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The main objectives were to compare the effectiveness of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in contrast with placebo, for the treatment of men with impotence (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to keep track of the security profile of the drug.

Phase IV, potential, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Clients with ED and high blood pressure, diabetes mellitus, and metabolic syndrome were consisted of in the research study.

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Each Tribestan film-coated tablet consists of the active compound Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112. 5mg). Each patient received orally 32 film-coated tablets daily after meals, throughout the 12-week treatment period. At the end of monthly, participants' sexual function, consisting of ED, was examined by International Index of Erectile Function (IIEF) Questionnaire and International Efficacy Question (GEQ).

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The primary outcome step was the change in IIEF rating after 12 weeks of treatment. Total randomization (random sorting using optimum allowable% discrepancy) with an equivalent number of clients in each sequence was utilized. This randomization algorithm has the restriction that unequal treatment allotment is not allowed; that is, all groups need to have the exact same target sample size.

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All result assessors were also blinded to group allocation. 86 clients in each group completed the research study. The IIEF rating enhanced considerably in the TT group compared with the placebo group (