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The primary 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 men 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, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 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 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 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 tribestan 250mg of each month, individuals' sexual function, including ED, was evaluated by International Index of Erectile Function (IIEF) Questionnaire and Global Effectiveness Question (GEQ).
The primary outcome step was the modification in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using optimum allowable% deviation) with an equivalent variety of patients in each series was utilized. This randomization algorithm has the restriction that unequal treatment allowance is not enabled; that is, all groups should have the same target sample size.
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All result assessors were also blinded to group allotment. 86 patients in each group finished the study. The IIEF score improved significantly in the TT group compared with the placebo group (