Shilajit Human Clinical Research: What the Evidence Shows

Shilajit Human Clinical Research: What the Evidence Shows

Shilajit is sold as a testosterone booster, a fertility aid, a bone builder and an energy tonic, often with confident “clinically proven” language. Behind those claims sits a surprisingly short list of human trials. Most are small, and several used the same branded extract. This review sets out what those trials tested, what they found, what they did not find, and how far the results can reasonably be stretched. It treats positive and null findings alike.

Shilajit Clinical Evidence: Executive Summary

• Human trials exist, but few. In my searches I identified five human studies with enough verifiable detail to tabulate: three randomized placebo-controlled trials in men or women, one 48-week bone trial, and one uncontrolled fertility study.
• Signals appear in several areas. These include testosterone in healthy middle-aged men, semen parameters in men with low sperm counts, strength retention after fatiguing exercise, bone density in postmenopausal women with osteopenia, and sexual-function scores in women.
• Each signal rests on one trial. I did not find an independent replication of any outcome.
• Most outcomes are surrogate markers. Hormone levels, lab values and bone density were measured. Fertility outcomes (pregnancy), fractures, and symptoms in daily life largely were not.
• Industry links are likely. The trial products named in the sources I reviewed were mostly a single branded extract (PrimaVie, Natreon). Funding disclosures need checking in each full text.
• No meta-analysis was found. I located no pooled analysis of shilajit randomized trials, though I can’t rule one out.
• Long-term safety is unestablished. The longest trial I found ran 48 weeks.

The honest summary: shilajit has promising early signals, not demonstrated efficacy.

The Research Question Behind Shilajit Human Research

Shilajit is a mineral-rich, tar-like exudate from mountain rock layers, consisting mainly of humic substances (including fulvic acid), plant and microbial metabolites, and trace minerals. Its composition varies by source and processing, which matters for every trial below.

This review asks one structured question:

• Population: Humans of any age, health status or sex.
• Intervention: Oral shilajit, raw, processed, purified or standardized.
• Comparator: Placebo, no treatment, or baseline.
• Outcomes: Any clinical, hormonal, functional or safety endpoint.

Does oral shilajit improve measurable health outcomes in humans, and how reliable is that evidence?

How We Searched for Shilajit Clinical Studies

What was and wasn’t searched

This is a targeted evidence check, not a PRISMA systematic review. Here is exactly what was done:

• Searched: A general web search engine, using queries combining “Shilajit” with randomized trial, systematic review, meta-analysis, testosterone, oligospermia, bone density, muscle strength, and sexual function. Searches ran in October 2026, with no date restriction.
• Used to confirm details: Journal abstracts (where accessible), trade-press summaries of trials, a trial registry entry, and reference lists in reviews.
• Not searched: I did not run structured queries in PubMed/MEDLINE, Embase, Cochrane CENTRAL, Scopus, or Web of Science. PubMed could not be opened directly. Non-English and regional databases (including Indian and Iranian indexes) were not searched.
• Consequence: Eligible trials may exist that this review missed. Treat the study list as a verified subset, not a complete census.

Inclusion and exclusion criteria

• Included: Human studies of oral shilajit, prioritizing randomized controlled trials, then other controlled designs, then uncontrolled clinical studies.
• Excluded from the main table: Animal and cell studies, narrative reviews (discussed separately), multi-ingredient formulas where shilajit’s effect can’t be isolated, and studies where I couldn’t verify basic design details.

Recommended search string for your own verification

For a full replication, run this in PubMed, Embase and Cochrane CENTRAL, and register the protocol first (for example on PROSPERO):

(shilajit OR mumie OR mummiyo OR moomiyo OR momiai OR "mineral pitch" OR PrimaVie) AND (human OR trial OR randomized OR clinical)

Screen in duplicate, extract data in duplicate, and assess bias with the Cochrane RoB 2 tool.

Shilajit Efficacy by Health Outcome

Testosterone and androgen markers (healthy men)

The best-known trial randomized 75 healthy men aged 45 to 55 to purified shilajit or placebo for 90 days (Pandit et al., 2016). Trade-press coverage of the paper reports the dose as 250 mg twice daily. Total testosterone rose by about 20% and free testosterone by about 19% in the shilajit group, with DHEAS also reported as increased (about 31% in secondary summaries). Secondary sources disagree on how LH and FSH behaved, so check the full text. I did not verify baseline values or whether results stayed within the normal range. No symptom or function outcomes appeared in the summaries I saw.

Sperm parameters (oligospermia)

Biswas et al. (2010) screened 60 infertile men and enrolled 35 with sperm counts below 20 million/mL. They took 100 mg of processed shilajit twice daily for 90 days. Secondary sources report that 28 completed the study, with total sperm count up about 61%, normal sperm up about 19%, motility up roughly 12 to 17%, and testosterone up about 23%. As far as I can tell from the abstract, there was no placebo group, so natural variation in semen quality over three months can’t be separated from any treatment effect. Pregnancy and live-birth outcomes were not reported in the summaries I saw.

Muscle strength and collagen turnover

Keller et al. (2019) randomized 63 men (21 per group) to 250 mg/day, 500 mg/day or placebo for 8 weeks. The published significant finding applies only to a subgroup: among participants in the upper half of baseline strength, the 500 mg group lost less strength after a fatiguing protocol (about 9% decline versus about 17% for 250 mg and 16% for placebo). The 250 mg group did not differ from placebo. A lower hydroxyproline (a collagen-breakdown marker) was also reported in a baseline-defined subgroup. The summaries I saw do not report a clear whole-sample benefit, which weakens confidence.

Bone density (postmenopausal osteopenia)

Pingali and Nutalapati (2022) randomized 60 postmenopausal women with osteopenia to placebo, 250 mg or 500 mg of the extract for 48 weeks. The authors concluded that shilajit preserved bone mineral density in a dose-dependent way alongside reductions in oxidative stress, inflammation and bone turnover markers. This is the longest trial I found, but it is a single trial with a surrogate endpoint. No fracture outcomes were reported in the sources I saw.

Female sexual function

Mosavi et al. (2023) randomized 48 reproductive-aged women in an Iranian triple-blind trial. They took 200 mg of shilajit twice daily for 60 days, and 43 completed. Total sexual-function scores were reported as improved. Secondary sources describe the sexual quality-of-life result inconsistently, so confirm it in the full text. This is a patient-reported outcome from one small trial.

Other claimed outcomes

I did not find adequate human trials supporting shilajit for cognition, chronic fatigue, high-altitude illness, diabetes or immunity. Claims in those areas rest on animal or laboratory work, or on narrative reviews. They are not human evidence. One 2003 report (Sharma et al.) is described in secondary sources as giving 2,000 mg/day of processed shilajit to 20 normal subjects versus 10 on placebo for 45 days, but I could not verify its findings.

Human Studies Table: Shilajit Randomized Controlled Trials

Effect sizes are as reported in abstracts or secondary summaries. They should be checked against full texts, including confidence intervals, which I could not verify.

Human mechanistic studies (not clinical-outcome trials): Das et al. (2016, skeletal muscle) and a 2020 skin study (Das et al.) reported gene-expression changes after oral shilajit in small human groups. These show biological activity, not clinical benefit.

Study Design Quality and Risk of Bias

My assessment is a preliminary, abstract-level judgment, not a formal RoB 2 appraisal.

• Randomization and blinding: Four of the five studies are described as randomized with placebo; the fifth (fertility) is not controlled. Whether allocation concealment was adequate is unverified.
• Attrition: The fertility study lost 7 of 35 participants; the women’s sexual-function trial lost 5 of 48. Other trials’ completion rates were not verified.
• Outcome selection: The strength trial’s key finding came from subgroup splits, a recognized source of false-positive results.
• Multiplicity: Several trials measured many hormones or markers. I did not see correction for multiple comparisons in the summaries.
• Placebo and product matching: Not verifiable at abstract level.
• Overall: I’d class the risk of bias as some concerns to high, pending full-text appraisal.

Participants, Dose, Form and Duration

• Participants: Mostly men (three of five studies), including healthy middle-aged men, active men and men with low sperm counts. Women appear in two trials. No children, no older adults beyond age 65, and no people with serious illness were studied in the trials I verified.
• Form: “Shilajit” is not one product. Trials used purified, processed or standardized extracts, and results can’t be transferred to raw resin, powders or other brands.
• Dose: From 200 to 500 mg/day, mostly split into two doses. The only dose-comparison trials (250 vs 500 mg) found effects mainly at the higher dose.
• Duration: 8 weeks to 48 weeks. Evidence beyond one year is absent.

Endpoints and Shilajit Research Findings

Primary endpoints in these trials were mostly laboratory or performance measures: hormone concentrations, semen counts, strength decline after a test protocol, bone density, and questionnaire scores.

Null and weaker findings to keep in view:

• The 250 mg dose in the strength trial did not beat placebo.
• The strength trial’s benefit was not shown across all participants in the summaries I saw.
• Sexual quality-of-life results are described inconsistently.
• No study reported hard clinical outcomes: pregnancy, fractures, injury rates, or testosterone-deficiency symptoms.
• Gonadotropin (LH/FSH) findings differ across secondary sources.

Statistical Versus Clinical Significance

A p-value shows that a difference is unlikely to be chance alone. It does not show the difference matters to a patient.

• Testosterone: A roughly 20% increase in a healthy man whose level was already in the normal range may not change how he feels or functions. Without symptom data, clinical meaning is unknown.
• Sperm count: A 61% rise from a low baseline can still leave a count below normal. Natural variation and regression to the mean could explain part of an uncontrolled change.
• Strength: A smaller post-exercise decline in a lab test isn’t the same as better athletic performance or injury protection.
• Bone density: A preserved BMD is encouraging, but the goal is fewer fractures, which a 60-person trial can’t show.
• Sexual function: Questionnaire changes may be meaningful, but thresholds for a “minimal clinically important difference” were not verified here.

Funding and Conflicts of Interest

• Trade-press reports link four of the five studies’ products to Natreon’s PrimaVie, and describe the Keller study as one of several trials on that extract.
• Whether the manufacturer funded, supplied product for, or employed authors on each trial must be checked in the funding and disclosure statements of each paper. I did not verify them.
• Industry sponsorship is not proof of bias, but it is associated with more favorable reported results across supplement research, so independent replication matters.
• The Iranian women’s trial used a different product and was registered in the Iranian clinical trials registry. Its funding was not verified.

Consistency Across Trials

Consistency can’t really be assessed, because no outcome has been tested more than once with a comparable design.

• Testosterone rose in the healthy-men trial and in the uncontrolled fertility study, but they differ in design, population and dose. This is suggestive, not replication.
• The only outcome where two doses were compared showed effects only at the higher dose, which fits a dose-response story but is based on subgroup data.
• Different products, doses and durations make cross-trial comparison weak.

Systematic Reviews and Meta-Analyses

• Narrative reviews exist (for example Agarwal et al., 2007; Wilson et al., 2011; Stohs, 2014; Carrasco-Gallardo et al., 2012). They describe composition, traditional use and early data, and they repeatedly call for better-designed human studies. One review concluded that bioactivity claims lacked substantial evidence at the time.
• A recent systematic review (PROSPERO-registered) looked at shilajit in cancer and found only preclinical studies and no randomized trials in humans.
• A meta-analysis of shilajit randomized trials: I did not find one. With so few trials and such varied outcomes, pooling would currently be hard to justify.
• I also saw titles for other systematic reviews online but could not verify their quality or methods, so I haven’t relied on them.

Evidence Grading by Outcome

Framework (predefined, GRADE-inspired): Start at “High” for randomized trials and “Low” for uncontrolled studies. Downgrade one level each for risk of bias, imprecision (small samples), indirectness (surrogate endpoints), inconsistency, and publication or funding concerns. Rate “Insufficient” if no adequate human trial was found. These are my preliminary judgments from abstract-level information. They need formal independent grading before anyone cites them as definitive.

Limitations

• This review: It was not a full systematic search (see methodology). Abstract-level and secondary-source data limit accuracy.
• The evidence: Small trials, single-product studies, short durations, surrogate outcomes, few women, and no independent replications.
• Product variability: Shilajit composition varies by origin and processing. Raw or unpurified material can carry contaminants, so trial products can’t be treated as equivalent to what’s on a shelf.
• Publication bias: Positive small trials are more likely to be published, and null trials may be missing.
• Safety: Trials were not powered to detect uncommon adverse events, and a small number of studies cannot establish long-term safety.

Bottom Line and Research Priorities

Interpretation. The human data suggest that certain purified shilajit extracts may influence some biomarkers in the studied groups. The strongest signals involve testosterone in healthy middle-aged men and bone density in postmenopausal women with osteopenia. They are best read as hypothesis-generating. Shilajit efficacy for any health condition has not been established.

Research priorities:

1. Independent, preregistered replication of the testosterone and bone trials with larger samples.
2. Placebo-controlled fertility trials with pregnancy and live-birth outcomes.
3. Clinically meaningful endpoints: fractures, symptoms, function.
4. Trials longer than one year, with systematic adverse-event monitoring and contaminant testing.
5. Head-to-head comparison of extracts, plus certificates of analysis.
6. Full reporting of funding, conflicts, CONSORT flow and all prespecified outcomes.

Practical note. If you’re considering a supplement, discuss it with a clinician, especially with a hormone-sensitive condition, fertility concerns, osteoporosis treatment, pregnancy or breastfeeding, or regular medication.

Frequently Asked Questions

Are there human clinical trials on shilajit?
Yes, but few. I verified one 90-day testosterone RCT, one uncontrolled fertility study, an 8-week strength RCT, a 48-week bone RCT, and a 60-day women’s sexual-function RCT.

Does shilajit raise testosterone?
One RCT in 75 healthy men aged 45 to 55 reported about a 20% rise in total testosterone over 90 days. It hasn’t been independently replicated, and clinical benefit wasn’t shown.

Does shilajit improve sperm count?
An uncontrolled study in men with oligospermia reported higher counts and motility after 90 days. Without a placebo group, that can’t establish cause, and pregnancy outcomes weren’t reported.

Is shilajit good for bone health?
A 48-week RCT in 60 postmenopausal women with osteopenia reported preserved bone density. It’s a single trial with no fracture data.

Does shilajit improve strength or performance?
Results are limited to a subgroup in one 8-week trial. Real-world performance benefit hasn’t been shown.

Is there a meta-analysis of shilajit trials?
I didn’t find one. Too few comparable trials exist for a meaningful pooled analysis.

What dose was used in trials?
Between 200 and 500 mg per day of specific purified or processed extracts. These doses don’t automatically apply to other products.

Is shilajit proven safe long-term?
No. The longest trial I found was 48 weeks, and trials weren’t designed to detect rare effects.

Is “clinically proven” a fair claim for shilajit?
Generally not. “Preliminary human data suggest...” is more accurate for most outcomes.

Your Next Step

Before you rely on a shilajit claim, check four things: how many trials support it, whether independent groups replicated it, whether the outcome is a lab number or a real-world result, and whether the product matches the extract tested. If you publish or sell in this area, run the full PRISMA search above and have the grades independently verified.

This article is educational and does not replace medical advice.

References

Details marked [verify] were confirmed only through secondary sources or abstracts and must be checked against the original before publication.

1. 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;48(5):570-575. PMID 26395129.
2. Biswas TK, Pandit S, Mondal S, et al. Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia. Andrologia. 2010;42(1):48-56. PMID 20078516.
3. 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;16:3. doi:10.1186/s12970-019-0270-2. PMID 30728074.
4. Pingali U, Nutalapati C. 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. Phytomedicine. 2022;105:154334. doi:10.1016/j.phymed.2022.154334.
5. Mosavi 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. Traditional Medicine Research. 2023;8(11):66. [verify author list]
6. Das A, et al. The human skeletal muscle transcriptome in response to oral shilajit supplementation. J Med Food. 2016;19(7):701-709. [verify]
7. Das A, et al. Skin transcriptome of middle-aged women supplemented with natural herbo-mineral shilajit shows induction of microvascular and extracellular matrix mechanisms. 2020. [verify journal and details]
8. Sharma P, et al. Shilajit: evaluation of its effects on blood chemistry of normal human subjects. Anc Sci Life. 2003. [verify; findings not confirmed]
9. Stohs SJ. Safety and efficacy of shilajit (mumie, moomiyo). Phytother Res. 2014. [verify volume and pages]
10. Agarwal SP, et al. Shilajit: a review. Phytother Res. 2007;21(5):401-405. PMID 17295385.
11. Wilson E, et al. Review on shilajit used in traditional Indian medicine. J Ethnopharmacol. 2011;136(1):1-9. PMID 21530631. [verify]
12. Carrasco-Gallardo C, Guzmán L, Maccioni RB. Shilajit: a natural phytocomplex with potential procognitive activity. Int J Alzheimers Dis. 2012. [verify]
13. Pre-clinical evaluation of Shilajit in cancer: a systematic review. PMC12866998. [verify journal and authors]
14. Iranian Registry of Clinical Trials, entry for the oral Shilajit tablet and women’s sexual function trial (en.irct.ir/trial/51845).
15. Trade-press summaries used only to cross-check design details: NutraIngredients, “Shilajit supplements may boost testosterone for healthy men: RCT” (Oct 6, 2015); NutraIngredients, “Natreon’s Shilajit extract shows bone health promise for postmenopausal women: RCT” (Aug 11, 2022). Replace with the primary papers.

Identified but not appraised (titles only): a randomized trial of momiai in tibia fracture repair; a trial on serum pro-C1a1 after 8 weeks of shilajit (J Diet Suppl, 2022); and a 12-week multi-ingredient trial combining chromium, Phyllanthus emblica and shilajit. Retrieve and appraise these before finalizing the evidence table.

Suggested Internal Links

• “What Is Shilajit?” (identity page) from the first mention of shilajit
• “Shilajit Safety, Side Effects and Contraindications” from the safety and long-term-gap sections
• “How Shilajit Works: Mechanisms of Action” from the transcriptome note
• “Shilajit Forms, Purification and Quality Testing” from the product-variability limitation
• “Shilajit and Testosterone”, “Shilajit and Bone Health” and “Shilajit for Male Fertility” from the outcome subsections
• Your Zinc safety page, where the zinc and mineral-content discussion overlaps

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Notes before publishing

• Keyword density: “Shilajit” is a single-word primary keyword, so staying under 2% means roughly 65 to 70 mentions in a page this length. I used synonyms and “the extract” to limit it, but the headings, tables and references push the count up. Check it in a density tool and trim table mentions if needed.
• H2 coverage: Every secondary keyword appears in an H2: clinical evidence, human research, clinical studies, efficacy, randomized controlled trials, and research findings.
• Plagiarism: The text is original synthesis, but I can’t run a scan, and I can’t guarantee any score. Check it in Copyscape or a similar tool.
• Verification is required before this goes live. Check every effect size, sample size, completion count, funding statement and [verify] reference against the full papers. That is the main E-E-A-T risk here.
• Word count: This is shorter than the 4,000 target because I only wrote what I could support. Once you pull full texts, add the exact effect sizes, confidence intervals, baseline values and COI statements. That is how to reach the length honestly.
• E-E-A-T: Add a named author and a clinical or scientific reviewer with real credentials.