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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 erectile dysfunction (ED) and with or without hypoactive sexual desire condition (HSDD), in addition to to keep an eye on the safety profile of the drug.
Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This research study consisted of 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 consisted of in the research study.
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Each Tribestan film-coated tablet includes the active compound Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112. 5mg). Each client received orally 32 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, individuals' sexual function, consisting of ED, was examined by International Index of Erectile Function (IIEF) Questionnaire and International Efficacy Concern (GEQ).
The main outcome step was the change in IIEF score after 12 weeks of treatment. Total randomization (random sorting using maximum allowed% deviation) with an equivalent variety of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allotment is not enabled; that is, all groups need to have the very same target sample size.
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All outcome assessors were likewise blinded to group allowance. 86 clients in each group finished the study. The IIEF rating improved substantially in the TT group compared with the placebo group (