The main goals were to compare the efficacy 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 libido disorder (HSDD), in addition to to keep track of the safety profile of the drug.
Phase IV, prospective, randomized, double-blind, placebo-controlled scientific trial in parallel groups. https://tribestanoriginal.com/what-is-the-best-tribulus-terrestris-product/ included 180 males aged 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.
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 client received orally 32 film-coated tablets daily after meals, during the 12-week treatment period. At the end of every month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Effectiveness Concern (GEQ).
The main outcome measure was the change in IIEF rating after 12 weeks of treatment. Total randomization (random sorting utilizing maximum permitted% variance) with an equivalent variety of patients in each sequence was used. This randomization algorithm has the constraint that unequal treatment allocation is not allowed; that is, all groups need to have the same target sample size.
All outcome assessors were likewise blinded to group allowance. 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared to the placebo group (