Efficacy and safety of Tribulus terrestris products for men with low sperm count
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
This study tests if a natural supplement from Tribulus terrestris can help men with low sperm count improve their condition safely.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | Male |
| Sponsor | Herbarium Laboratorio Botanico Ltda Industry-sponsored |
| Locations | 1 site (Valinhos, São Paulo) |
| Trial ID | NCT06260007 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of products derived from Tribulus terrestris in men diagnosed with oligospermia, a condition characterized by low sperm count. Participants will receive either the investigational product or a placebo, and the study aims to determine if the benefits of the treatment outweigh any associated risks. The study is designed to carefully monitor participant safety and health throughout the intervention period.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 25 to 60 who have been diagnosed with oligospermia and have a sexual partner.
Not a fit: Patients with severe oligospermia, anatomical changes, or those who have previously undergone treatment for oligospermia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for men with oligospermia, potentially improving fertility outcomes.
How similar studies have performed: While the use of Tribulus terrestris has been explored in other contexts, this specific approach in treating oligospermia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \- Male; 2. \- Ages 25 and 60; 3. \- Diagnosis of oligospermia; 4. \- With sexual partner; 5. \- Indication of drug treatment with steroid hormones, precursors or analogues. Exclusion Criteria: 1. \- Severe oligospermia 2. \- Anatomical change 3. \- Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues; 4. \- BMI 35; 5. \- Participant who presents liver enzyme and creatinine values above the upper limit of normality; 6. \- History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone; 7. \- Hypersensitivity to any ingredient present in the formulation; 8. \- Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety; 9. \- Proven infertility of the partner; 10. \- History of genetic disorder; 11. \- History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk; 12. \- Active cancer at the discretion of the Investigator; 13. \- Participants with pregnant and breastfeeding partners; 14. \- Cycling and horse riding more than 3 hours per week; 15. \- Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism; 16. \- Smoking greater than half a pack per day or equivalent.
Where this trial is running
Valinhos, São Paulo
- Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda — Valinhos, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.