A clinical study to evaluate the safety and efficacy of ABE-0520 on middle-aged male subjects with androgen deficiency
- Registration Number
- CTRI/2021/01/030391
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method