Study of Tribulus Terrestris Products for Treating Oligospermia in Men Aged 25 to 60

What this Trial Is About

This research aims to evaluate the effectiveness and safety of products based on Tribulus terrestris, L. in men diagnosed with oligospermia, a condition characterized by low sperm count. The study focuses on men between 25 and 60 years old who have a sexual partner and an indication for drug treatment involving steroid hormones or related compounds. The trial is a phase 4, randomized, double-blind study comparing different doses of Tribulus terrestris with a placebo. Participants will be randomly assigned to receive one of several study groups Tribulus terrestris at doses of 94 mg, 250 mg, or 280 mg, or a placebo. The treatment period lasts for 3 months, during which participants will take the assigned product as directed. The study is designed to carefully manage any risks while assessing how the products affect sperm quality compared to placebo. During the study, men will undergo evaluations of their spermogram to measure changes in sperm characteristics. Researchers will monitor safety through clinical assessments and laboratory tests, including liver enzyme and creatinine levels. The primary outcome is the effectiveness of each product in improving sperm parameters over the 3-month period. Participants health and well-being will be closely followed throughout the study.

Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia