None listed
Conditions
Interventions
Intervention1: ABE-0520: Oral administration of ABE-0520 capsules twice a day for 84 days
Control Intervention1: Placebo: Oral administration of Placebo capsules twice a day for 84 days
Sponsors
Akay Natural Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with morning total testosterone level less than 300 ng/dL and confirming by repeating measurement of total testosterone level. 2. At screening, subject with androgen deficiency symptoms 3.Subjects with no history of surgical or medical castration, diagnosed erectile dysfunction or any physical disability that may limit sexual function 4. Non-smoker 5. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of Uncontrolled diabetes and hypertension,Diagnosable mental health disorder,Cancer, Thyroid diseases, Liver and gall bladder diseases, Renal failure, Chronic fatigue syndrome, Asthma, Cardiovascular disorders, Subjects diagnosed with prostate cancer or benign prostatic hypertrophy, had an acute genitourinary disorder or history of genital surgery. 2. Subjects who has been administered any PDE-V inhibitors (sildenafil, tadalafil, or vardenafil) and chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen medication within the four weeks prior to enrollment and during the entire course of the study 3. Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months 4. Subjects having symptoms of viral infection, including COVID-19 infection 5. Subjects with known hypersensitivity to Ashwagandha extract 6. History of smoking, alcohol/drug abuse 7. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 8. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 9. Any condition that in opinion of the Investigator, does not justify the subjectâ??s participation in the study. 10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hormonal levelsTimepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Immunity biomarker levelsTimepoint: Day 0, Day 42, Day 84;Changes in Questionnaire based assessmentsTimepoint: Day 0, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed