A double blind, randomized, placebo controlled clinical trial of Aswagandha (Withania somnifera) and Shilajit in male sexual dysfunction with special reference to erectile dysfunction and premature ejaculation due to mild to moderate stress disorders

The objective of the study will be to determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit for male sexual disorders with special emphasis on erectile dysfunction (ED) and pre-mature ejaculation (PME). This is an 8-week randomized, double-blind, placebo-controlled trial to compare the effectiveness of therapies. The primary inclusion criteria are males aged 25 to 60 who are major complainers of sexual disorders, with emphasis on ED and PME, and who also complain of anxiety, depression, or sleep abnormalities caused by chronic stress. 90 subjects will be randomized into the following 3 groups: (a) Aswagandha 500 mg/day, (b) Shilajit 250 mg/day, and (c) Placebo (inert) 500 mg/day. All test medicines will be taken before dinner for 8 weeks.

After enrollment, the follow-up visits will be at 4 weeks and 8 weeks. There will be an additional follow-up at 9 weeks to assess treatment discontinuation symptoms, if any. Clinical efficacy will be assessed using the following instruments at screening (Day 0) and final visit (8 weeks): (a) PEDT, (b) EHS, (c) IIEF-5, (d) PSS, (e) HAM-A, (f) HAM-D, and (g) DESEA. Biochemical efficacy will be assessed at the same interval through (a) serum cortisol, (b) serum testosterone, and (c) serum LH and FSH levels. Clinical tolerability will be assessed using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). Other than that detail, hematological (CBC), biochemical (fasting blood sugar, fasting lipids panel, thyroid function test, liver function test panel, renal function test panel), serology (HIV1/2, HBsAg, anti-HCV, VDRL), and urine routine and microscopy panel will be assessed for safety profile.Withdrawal effect will be measured using the Clinical Institute Withdrawal Assessment Scale - Benzodiazepines (CIWA-B) at 9 weeks 1 after discontinuation of test medicine.

Clinical efficacy will be assessed by examining the improvement score at treatment endpoint in a multivariable linear regression analysis with group and baseline score as the independent variables. A completer analysis of clinical efficacy will also be performed, and a sensitivity analysis on patients who were at least 90% adherent during the course of the study. All other efficacy and safety outcomes will be assessed in completer analyses because imputation of missing data in these contexts would be scientifically meaningless. Alpha for statistical significance will be set at p<0.05.