None listed
Conditions
Interventions
None listed
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Married male participants aged 25 to 60 years both the ages inclusive. Subjects with total score greater 27 and less than 49 mild to moderate symptoms consistent with a low testosterone levels as evaluated by the Aging Males’ Symptoms Scale AMS questionnaire. Participants with mild and moderate erectile dysfunction with a score Greater than 17 & less than 21 as per the International Index of Erectile Function questionnaire. Participant must be able & willing to comply with study procedures. Participant willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: Participants who are diagnosed with another sexual disorder. Participants with serum creatinine greater than 5mg per dL. Body mass index greater than 30 Smokers and alcohol and drug abuse. Participants on PDE5 inhibitors, TRT, anti-androgen, statins, fibrates, niacin, steroid, fish oil, colistin, fiber-based laxative, phytosterol margarines, anti-diabetics, anti-platelet, thyroxine, diuretics, or beta-blockers. Participants who had undergone prostate, bladder, varicocele, colorectal, bariatric or any other surgeries during the last year, which the principal investigator thinks may affect the study outcome. History of hematological, renal or hepatic abnormalities Participants with a history of any psychiatric disorder. With the history or planning organ transplantation. Participant taking any other investigation drug and currently being a part of any other clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the AMS scale 2.Change in serum levels of total and free testosteroneTimepoint: 1.Screening, Day 30, and Day 60 2.Day 1 (Baseline), Day 30, and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in BMI 2.Change from baseline in the levels of serum SHBG 3.Change from baseline in the levels of serum DHEA. 4.Percentage of positivity on the Androgen Deficiency in Aging Males (ADAM) questionnaire. 5.Mean change in IIEF score . 6.Mean change in Fatigue Severity Scale (FSS) 7.Mean change in SF-36 (QoL) scores 8.Change in serum creatinine and BUN Timepoint: screening, and day 60 Day 1 (Baseline) and day 60. Day 1 (Baseline), day 30 and day 60. screening, day 30 and day 60;Safety Outcomes 1.Complete Blood Count 2.Blood Biochemistry 3.Vitals (Blood pressure, body temperature and pulse rate) 4.Occurrence of any AE or SAE Timepoint: 1. Screening and day 60. 2. Screening and day 60. 3. Day 1 (Baseline), day 30 and day 60. | — |
Countries
India
Contacts
Public ContactDr Sujay Gowda
Vidya Herbs Pvt Ltd
Outcome results
None listed