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

Stage IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study 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. Patients 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 compound Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112. 5mg). Each patient got orally 32 film-coated tablets daily after meals, during the 12-week treatment duration. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and International Effectiveness Concern (GEQ).

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The main result measure was the modification in IIEF score after 12 weeks of treatment. Total randomization (random sorting using optimum permitted% discrepancy) with an equal number of patients in each sequence was utilized. This randomization algorithm has the restriction that unequal treatment allotment is not enabled; that is, all groups need to have the exact same target sample size.

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All outcome assessors were likewise blinded to group allocation. 86 clients in each group completed the study. The IIEF rating improved significantly in the TT group compared to the placebo group (