Oligospermia
Conditions
Brief summary
Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.
Interventions
Tribulus terrestris
OTHERPlacebo
Placebo
Sponsors
Herbarium Laboratorio Botanico Ltda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo. | 3 months | Any improvement in sperm concentration (n/mL) |
Countries
Brazil
Outcome results
None listed