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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 men with impotence (ED) and with or without hypoactive libido disorder (HSDD), in addition to to monitor the security profile of the drug.

Stage IV, prospective, 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. tribestan with ED and high blood pressure, diabetes mellitus, and metabolic syndrome were consisted of in the study.

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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, during the 12-week treatment period. At the end of every month, individuals' sexual function, consisting of ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Worldwide Efficacy Question (GEQ).

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The primary outcome step was the modification in IIEF score after 12 weeks of treatment. Complete randomization (random sorting utilizing optimum allowable% 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.

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All result assessors were likewise blinded to group allocation. 86 clients in each group finished the study. The IIEF score improved substantially in the TT group compared to the placebo group (