TruBlk™ Shilajit Resin Improves Sexual Function in Men with Erectile Dysfunction: A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial
- 1Research and Development, Amaara Botanicals Private Limited, Gurugram, India
Abstract
Erectile dysfunction and age-related testosterone decline are common and growing concerns among ageing men, yet current pharmacological options are constrained by tolerability, cost, and reluctance to start hormone-based therapy, leaving a real gap for safe, long-term alternatives. Shilajit, a resinous plant exudate long used in Ayurvedic medicine, is increasingly proposed to fill this gap with its bioactive constituents thought to confer adaptogenic, antioxidant, and androgen-modulating effects. However, clinical support for this use remains thin, with most existing trials small and conducted in healthy men rather than those with diagnosed erectile dysfunction. In this randomised, double-blind, placebo-controlled, multicenter trial (CTRI/2025/07/090919), 100 men aged 35-55 years with mild-to-moderate erectile dysfunction (IIEF erectile function domain score 11-25) and symptoms suggestive of androgen deficiency were enrolled across two sites. Participants received 250 mg twice daily of standardised TruBlk Shilajit resin or matched placebo for 90 days. Primary endpoints, as registered, were change from baseline in IIEF total and domain scores, total and free testosterone and cortisol, and Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) domain scores. Secondary endpoints included nitric oxide, Fatigue Severity Scale (FSS), and Participant and Investigator Global Assessments. Semen parameters were assessed in a subset of participants. IIEF total score improved significantly more in the TruBlk group (+32.1% vs. +13.6%; d=0.67, p=0.005), with significant gains in four of the five domains, namely erectile function, orgasmic function, overall satisfaction, and intercourse satisfaction (d=0.52-0.61, p=0.011-0.044), while sexual desire showed a smaller, non-significant improvement (d=0.44, p=0.109). This was accompanied by significant increases in total testosterone (+46.1% vs. +10.0%; d=0.44, p=0.030) and free testosterone (+37.4% vs. +6.8%; d=0.41, p=0.048). HIS-Q symptom domains showed a similar pattern to IIEF, with Day 90 differences favouring TruBlk in three of five domains (sexual, energy, and sleep; d=-0.59 to -0.82, p<0.02), while cognition and mood showed smaller, non-significant differences (d=-0.46 to -0.49, p=0.06-0.10). Among secondary endpoints, fatigue fell substantially more with TruBlk than with placebo, with FSS scores decreasing by 51.8% vs. 27.4% from baseline, a large between-group effect at Day 90 (d=-1.13, p<0.0001). At Day 90, 56-58% of TruBlk participants were rated "Much" or "Very Much Improved" on global assessment, compared with 12-14% of placebo. Nitric oxide showed no significant between-group difference. In an exploratory semen-analysis subset (n=57), sperm concentration increased with TruBlk relative to placebo ({delta}=0.53, p<0.001), and in a subset of 40 participants assessed for motility, total motility ({delta}=0.63, p<0.001) and progressive motility (d=0.82, p=0.014) also improved. Ninety days of standardised TruBlk Shilajit resin improved erectile function and increased total and free testosterone in men with mild-to-moderate erectile dysfunction, with improvement in several hypogonadism-related symptom domains, reduced fatigue and, in an exploratory subset, improved sperm concentration and motility. These results support standardised Shilajit resin as a promising intervention for sexual dysfunction in a clinically diagnosed population, meriting further clinical evaluation.
Related
- Short-term Rhodiola rosea supplementation improves premenstrual symptoms, reaction time, and perceived exertion in female taekwondo athletes: a randomised double-blind placebo-controlled trial
- Preprocedural CT-guided anatomical assessment shortens intubation time and improves patient and operator experience during unsedated colonoscopy: a randomised controlled trial
- Dose-dependent efficacy and renal safety of pemafibrate versus fenofibrate in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and hypertriglyceridemia: a multicenter randomized controlled, open label trial
- A Short Evidence-Based, Belief-Focused Educational Video Improves Back Pain Beliefs but Not Lifting Behaviour in Healthy Office Workers: An Exploratory Randomised Controlled Trial.
- Thymus serpyllum Extract Improves Gastrointestinal Symptoms and Modulates Fecal Gut Microbiome Composition in a Multicenter, Randomized, Placebo-Controlled Clinical Trial.
BibTeX
@misc{yadav2026trublk,
title = {{TruBlk™ Shilajit Resin Improves Sexual Function in Men with Erectile Dysfunction: A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial}},
author = {D. Yadav and U. Basu and P. H. Kurmi and M. Karwa and S. T. Reddy and A. Singh and K. Shah},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.23.26366294},
url = {https://www.medrxiv.org/content/10.64898/2026.10.23.26366294v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - TruBlk™ Shilajit Resin Improves Sexual Function in Men with Erectile Dysfunction: A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial
AU - D. Yadav
AU - U. Basu
AU - P. H. Kurmi
AU - M. Karwa
AU - S. T. Reddy
AU - A. Singh
AU - K. Shah
PY - 2026
DA - 2026/10/23
PB - medRxiv
DO - 10.64898/2026.10.23.26366294
UR - https://www.medrxiv.org/content/10.64898/2026.10.23.26366294v1
AB - Erectile dysfunction and age-related testosterone decline are common and growing concerns among ageing men, yet current pharmacological options are constrained by tolerability, cost, and reluctance to start hormone-based therapy, leaving a real gap for safe, long-term alternatives. Shilajit, a resinous plant exudate long used in Ayurvedic medicine, is increasingly proposed to fill this gap with its bioactive constituents thought to confer adaptogenic, antioxidant, and androgen-modulating effects. However, clinical support for this use remains thin, with most existing trials small and conducted in healthy men rather than those with diagnosed erectile dysfunction. In this randomised, double-blind, placebo-controlled, multicenter trial (CTRI/2025/07/090919), 100 men aged 35-55 years with mild-to-moderate erectile dysfunction (IIEF erectile function domain score 11-25) and symptoms suggestive of androgen deficiency were enrolled across two sites. Participants received 250 mg twice daily of standardised TruBlk Shilajit resin or matched placebo for 90 days. Primary endpoints, as registered, were change from baseline in IIEF total and domain scores, total and free testosterone and cortisol, and Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) domain scores. Secondary endpoints included nitric oxide, Fatigue Severity Scale (FSS), and Participant and Investigator Global Assessments. Semen parameters were assessed in a subset of participants. IIEF total score improved significantly more in the TruBlk group (+32.1% vs. +13.6%; d=0.67, p=0.005), with significant gains in four of the five domains, namely erectile function, orgasmic function, overall satisfaction, and intercourse satisfaction (d=0.52-0.61, p=0.011-0.044), while sexual desire showed a smaller, non-significant improvement (d=0.44, p=0.109). This was accompanied by significant increases in total testosterone (+46.1% vs. +10.0%; d=0.44, p=0.030) and free testosterone (+37.4% vs. +6.8%; d=0.41, p=0.048). HIS-Q symptom domains showed a similar pattern to IIEF, with Day 90 differences favouring TruBlk in three of five domains (sexual, energy, and sleep; d=-0.59 to -0.82, p<0.02), while cognition and mood showed smaller, non-significant differences (d=-0.46 to -0.49, p=0.06-0.10). Among secondary endpoints, fatigue fell substantially more with TruBlk than with placebo, with FSS scores decreasing by 51.8% vs. 27.4% from baseline, a large between-group effect at Day 90 (d=-1.13, p<0.0001). At Day 90, 56-58% of TruBlk participants were rated "Much" or "Very Much Improved" on global assessment, compared with 12-14% of placebo. Nitric oxide showed no significant between-group difference. In an exploratory semen-analysis subset (n=57), sperm concentration increased with TruBlk relative to placebo ({delta}=0.53, p<0.001), and in a subset of 40 participants assessed for motility, total motility ({delta}=0.63, p<0.001) and progressive motility (d=0.82, p=0.014) also improved. Ninety days of standardised TruBlk Shilajit resin improved erectile function and increased total and free testosterone in men with mild-to-moderate erectile dysfunction, with improvement in several hypogonadism-related symptom domains, reduced fatigue and, in an exploratory subset, improved sperm concentration and motility. These results support standardised Shilajit resin as a promising intervention for sexual dysfunction in a clinically diagnosed population, meriting further clinical evaluation.
ER -