NICEVIVA
MONOGRAPH SPEC LATEST 2025

Shilajit

BOTANICALS · Evidence Monograph

Shilajit is an evidence-graded botanicals monograph evaluated across 11 peer-reviewed PubMed studies (0 meta-analyses, 1 systematic reviews, and 4 randomized controlled trials, encompassing n = 181 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 11 Studies
Meta-Analyses · Reviews 0 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 4 RCTs (4 Double-Blind)
Cumulative Participants n = 181
Reported Trial Dosages 500 mg · 1000 mg/day · 400 µg
Trial Duration Range 3 days · 12 weeks · 8 weeks
Reading Time ~6 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 11 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (500 mg · 1000 mg/day · 400 µg) over a structured 3 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
inflammation (PubMed clinical endpoint)
weight (PubMed clinical endpoint)
bone (PubMed clinical endpoint)
01

What Is Shilajit & Why Does Form Matter?

Shilajit is classified under BOTANICALS and has been investigated across 11 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (500 mg, 1000 mg/day, 400 µg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Shilajit frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (4 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Shilajit acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Shilajit an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 11 PubMed studies: 0 meta-analyses, 1 systematic reviews, and 4 randomized controlled trials (4 double-blind, n = 181 total participants).

Representative peer-reviewed findings include: • PMID:40573153 (2025) — "Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial." (Results: Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation improved pulse wave velocity, flow-mediated dilation, platelet aggregation, insulin sensitivity, and blood lip) • PMID:36546868 (2024) — "Effects of 8 Weeks of Shilajit Supplementation on Serum Pro-c1α1, a Biomarker of Type 1 Collagen Synthesis: A Randomized Control Trial." (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.) • PMID:35933897 (2022) — "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." (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)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 500 mg · 1000 mg/day · 400 µg · 1000 mg over 3 days · 12 weeks · 8 weeks · 48 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Shilajit, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (500 mg · 1000 mg/day · 400 µg) and re-evaluate efficacy after 3 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (11 Studies) · 6 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 40573153 ↗
Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.05. Key conclusion: Results: Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation improved pulse wave velocity, flow-mediated dilation, platelet aggregation, insulin sensitivity, and blood lip
View Original PubMed Abstract ↓

Background: Exercise and nutritional interventions are often recommended to help manage risk related to metabolic syndrome (MetSyn). The co-ingestion of Phyllanthus emblica (PE) with trivalent chromium (Cr) has been purported to improve the bioavailability of chromium and enhance endothelial function, reduce platelet aggregation, and help manage blood glucose as well as lipid levels. Shilajit (SJ) has been reported to have anti-inflammatory, adaptogenic, immunomodulatory, and lipid-lowering properties. This study evaluated whether dietary supplementation with Cr, PE, and SJ, or PE alone, during an exercise and diet intervention may help individuals with risk factors to MetSyn experience greater benefits. Methods: In total, 166 sedentary men and women with at least two markers of metabolic syndrome participated in a randomized, placebo-controlled, parallel-arm, and repeated-measure intervention study, of which 109 completed the study (48.6 ± 10 yrs., 34.2 ± 6 kg/m2, 41.3 ± 7% fat). All volunteers participated in a 12-week exercise program (supervised resistance and endurance exercise 3 days/week with walking 10,000 steps/day on non-training days) and were instructed to reduce energy intake by -5 kcals/kg/d. Participants were matched by age, sex, BMI, and body mass for the double-blind and randomized supplementation of a placebo (PLA), 500 mg of PE (PE-500), 1000 mg/d of PE (PE-1000), 400 µg of trivalent chromium (Cr) with 6 mg of PE and 6 mg of SJ (Cr-400), or 800 µg of trivalent chromium with 12 mg of PE and 12 mg of SJ (Cr-800) once a day for 12 weeks. Data were obtained at 0, 6, and 12 weeks of supplementation, and analyzed using general linear model multivariate and univariate analyses with repeated measures, pairwise comparisons, and mean changes from the baseline with 95% confidence intervals (CIs). Results: Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation improved pulse wave velocity, flow-mediated dilation, platelet aggregation, insulin sensitivity, and blood lipid profiles while promoting more optimal changes in body composition, strength, and

02
RANDOMIZED TRIAL (RCT) Journal of dietary supplements (2024) PMID: 36546868 ↗
Effects of 8 Weeks of Shilajit Supplementation on Serum Pro-c1α1, a Biomarker of Type 1 Collagen Synthesis: A Randomized Control Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Journal of dietary supplements; statistical significance reported at p = 0.008. Key conclusion: 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.
View Original PubMed 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.

03
RANDOMIZED TRIAL (RCT) Phytomedicine (2022) PMID: 35933897 ↗
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.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Phytomedicine; statistical significance reported at p = 0.001. Key conclusion: 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
View Original PubMed Abstract ↓

BACKGROUND: Accelerated bone loss associated with aging and estrogen withdrawal is mediated in part by increased oxidative stress and inflammation. OBJECTIVE: 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. DESIGN: Sixty postmenopausal women aged 45 - 65 years with osteopenia were randomized to receive 1 of 3 treatments daily for 48 weeks: (1) placebo, (2) 250 mg shilajit extract, or (3) 500 mg shilajit extract. Bone mineral density (BMD) of the lumbar spine (LS) and femoral neck (FN) were measured at weeks 0, 24, and 48, and circulating markers of bone turnover (CTX-1, BALP, RANKL, OPG), oxidative stress (MDA, GSH), and inflammation (hsCRP) at weeks 0, 12, 24, and 48. 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.

04
CLINICAL STUDY Phytotherapy research (2001) PMID: 11268125 ↗
Effects of Shilajit on the development of tolerance to morphine in mice.
Clinical Trial Synthesis 2001 Clinical Study published in Phytotherapy research. Key conclusion: Processed Shilajit per se, in the doses used, did not elicit any significant analgesia in mice; nor did the chronic concomitant administration of Processed Shilajit alter the morphine-induced analgesia.
View Original PubMed Abstract ↓

Effects of concomitant administration of Processed Shilajit (PS, 0.1 and 1 mg/kg, i.p.), in Swiss mice were evaluated on the development of tolerance to morphine induced analgesia in the hot plate test. Chronic administration of morphine (10 mg/kg, i.p., b.i.d.) to mice over a duration of 10 days resulted in the development of tolerance to the analgesic effect of morphine. Concomitant administration of PS with morphine, from day 6 to day 10, resulted in a significant inhibition of the development of tolerance to morphine (10 mg/kg, i.p.) induced analgesia. Processed Shilajit per se, in the doses used, did not elicit any significant analgesia in mice; nor did the chronic concomitant administration of Processed Shilajit alter the morphine-induced analgesia. These findings with Processed Shilajit indicate its potential as a prospective modifier of analgesic tolerance to morphine. Copyright 2001 John Wiley & Sons, Ltd.

05
SYSTEMATIC REVIEW International journal of impotence research (2024) PMID: 37697053 ↗
Do "testosterone boosters" really increase serum total testosterone? A systematic review.
Clinical Trial Synthesis 2024 Systematic Review published in International journal of impotence research. Key conclusion: Our findings indicate that most fail to increase total testosterone.
View Original PubMed Abstract ↓

Testosterone boosters are heavily marketed on social media and marketplaces to men with claims to significantly increase testosterone. Lax industry regulation has allowed sales of supplements to thrive in the absence of verification of their purported benefits. Our primary objective was to systematically review all data published in the last two decades on testosterone boosters and determine their efficacy. Our outcome of interest was total testosterone increase versus placebo in four different populations: male athletes, men with late-onset hypogonadism infertile men and healthy men. Following search and screening, 52 studies were included in our review, relating to 27 proposed testosterone boosters: 10 studies of cholecalciferol; 5 zinc/magnesium; 4 Tribulus terrestris and creatine; 3 Eurycoma longifolia and Withania somnifera; 2 betaine, D-aspartic acid, Lepidium meyenii and isoflavones; while the remainder were single reports. Our findings indicate that most fail to increase total testosterone. The exceptions were β-hydroxy β-methylbutyrate and betaine, which can be considered effective for male athletes. Eurycoma longifolia, a blend of Punica granatum fruit rind and Theobroma cacao seed extracts (Tesnor™) and purified Shilajit extract (PrimaVie™) can be considered possibly effective for men with late-onset hypogonadism; Eurycoma longifolia and Withania somnifera possibly effective for healthy men; and a non-hormonal aromatase inhibitor (Novadex XT™) possibly effective for male athletes. © 2023. The Author(s), under exclusive licence to Springer Nature Limited.

06
CLINICAL STUDY Journal of the American College of Nutrition (2019) PMID: 31161927 ↗
Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms.
Clinical Trial Synthesis 2019 Clinical Study published in Journal of the American College of Nutrition. Key conclusion: Shilajit supplementation improved skin microperfusion.
View Original PubMed Abstract ↓

Objective: Shilajit is a pale-brown to blackish-brown organic mineral substance available from Himalayan rocks. We demonstrated that in type I obese humans, shilajit supplementation significantly upregulated extracellular matrix (ECM)-related genes in the skeletal muscle. Such an effect was highly synergistic with exercise. The present study (clinicaltrials.gov NCT02762032) aimed to evaluate the effects of shilajit supplementation on skin gene expression profile and microperfusion in healthy adult females. Methods: The study design comprised six total study visits including a baseline visit (V1) and a final 14-week visit (V6) following oral shilajit supplementation (125 or 250 mg bid). A skin biopsy of the left inner upper arm of each subject was collected at visit 2 and visit 6 for gene expression profiling using Affymetrix Clariom™ D Assay. Skin perfusion was determined by MATLAB processing of dermascopic images. Transcriptome data were normalized and subjected to statistical analysis. The differentially regulated genes were subjected to Ingenuity Pathway Analysis (IPA®). The expression of the differentially regulated genes identified by IPA® were verified using real-time polymerase chain reaction (RT-PCR). Results: Supplementation with shilajit for 14 weeks was not associated with any reported adverse effect within this period. At a higher dose (250 mg bid), shilajit improved skin perfusion when compared to baseline or the placebo. Pathway analysis identified shilajit-inducible genes relevant to endothelial cell migration, growth of blood vessels, and ECM which were validated by quantitative real-time polymerase chain reaction (RT-PCR) analysis. Conclusions: This work provides maiden evidence demonstrating that oral shilajit supplementation in adult healthy women induced genes relevant to endothelial cell migration and growth of blood vessels. Shilajit supplementation improved skin microperfusion.

07
CLINICAL STUDY Journal of the International Society of Sports Nutrition (2019) PMID: 30728074 ↗
The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels.
Clinical Trial Synthesis 2019 Clinical Study published in Journal of the International Society of Sports Nutrition involving n = 21 participants; statistical significance reported at p = 0.022. Key conclusion: 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
View Original PubMed Abstract ↓

BACKGROUND: 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). METHODS: Sixty-three recreationally-active men ([Formula: see text] ± SD: 21.2 ± 2.4 yr.; 179.8 ± 6.3 cm; 83.1 ± 12.7 kg) volunteered to participate in this study. The subjects were randomly assigned to the high dose, low dose, or placebo group (each group: n = 21). During pre-supplementation testing, the subjects performed 2 pretest MVICs, 2 sets of 50 maximal, bilateral, concentric isokinetic leg extensions at 180°·s- 1 separated by 2-min of rest, and 2 posttest MVICs. Following 8 weeks of supplementation, the subjects repeated the pre-supplementation testing procedures. In addition, the groups were dichotomized at the 50th percentile based on pre-supplementation MVIC and baseline HYP. Mixed model ANOVAs and ANCOVAs were used to statistically analyze the dependent variables for the total groups (n = 21 per group) as well as dichotomized groups. RESULTS: For the upper 50th percentile group, the post-supplementation adjusted mean percent decline in MVIC was significantly less for the high dose group (8.9 ± 2.3%) than the low dose (17.0 ± 2.4%; p = 0.022) and placebo (16.0 ± 2.4%; p = 0.044) groups. There was no significant (p = 0.774) difference, however, between the low dose and placebo groups. In addition, for the upper 50th percentile group, the adjusted mean post-supplementation baseline HYP for the high dose group (1.5 ± 0.3 μg·mL- 1) was significantly less than both the low dose (2.4 ± 0.3 μg·mL- 1; p = 0.034) and placebo (2.4 ± 0.3 μg·mL- 1, p = 0.024) groups. 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

08
CLINICAL STUDY Journal of medicinal food (2016) PMID: 27414521 ↗
The Human Skeletal Muscle Transcriptome in Response to Oral Shilajit Supplementation.
Clinical Trial Synthesis 2016 Clinical Study published in Journal of medicinal food. Key conclusion: Microarray analysis identified a cluster of 17 extracellular matrix (ECM)-related probe sets that were significantly upregulated in muscles following 8 weeks of oral supplementation compared with the expression at the baseline visit.
View Original PubMed Abstract ↓

The objective of the present study ( clinicaltrials.gov NCT02026414) was to observe the effects of oral supplementation of a purified and standardized Shilajit extract on skeletal muscle adaptation in adult overweight/class I obese human subjects from the U.S. POPULATION: Shilajit is a mineral pitch that oozes out of Himalayan rocks. The study design consisted of a baseline visit, followed by 8 weeks of 250 mg of oral Shilajit supplementation b.i.d., and additional 4 weeks of supplementation with exercise. At each visit, blood samples and muscle biopsies were collected for further analysis. Supplementation was well tolerated without any changes in blood glucose levels and lipid profile after 8 weeks of oral supplementation and the additional 4 weeks of oral supplementation with exercise. In addition, no changes were noted in creatine kinase and serum myoglobin levels after 8 weeks of oral supplementation and the additional 4 weeks of supplementation with exercise. Microarray analysis identified a cluster of 17 extracellular matrix (ECM)-related probe sets that were significantly upregulated in muscles following 8 weeks of oral supplementation compared with the expression at the baseline visit. This cluster included tenascin XB, decorin, myoferlin, collagen, elastin, fibrillin 1, and fibronectin 1. The differential expression of these genes was confirmed using quantitative real-time polymerase chain reaction (RT-PCR). The study provided maiden evidence that oral Shilajit supplementation in adult overweight/class I obese human subjects promoted skeletal muscle adaptation through upregulation of ECM-related genes that control muscle mechanotransduction properties, elasticity, repair, and regeneration.

09
CLINICAL STUDY Archives of medical research (2012) PMID: 23131823 ↗
Can nutraceuticals prevent Alzheimer's disease? Potential therapeutic role of a formulation containing shilajit and complex B vitamins.
Clinical Trial Synthesis 2012 Clinical Study published in Archives of medical research. Key conclusion: 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.
View Original PubMed 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.

10
RANDOMIZED TRIAL (RCT) Journal of alternative and complementary medicine (New York, N.Y.) (2020) PMID: 32310691 ↗
Efficacy of Momiai in Tibia Fracture Repair: A Randomized Double-Blinded Placebo-Controlled Clinical Trial.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in Journal of alternative and complementary medicine (New York, N.Y.) involving n = 160 participants; statistical significance reported at p = 0.049. Key conclusion: Conclusions: The current study showed that oral consumption of momiai after tibial shaft fracture surgery could be a promising option to reduce the healing time.
View Original PubMed Abstract ↓

Objectives: Momiai ( shilajit, mummy, mumie, or mineral pitch) has been used traditionally in different medical systems for the treatment of a variety of ailments since hundreds of years ago. It is a natural substance found in different rocky parts of the world, formed by plants, mineral, and animal remains gradually. There is also worthwhile evidence supporting its oral use for bone repair in Persian medicine. The aim of this study was to evaluate the efficacy and safety of momiai in tibia fracture healing. Design: This study is a randomized double-blinded controlled trial. Settings/Location: Three different hospitals in Tehran, Iran. Subjects: Patients with age range of 18-60 years admitted due to new tibia fracture were enrolled after meeting the inclusion criteria. Interventions: The patients were divided into two groups randomly and received two 500 mg capsules of momiai or placebo for 28 days. Outcome measures: The process of bone healing was assessed by frequent X-ray radiographies and adverse effects were recorded. Results: Totally, 160 patients participated in the study either in two equal intervention or placebo groups. There was no significant difference between groups in terms of demographic and descriptive data. At the end of the study, the mean time of tibial bone union was 129 days in the experimental group, while it was 153 days in the placebo group (p < 0.049). There was no significant difference in the reported adverse effects between the two groups (p = 0.839). Conclusions: The current study showed that oral consumption of momiai after tibial shaft fracture surgery could be a promising option to reduce the healing time.

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