Shilajit
CLINICAL STUDIES ON THE FOLLOWING INGREDIENTS:
Can Nutraceuticals Prevent Alzheimer's Disease? Potential Therapeutic Role of a Formulation Containing Shilajit and Complex B Vitamins
Abstract
Alzheimer's disease (AD) is a brain disorder displaying a prevalence and impact in constant expansion. This expansive and epidemic behavior is concerning medical and public opinion while focusing efforts on its prevention and treatment. One important strategy to prevent this brain impairment is based on dietary changes and nutritional supplements, functional foods and nutraceuticals. In this review we discuss the potential contributions of shilajit and complex B vitamins to AD prevention. We analyze the status of biological studies and present data of a clinical trial developed in patients with mild AD. Studies suggest that shilajit and its active principle fulvic acid, as well as a formula of shilajit with B complex vitamins, emerge as novel nutraceutical with potential uses against this brain disorder.
Results: In a clinical study the nutraceutical formulation composed of Andean shilajit and complex B vitamins was administered to a group of healthy volunteer subjects as a memory enhancer. Informed consent was obtained from all subjects. The reported effects of this treatment were mainly related to improvements in memory and as an energy enhancer (Figure 3).
Source: https://www.sciencedirect.com/science/article/abs/pii/S0188440912002925?via%3Dihub
Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia
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.
Source: https://onlinelibrary.wiley.com/doi/10.1111/j.1439-0272.2009.00956.x
Shilajit: evaluation of its effects on blood chemistry of normal human subjects
Abstract
The effect of Shilajit on blood chemistry was studied in normal human volunteers. Administration of two gms of Shilajit for 45 days did not produce any significant change in physical parameters i.e. blood pressure, pulse rate and body weight and similarly no change was observed in hematological parameters. A significant reduction in Serum Triglycerides, Serum cholesterol with simultaneous improvement in HDL Cholesterol was seen, besides Shilajit also improved antioxidant status of volunteers. Results of study suggest hypolipidemic and strong antioxidant activity of Shilajit.
Source: Sharma P, Jha J, Shrinivas V, Dwivedi LK, Suresh P, Sinha M. Shilajit: evalution of its effects on blood chemistry of normal human subjects. Anc Sci Life. 2003 Oct;23(2):114-9. PMID: 22557121; PMCID: PMC3330960.
https://pubmed.ncbi.nlm.nih.gov/22557121/
Effects of 8 Weeks of Shilajit Supplementation on Serum Pro-c1α1, a Biomarker of Type 1 Collagen Synthesis: A Randomized Control Trial
Abstract
Type 1 collagen is an abundant structural protein with importance to the skin, eyes, bones, ligaments, tendons, and muscles. Shilajit supplementation has been shown to increase gene expression of collagen synthesis, however, it is unclear if increased gene expression translates to increases in circulating levels. Therefore, the purpose of the present study was to examine the effects of 8 weeks of daily supplementation with 500 mg·d−1 and 1000 mg·d−1 of Shilajit versus placebo on serum pro-c1α1, a biomarker of type 1 collagen synthesis. Thirty-five recreationally trained men (mean ± SD: age = 21.1 ± 1.8 yrs; body mass = 80.7 ± 12.4 kg; height = 180.9 ± 6.7 cm) volunteered to participate in this study. Mixed factorial and one-way ANOVAs were used to analyze mean differences between groups, with follow-up t-tests when necessary.
Individual subject responses were assessed using the minimal clinically important difference and Chi-squared tests. There were significant (Low dose: p = 0.008, d = 1.2; High dose: p = 0.007, d = 1.3) increases in serum pro-c1α1 from pre- (Low dose: 42.5 ± 12.4 ng·mL−1; High dose: 42.7 ± 12.7 ng·mL−1) to post-supplementation (Low dose: 82.3 ± 46.5 ng·mL−1; High dose: 113.1 ± 78.7 ng·mL−1) for the low and high dose groups, however, no change (p > 0.05) for the placebo group. A greater proportion (p = 0.03) of subjects exhibited increases in pro-c1α1 that exceeded the minimal clinically important difference in the high dose Shilajit group (75%) compared to the placebo group (30%), but no differences (p = 0.06) between the low dose Shilajit group (69%) and placebo. In conclusion, 8 weeks of Shilajit supplementation with 500 and 1000 mg·d−1 increased type 1 collagen synthesis as indicated by serum levels of pro-c1α1.
Source: Neltner, T. J., Sahoo, P. K., Smith, R. W., Anders, J. P. V., Arnett, J. E., Schmidt, R. J., … Housh, T. J. (2022). Effects of 8 Weeks of Shilajit Supplementation on Serum Pro-c1α1, a Biomarker of Type 1 Collagen Synthesis: A Randomized Control Trial. Journal of Dietary Supplements, 21(1), 1–12.
https://www.tandfonline.com/doi/full/10.1080/19390211.2022.2157522
The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels
Abstract
Shilajit is a safe, fluvic mineral complex exudate that is common to Ayurvedic medicine and is composed of fulvic acids, dibenzo-α-pyrones, proteins, and minerals. The purpose of this study was to examine the effects of 8 weeks of Shilajit supplementation at 250 mg·d− 1 (low dose) and 500 mg·d− 1 (high dose) versus placebo on maximal voluntary isometric contraction (MVIC) strength, concentric peak torque, fatigue-induced percent decline in strength, and serum hydroxyproline (HYP).
Conclusions: The results of the present study demonstrated that 8 weeks of PrimaVie® Shilajit supplementation at 500 mg·d− 1 promoted the retention of maximal muscular strength following the fatiguing protocol and decreased baseline HYP. Thus, PrimaVie® Shilajit supplementation at 500 mg·d− 1 elicited favorable muscle and connective tissue adaptations.
Source: Keller JL, Housh TJ, Hill EC, Smith CM, Schmidt RJ, Johnson GO. The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels. J Int Soc Sports Nutr. 2019 Feb 6;16(1):3. doi: 10.1186/s12970-019-0270-2. PMID: 30728074; PMCID: PMC6364418.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6364418/
Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers
Abstract
Purified Shilajit, an Ayurvedic rasayana, was evaluated in healthy volunteers of age between 45 and 55 years for its effect on male androgenic hormone viz. testosterone in a randomised, double-blind, placebo-controlled clinical study at a dose of 250 mg twice a day. Treatment with Shilajit for consecutive 90 days revealed that it has significantly (P < 0.05) increased total testosterone, free testosterone and dehydroepiandrosterone (DHEAS) compared with placebo. Gonadotropic hormones (LH and FSH) levels were well maintained.
Source: Pandit S, Biswas S, Jana U, De RK, Mukhopadhyay SC, Biswas TK. Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers. Andrologia. 2016 Jun;48(5):570-5. doi: 10.1111/and.12482. Epub 2015 Sep 22. PMID: 26395129.
https://pubmed.ncbi.nlm.nih.gov/26395129/
Effects of oral Shilajit tablets on sexual function and sexual quality of life among reproductive-aged women: a triple-blind randomized clinical trial
Background: Shilajit is mentioned in the “Kama Sutra” as a potent enhancer of sexual desire. This study aimed to investigate the effects of oral Shilajit tablets on sexual function and sexual quality of life among women of reproductive age. Methods: Forty-eight reproductive-aged women participated in a placebo-controlled triple-blind clinical trial. The intervention group took oral Shilajit tablets (200 mg) twice daily for 60 days and the control group took the placebo. Data collection tools were Sexual Quality of Life-Female and Female Sexual Function Index. Data were collected before the intervention, 30, 60, and 90 days after the start of the study. Results: Forty-three women completed the study. The mean score of total sexual function in the intervention group was significantly higher than before the intervention (P < 0.001). The mean score of sexual function was 28.93 after 90 days in the intervention group while it was 22.09 in the control group. This finding was observed in most domains of the sexual function index. The mean score of sexual quality of life increased after 60 days of intervention in both groups; however, the difference was not statistically significant (P = 0.094).
Conclusion: The study indicated that Shilajit, as a complementary therapy, may improve sexual function and most of its domains; while there was no effect on improving the quality of sexual life.
Source: Mosavi S, Tabarrai M, Tansaz M, et al. Effects of oral Shilajit tablets on sexual function and sexual quality of life among reproductive-aged women: a triple-blind randomized clinical trial. Tradit Med Res. 2023;8(11):66. doi:10.53388/TMR20230305002
https://www.tmrjournals.com/article.html?J_num=1&a_id=2817
Effect of purified Shilajit (Asphaltum punjabianum) on oxidative stress, arterial stiffness and endothelial function in elderly with hypertension: A randomised controlled study
Abstract
Growing evidence showed involvement of vascular oxidative stress in the development of endothelial dysfunction, arterial stiffness and hypertension. Many clinical trials of antioxidants have proven unsuccessful in prevention of atherosclerosis and cardiovascular events. There is a need of new therapies that reduce age- and hypertension associated arterial stiffness in elderly individuals. We aimed to determine if shilajit (Asphaltum punjabianum), a natural phytocomplex which is immunomodulator, anti-inflammatory, antioxidant and antiaging, can reduce oxidative stress and improve arterial function in the elderly with hypertension.
Results: Between-group analysis showed a significant decrease in oxidative stress markers: Malondialdehyde (P < 0.001) and oxidised-low-density lipoproteins (P = 0.015); and increase in total antioxidant capacity (P = 0.002), superoxide dismutase (P < 0.001) and reduced glutathione (P < 0.001) with complementary therapy of shilajit. There was no change in the markers of arterial stiffness and endothelial function.
Conclusion: These findings suggest that shilajit may be of value as a natural antioxidant to reduce oxidative stress in elderly hypertension patients.
Source: Patil SG, Patil KA, Sarashetti R, Hadimur K. Effect of purified Shilajit (Asphaltum punjabianum) on oxidative stress, arterial stiffness and endothelial function in elderly with hypertension: A randomised controlled study. Indian J Physiol Pharmacol 2023;67:197-204.
Shilajit: A Natural Phytocomplex with Potential Procognitive Activity
Abstract
Shilajit is a natural substance found mainly in the Himalayas, formed for centuries by the gradual decomposition of certain plants by the action of microorganisms. It is a potent and very safe dietary supplement, restoring the energetic balance and potentially able to prevent several diseases. Recent investigations point to an interesting medical application toward the control of cognitive disorders associated with aging, and cognitive stimulation. Thus, fulvic acid, the main active principle, blocks tau self-aggregation, opening an avenue toward the study of Alzheimer′s therapy. In essence, this is a nutraceutical product of demonstrated benefits for human health. Considering the expected impact of shilajit usage in the medical field, especially in the neurological sciences, more investigations at the basic biological level as well as clinical trials are necessary, in order to understand how organic molecules of shilajit and particularly fulvic acid, one of the active principles, and oligoelements act at both the molecular and cellular levels and in the whole organism.
Conclusion: Shilajit is a potent and very safe dietary supplement, potentially able to prevent several diseases, but its main medical application now appears to come from its actions in benefit of cognition and potentially as a dietary supplement to prevent Alzheimer’s disease. In essence, this is a nutraceutical product. Considering the expected impact of shilajit applications in the medical field, especially in neurological sciences, more investigations at the basic biological level are necessary, and certainly well-developed clinical trials, in order to understand how its active principles act at molecular and cellular levels.
Source: https://onlinelibrary.wiley.com/doi/10.1155/2012/674142
Safety and Efficacy of Shilajit (Mumie, Moomiyo)
Abstract
Shilajit (mumie; moomiyo, mummiyo) has been used for a wide variety of illnesses and conditions for many years. However, relatively few well-controlled human studies have been conducted on the effects of shiliajit, although a growing number of studies have been published in recent years involving animal and in vitro systems. The safety of shilajit is well documented based on animal and human studies. Various research studies indicate that shilajit exhibits antioxidant, anti-inflammatory, adaptogenic, immunomodulatory, and anti-dyslipidemic properties. Animal and human studies indicate that shilajit enhances spermatogenesis.
Furthermore, animal and human data support its use as a ‘revitalizer’, enhancing physical performance and relieving fatigue with enhanced production of ATP. Key constituents in shilajit responsible for these effects appear to be dibenzo-α-pyrones and fulvic acid and their derivatives. Various mechanistic studies provide support for the above observed effects. Additional well-controlled human and animal studies involving the use of standardized products are needed. Copyright © 2013 John Wiley & Sons, Ltd.
Source: https://onlinelibrary.wiley.com/doi/abs/10.1002/ptr.5018
Shilajit extract reduces oxidative stress, inflammation, and bone loss to dose-dependently preserve bone mineral density in postmenopausal women with osteopenia: A randomized, double-blind, placebo-controlled trial
Abstract
Accelerated bone loss associated with aging and estrogen withdrawal is mediated in part by increased oxidative stress and inflammation. Investigate dietary supplementation with a standardized aqueous extract of shilajit with clinically demonstrated antioxidant, anti-inflammatory, and collagen-promoting activity on attenuating bone loss in postmenopausal women with osteopenia.
Results: BMD of both the LS and FN progressively decreased in women receiving placebo but was dose-dependently attenuated with shilajit extract supplementation, resulting in significantly increased percentage changes from baseline in BMD at 24- and 48-weeks in both supplemented groups compared to placebo (p < 0.001). CTX-1, BALP, and RANKL decreased, whereas OPG increased, in both groups supplemented with the shilajit extract, but not in the placebo group, resulting in significantly decreased or increased percentage changes from baseline, respectively. MDA was significantly decreased (p < 0.001) and GSH was significantly increased (p < 0.001) in both supplemented groups compared to placebo from week 12 for the duration of the study. Progressive reductions in hsCRP were observed in both supplemented groups, resulting in significantly decreased percentage changes from baseline in supplemented women compared to placebo (p < 0.001).
Conclusion: Daily supplementation with this shilajit extract supports BMD in postmenopausal women with osteopenia in part by attenuating the increased bone turnover, inflammation and oxidative stress that coincides with estrogen deficiency in this population at increased risk for osteoporosis and bone fractures.
Source: https://www.sciencedirect.com/science/article/abs/pii/S0944711322004135
References:
- https://www.sciencedirect.com/science/article/abs/pii/S0188440912002925?via%3Dihub
- https://onlinelibrary.wiley.com/doi/10.1111/j.1439-0272.2009.00956.x
- https://pubmed.ncbi.nlm.nih.gov/22557121/
- https://www.tandfonline.com/doi/full/10.1080/19390211.2022.2157522
- https://pmc.ncbi.nlm.nih.gov/articles/PMC6364418/
- https://pubmed.ncbi.nlm.nih.gov/26395129/
- https://www.tmrjournals.com/article.html?J_num=1&a_id=2817
- https://ijpp.com/effect-of-purified-shilajit-asphaltum-punjabianum-on-oxidative-stress-arterial-stiffness-and-endothelial-function-in-elderly-with-hypertension-a-randomised-controlled-study/
- https://onlinelibrary.wiley.com/doi/10.1155/2012/674142
- https://onlinelibrary.wiley.com/doi/abs/10.1002/ptr.5018
- https://www.sciencedirect.com/science/article/abs/pii/S0944711322004135