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The primary objectives 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), in addition to to keep track of the safety profile of the drug.
Phase IV, potential, randomized, double-blind, placebo-controlled medical trial in parallel groups. This research 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 hypertension, diabetes mellitus, and metabolic syndrome were included 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). tribestan got orally 32 film-coated tablets daily after meals, during the 12-week treatment duration. At the end of each month, individuals' sexual function, including ED, was examined by International Index of Erectile Function (IIEF) Questionnaire and Global Effectiveness Concern (GEQ).
The primary result procedure was the change in IIEF score after 12 weeks of treatment. Total randomization (random sorting using maximum allowable% deviation) with an equal variety of clients in each series was utilized. This randomization algorithm has the restriction that unequal treatment allocation is not permitted; 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 patients in each group completed the research study. The IIEF rating improved significantly in the TT group compared to the placebo group (
