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

Launched by HERBARIUM LABORATORIO BOTANICO LTDA · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of products made from a plant called Tribulus terrestris in men who have a condition known as oligospermia, which means they have a lower than normal sperm count. The study is currently looking for male participants aged between 25 and 60 who have been diagnosed with oligospermia and have a sexual partner. To be eligible, participants should not have severe oligospermia or any serious health issues that could interfere with the study, such as certain cancers or liver problems.

If you decide to join, you will be part of a study that aims to see if the benefits of these products outweigh any potential risks. The research team will closely monitor your health throughout the trial to ensure your safety. It's important to know that participants will need to avoid certain behaviors, like heavy drinking or smoking, during the study. If you're curious about how this treatment may help improve sperm health, this trial could be an opportunity to explore that while contributing to important research.

Gender

MALE

Eligibility 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.