TruBlk™ Shilajit Resin Improves Sexual Function in Men with Erectile Dysfunction: A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial

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 (δ=0.53, p<0.001), and in a subset of 40 participants assessed for motility, total motility (δ=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.