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The primary 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 males with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to keep an eye on the security profile of the drug.
Phase IV, potential, 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. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were consisted of in the study.
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Each Tribestan film-coated tablet includes the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112. 5mg). Each patient received orally 32 film-coated tablets daily after meals, throughout the 12-week treatment duration. At tribulus sopharma of each month, individuals' sexual function, consisting of ED, was examined by International Index of Erectile Function (IIEF) Survey and Worldwide Efficacy Question (GEQ).
The main outcome measure was the modification in IIEF rating after 12 weeks of treatment. Complete randomization (random sorting using optimum allowable% variance) with an equal number of clients in each series was used. This randomization algorithm has the limitation that unequal treatment allocation is not enabled; that is, all groups need to have the very same target sample size.
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All outcome assessors were also blinded to group allowance. 86 clients in each group completed the study. The IIEF rating improved significantly in the TT group compared with the placebo group (