Health Condition 1: R888- Abnormal findings in other body fluids and substances
Conditions
Interventions
Intervention1: Physta: Physta 100mg capsules (100 mg of standardized Eurycoma longifolia extract with 250 mg maltodextrin) and Physta 200mg capsules (200 mg of standardized Eurycoma longifolia extract
Sponsors
Biotropics Malaysia Berhad
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 50-70 years, Male 2. BMI>=18 and 3. Testosterone levels 4. In a stable heterosexual relationship for at least 6 months 5. Volunteer must be able, willing and likely to fully comply with study procedures and restrictions. 6. Judged by the investigator to be in general good health on the basis of medical history. 7. Volunteer agree to not to take any other product which can boost testosterone during study period 8. Volunteer willing to sign the informed consent
Exclusion criteria
Exclusion criteria: 1. History of prostate cancer 2. Abnormal prostate exam (induration, asymmetry, or nodules) 3. Benign Prostate Hyperplasia symptoms 4. Penile anatomical abnormalities 5. Premature ejaculation 6. Cardiovascular disease 7. Resting hypotension (resting systolic blood pressure 8. Resting hypertension (resting systolic blood pressure >170mmHg or diastolic pressure >110mmHg) 9. Primary hypoactive sexual desire 10. Volunteer taking any other investigation drug and currently being a part of any other clinical trial/research. 11. Any other underlying conditions which might affect serum testosterone levels (total and free). 12. Volunteers with known hypersensitivity to test drug or any of the excipients of this extract 13. Abnormal /Elevated kidney & liver function test 14. High alcohol intake ( > 2standard drinks per day) 15. History of depression 16. Uncontrolled Diabetes 17. History of Seizures 18. Clinically significant chronic hematological disease 19. Significant active peptic ulceration 20. History of syncope within the last 6 months prior to entry to the study 21. History of malignancy within the past 5 years 22. Any congenital spinal cord deformities or traumatic spinal cord injuries 23. Any congenital or traumatic brain injuries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the serum total testosterone levels and free testosterone levels from baseline to the end of 90 days compared across two conditions (placebo and test product)Timepoint: At screening, day 14, day 30, day 60 and Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the BMI (Body Mass Index) from baseline to the end of 90 days compared across two conditions (placebo and test product)Timepoint: At screening or randomization, day 14, day 30, day 60 and Day 91;Change in the levels of HBA1C, IGF-1, Thyroxin Profile (T3, T4 & TSH), Free T3, Cortisol and muscle tone from baseline to the end of 90 days compared across two conditions (placebo and test product)Timepoint: At screening or randomization and Day 91;Change in the levels of SHBG (Sex hormone binding globulin) and DHEA (Dehydroepiandrosterone) from baseline to the end of 90 days compared across two conditions (placebo and test product)Timepoint: At screening or randomization, day 14, day 30, day 60 and Day 91;Change in total score on the quality of life questionnaires including AMS (Aging Male Symptoms Score) and FSS (Fatigue Severity Scale) from baseline to the end of 90 days compared across two conditions (placebo and test product)Timepoint: At randomization, day 14, day 30, day 60 and Day 91 | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Oriana Hospital, Varanasi, UP
Outcome results
None listed