 60 min 59.64 (20.1) 67.53 (21.8) 13.2*
    After 120 min 51.36 (19.1) 60.32 (20.1) 17.4*
    Morphology 62.79 (14.2) 74.68 (6.4) 18.9 *
    (% of normal sperm)
    Pus cells (per field) 5.46 (3.2) 2.43 (2.5) -55.5*
    Epithelial cells (per field)‡‡ 1.32 (1.2) 0.25 (0.4) -81.1*
    RBC (per field) NF NF NC
    Haematology
    Hemoglobin (mg/dl) 12.80 (1.14) 13.46 (0.90) 5.2 *
    RBC (morphology) Normocytic Normocytic NC
    Platelet count (x 105 per ml) 1.56 (0.2) 1.62 (0.3) 3.8
    WBC (cmm) 6650 (1170) 7050 (1268) 6.0
    ESR (mm/hr) 12.2 (6.5) 10.9 (7.8) -10.7
    Endocrinology
    Testosterone (ng/ml)4.85 (0.82) 5.99 (1.08) 23.5*
    LH (mIU/ml)7.45 (2.98) 7.33 (2.23) -1.6
    FSH (mIU/ml)8.94 (3.78) 9.78 (3.74) 9.4
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    Thanks Andrew! I didn't anticipate you would provide an entire study (Ha! just thought I would get a link or abstract), but appreciate it.

    I do think the results of the study are eye-opening and worthy of further evaluation; but I do have a few respective criticisms for discussion.

    First, and perhaps most obvious, the study was funded by Natreon. I probably don't need to say a lot more there, but it is very interesting that they are trying to gain scientific credibility and use wikipedia in the actual references of their study.

    Some of the drawbacks outside of power (an n of 35 is not very good, but probably not anything higher could be expected) are as follows:

    1. no placebo control - I know the study cites the decided upon "unethical" nature of having placebo-control, BUT understand something...this condition is not acute and as such, beginning a placebo group on suggested "therapeutics" at a later date should NEVER be frowned upon. I whole-heartedly disagree with this statement if they are seeking true validity rather than just numbers for promotion.

    2. Of those selected under 20 million sperm, the 4 cases (11% of trial participants) whom resulted in "regaining" of fertility (as defined by the study as completing successful impregnation) we at an average of only 16.525 million sperm (hardly as oligospermic as could really constitute credibility as put by their conclusion). Range: 13.5 million - 19.5 million (and the 19.5 million is relatively ridiculous to include in this analysis in my estimation).

    3. FSH increase is NOT significant (contrary to written suggestion) based on adultered p value (p<0.05).

    4. Total testosterone was evaluated without credence to free fraction, which doesn't allow a lot of valuable interpretation given potential alteration of SHBG by many plant extracts.


    Again, interesting; but one hopefully wouldn't hang their hat on this one offering in isolation.


    D_
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    Thanks for the feedback, I agree that it left many questions unanswered, no doubt anything sponsored by the original company should be taken by a grain of salt but I do notice that even my testes become a tad more plump so to speak while in it.

    Also What do you think of Long Jack?
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    Dana,
    Any news on your testosterone products that your doing with starchem labs?
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    Quote Originally Posted by andrew732 View Post
    Thanks for the feedback, I agree that it left many questions unanswered, no doubt anything sponsored by the original company should be taken by a grain of salt but I do notice that even my testes become a tad more plump so to speak while in it.

    Also What do you think of Long Jack?
    I am happy for those who use it with short-term success; will testicular fullness translate into gains at the gym...I'd say we both agree that the jury is still out.

    As for Long Jack; there is a paper that identifies the MOA as being DHEA-driven. If this is the case, you may suffer from the same sides as anything up-stream would create in a non-deficient state (read: estrogenic sides; depsite claims).


    Quote Originally Posted by keyser View Post
    Dana,
    Any news on your testosterone products that your doing with starchem labs?
    They will likely be out 1st quarter of next year. There are two pro-test items and one anti-E, which will be undergoing a little bit of research of their own momentarily as far as bloodwork and preliminary study.


    There's actually one project outside of Star Chem that will hit the end of 1st quarter/early 2nd quarter as well...but different concept as I will likely highlight an infomercial for the anti-aging crowd in low T form. An infomercial is a risky move in medicine; but given the fact that I will be releasing a book alongside of it and we are in the process of recruiting for a study to be conducted in January alongside the release...I think it will be accepted better, but we'll see (hopefully not career suicide - ha!).


    D_
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    Thanks for the Formula-X love
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    If you have any questions feel free to email me at, tommy.day@corenutritionals.com
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    Quote Originally Posted by dinoiii View Post
    As for the selenium/fulvic antagonism; we can say a few things (and I will try to respond to all questions in this thread):

    1. BioForge ingredients: It's not bad looking per se. I would add supplemental selenomethionine; BUT I am unsure how to account for the amount. See; fulvic acid when given to deficient persons is VERY antagonistic to selenium (probably some other minerals too, but selenium's the best characterized). In athletes, uncontrolled oxidation caused by exercise could promote an acutely "deficient" state that becomes VERY challenging to assess. Now, this is probably time and intensity dependent. There are a couple adaptogens like Ashwagandha (which I do like) in this, however, I do think it is a bit underdosed.

    2. PrimaVie: no different in my suggestion of selenium antagonism; but I am uncertain how you anticipate selenium deficiency to feel and this length of time on the product may not be enough time to see an effect. I am more concerned about bone mineralization and antioxidant prowess as opposed to testosterone, BUT it is noteworthy that ANYTHING that antagonizes selenium is counter-intuitive in a PRO-testosterone product. I am certain it does "hit you great" if you mean that it does make you feel better; there are plenty of adaptogenic products that do this - rhodiola is probably the best known; Ashwagandha is another (probably a reason they were coupled in BioForge product, although I am unsure). It could very well be that your multi has selenium and that is preventing "deficiency" - I have no idea as NO DATA exists on how best to accomodate for the antagonistic property and in the unique world of exercise; I am not sure one can predict it at all.



    D_
    With Bioforge out of stock everywhere I decided to pick up Ashwagandha and Tongkat on their own.

    You mentioned that the Ashwagandha was underdosed in Bioforge. The typical suggestion is to take 3 to 4 caps per day of Bioforge per day...is the Ashwagandha still underdosed at that point? What's a good starting dose to evaluate?

    I picked up Jarrow's Ashwagandha. Each cap is 225mg Sensoril.

    Thanks!
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    Quote Originally Posted by JudgementDay View Post
    Thanks for the Formula-X love
    There are very few lines I would support from top to bottom, so it is pretty hard to gain my praise, but should somehow make people think about the products I do think are well done. Formula X is sound; the doses are terrific...I have no complaints with it and give credit where it is due.


    Quote Originally Posted by dlasusa View Post
    With Bioforge out of stock everywhere I decided to pick up Ashwagandha and Tongkat on their own.

    You mentioned that the Ashwagandha was underdosed in Bioforge. The typical suggestion is to take 3 to 4 caps per day of Bioforge per day...is the Ashwagandha still underdosed at that point? What's a good starting dose to evaluate?

    I picked up Jarrow's Ashwagandha. Each cap is 225mg Sensoril.

    Thanks!
    Well, if the suggestion is to offer testosterone boost; the study that showed this was when it was dosed at 5 grams daily (yielding a 40% testosterone increase). Even at 4 caps; you wouldn't even have a gram of it.

    The study I reference is this one:

    Fertil Steril. 2010 Aug;94(3):989-96. Epub 2009 Jun 6.
    Withania somnifera improves semen quality by regulating reproductive hormone levels and oxidative stress in seminal plasma of infertile males.

    Ahmad MK, Mahdi AA, Shukla KK, Islam N, Rajender S, Madhukar D, Shankhwar SN, Ahmad S.
    Source

    Department of Biochemistry, Chhatrapati Shahuji Maharaj Medical University, and Department of Pharmacology, State Government T. T. Hospital, Lucknow, India.

    Abstract

    OBJECTIVE:

    To investigate the impact of Withania somnifera roots on semen profile, oxidative biomarkers, and reproductive hormone levels of infertile men.

    DESIGN:


    Prospective study.

    SETTING:


    Departments of Biochemistry and Urology, Chhatrapati Shahuji Maharaj Medical University, Lucknow, India.

    PATIENT(S):


    Seventy-five normal healthy fertile men (control subjects) and 75 men undergoing infertility screening.

    INTERVENTION(S):


    High-performance liquid chromatography assay procedure for quantization of vitamin A and E in seminal plasma. Biochemical parameters in seminal plasma were estimated by standard spectrophotometric procedures. Estimation of T, LH, FSH, and PRL in blood serum by RIA methods.

    MAIN OUTCOME MEASURES(S):


    Before and after the treatment, seminal plasma biochemical parameters, antioxidant vitamins, and serum T, LH, FSH, and PRL levels were measured.

    RESULT(S):


    Withania somnifera inhibited lipid peroxidation and protein carbonyl content and improved sperm count and motility. Treatment of infertile men recovered the seminal plasma levels of antioxidant enzymes and vitamins A, C, and E and corrected fructose. Moreover, treatment also significantly increased serum T and LH and reduced the levels of FSH and PRL.

    CONCLUSION(S):


    The treatment with W. somnifera effectively reduced oxidative stress, as assessed by decreased levels of various oxidants and improved level of diverse antioxidants. Moreover, the levels of T, LH, FSH and PRL, good indicators of semen quality, were also reversed in infertile subjects after treatment with the herbal preparation.
    Copyright (c) 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

    PMID:19501822[PubMed - indexed for MEDLINE]




    Again, I don't post full articles on here because I feel it detracts from the thread; however...in summary - it was a 5 gram dose used...and I would minimally hope for 1 gram daily to see even a fraction of the 40% increase worth talking about. So, 4 or 5 of the Jarrow product would likely serve you well.


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    Awesome. Thanks so much for the quick reply!
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    Correct me if I am wrong, but I believe it should be noted that the 5g dosage was just powdered root and not an extract? Again, if I am incorrect please let me know.
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    This ^^^ is what I was going to bring up. I think a gram of "sensoril" would be the equivalent of 5 grams of powdered whole plant
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    Again, that's just it. The solitary study on testosterone (which actually was presented from a fertility perspective) shows a ROOT extract (not whole plant). The main active constituents of the whole plant are alkaloids and steroidal lactones. These include tropine and cuscohygrine. The leaves contain highest concentration of the steroidal lactones, withanolides, notably withaferin A, which was the first withanolide to be isolated, and was isolated from W. somnifera (there's simply no precedent to standardize withanolides in any other way outside of using the leaves). Many manufacturers in order to achieve a high percentage of withanolide content in their extract use leaves along with the roots during extraction process. This is against the very philosophy of ashwagandha usage as prescribed by the ancient Ayurvedic texts (and the sole testosterone study). The root alone has been advocated for the extensive internal usage, whereas leaves have been advocated for topical (external) usage. Even the clinical trials world over have proved the efficacy from the root extracts.

    Now, not only that BUT the researchers in the Testosterone/Ashwagandha root trial found more antioxidant vitamins in the men after they had undergone treatment. It would seem that Ashwagandha neutralises free radicals, they speculate...there is no mention of withanolides or extracts (and rightfully so). And they suspect that this is the mechanism through which Ashwagandha increases fertility and testosterone levels.

    I am NOT saying withanolides have no benefit; but understand what is being extracted and why.

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    Thank you for bringing that to light. I was unaware of that information.

    I've always kind of wondered about extraction processes. Most of these herbs say "for centuries locals have used xxx herb" for this or that but I do not believe African tribes or what have you had an extraction facility set up other than say tea or tincture.
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    The old activate and NP's capped divanil both worked for my body recomp at the recommended dosage.
    Ursobolic also worked for me for body recomp and even for nutrient shuttling (tried it with some high carb meals for a couple of weeks as an experiment).

    Also high extract coleus did the same.

    The only three that I can say worked for me independently and stacked.

    Going to try endosurge stacked with ursobolic next or either np's divanil caps stacked with ursobolic.
    "I don't want anything. I don't want anybody. That's the worst part. When the want goes, that's bad."
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    Quote Originally Posted by koi1214 View Post
    Doc,
    Again thanks for all the help.At age 45 I am looking to run a good natty non hormonal t-boost stack for the winter time.I think I will go with DAA,Triazole,and BPS's EndoSurge www.bulkperformancesolutions.c om which has both divanil and mucana pruriens in a non proprietary formula.Great info about the fulvic acid and selenium since I do take Jarrow Formula's Selenium Synergy(5on/2off).Also,I am curious to know about the tribulus dosage you would suggest and I would believe the higher the protodioscin % the better.

    I do have a second question for you.Again at age 45,I take 2000mg of pumpkinseed oil with15mg of lycopene twice a day with food for prostate health.Is this a good combo and dose?
    As a rep I am curious about this. I can tell you from a standpoint of how I felt on it, it is my favorite and dosing is extremely liberal.
    If my direct and cynical approach bothers you, just ignore it. I'm just saying what you need to hear ;).
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    Quote Originally Posted by dinoiii View Post
    Looks like you'd have a truly nice stack honestly. I am unsure how BPS arrived at the mucuna dose and combination they have, but - with the higher % extracts of L-Dopa...it is interesting to note that lower % extracts caused higher Testosterone surges in studies when testosterone was studied. We actually explored some of the mucuna studies in the fertility thread; although I forget exactly what was discussed.
    D_
    Here is what we have in the write up about why that is the extract choices. I can ask the owner to chime in if you like. All I can say is I get amazing sleep, noticeable increase in recovery and all the signs of a GH release (especially at night) when I take EndoSurge.


    EndoSurge contains Mucuna Pruriens, a proven and well research ingredient extracted for natural L-Dopa. While L-dopa has a number of powerful benefits itself it is important that both a high extract and low extract of MP is used. The high extract closely targets certain physiological effects in the body, while the lower extract more closely targets others and allows for better bioavailability of the higher extract. To get around these differences and to maximize all of the benefits of MP we used both.

    MP has the ability to increase the body’s level of LH (luteinizing hormone). This hormone signals for the Leydig cells to produce more testosterone. More LH = more testosterone.
    If my direct and cynical approach bothers you, just ignore it. I'm just saying what you need to hear ;).
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    Doc,

    Any teasers or more info on the starchem project?
  

  
 

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