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The main goals were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of males with impotence (ED) and with or without hypoactive sexual desire condition (HSDD), along with to keep track of the safety profile of the drug.

Phase IV, potential, randomized, double-blind, placebo-controlled clinical trial in parallel groups. tribulus sopharma included 180 males aged in 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 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 duration. At the end of each month, participants' sexual function, including ED, was examined by International Index of Erectile Function (IIEF) Questionnaire and International Efficacy Question (GEQ).

The primary result procedure was the modification in IIEF rating after 12 weeks of treatment. Total randomization (random sorting utilizing optimum allowed% variance) with an equal variety of clients in each sequence was utilized. This randomization algorithm has the restriction that unequal treatment allowance is not allowed; that is, all groups should have the same target sample size.

All result assessors were likewise blinded to group allocation. 86 clients in each group completed the study. The IIEF score enhanced significantly in the TT group compared with the placebo group (