The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of guys with erectile dysfunction (ED) and with or without hypoactive sexual desire condition (HSDD), along with to monitor the security profile of the drug.
Phase IV, prospective, randomized, double-blind, placebo-controlled medical trial in parallel groups. This research study consisted of 180 males aged in between 18 and 65 years with moderate or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Clients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study.
Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112. 5mg). Each client got orally 32 film-coated tablets daily after meals, throughout the 12-week treatment period. At the end of monthly, individuals' sexual function, including ED, was evaluated by International Index of Erectile Function (IIEF) Questionnaire and Worldwide Efficacy Question (GEQ).
The primary outcome step was the modification in IIEF score after 12 weeks of treatment. Total randomization (random sorting using optimum allowable% variance) with an equivalent variety of patients in each sequence was utilized. This randomization algorithm has the restriction that unequal treatment allowance is not permitted; that is, all groups must have the exact same target sample size.
All result assessors were also blinded to group allotment. 86 clients in each group finished the study. The IIEF rating enhanced considerably in the TT group compared to the placebo group (
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