标准化Shilajit树脂改善轻中度勃起功能障碍男性性功能:一项随机双盲安慰剂对照多中心试验
TruBlk™ Shilajit Resin Improves Sexual Function in Men with Erectile Dysfunction: A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial
摘要
该预印本报告了一项随机、双盲、安慰剂对照、多中心试验(注册号CTRI/2025/07/090919),纳入100名35–55岁轻中度勃起功能障碍且伴雄激素缺乏症状的男性,比较标准化TruBlk™ Shilajit树脂250 mg每日两次与安慰剂共90天的效果。结果显示,IIEF总分改善显著优于安慰剂(+32.1% vs +13.6%,d=0.67),总睾酮与游离睾酮升高,疲劳评分大幅下降,总体评估改善比例更高;探索性亚组中精子浓度与活力亦有提升,一氧化氮未见组间差异。结论认为标准化Shilajit树脂可能是有前景的干预手段,但作为预印本尚需进一步验证。
原文摘要
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.
推荐理由:设计规范(随机双盲、安慰剂对照、多中心、已注册、样本量100)且同时报告激素、症状量表与精液参数,对男性性腺功能减退与精液质量领域有一定参考价值;但为预印本、单一补充剂产品、精液结果为探索性小样本亚组,影响与转化有限,可浏览不必精读。
文献解读
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