To evaluate the Efficacy and Safety of study product i.e., LYCO3 in Male Subjects who Suffering from Erectile Dysfunctio
- Conditions
- Health Condition 1: N529- Male erectile dysfunction, unspecified
- Registration Number
- CTRI/2024/07/071171
- Lead Sponsor
- utragen Pharma Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Male participants aged above 18 years who are in good health.
2) Participants with a Body Mass Index (BMI) less than 40.
3) Individuals with a positive Androgen Deficiency in Aging Males (ADAM) questionnaire score, defined as an affirmative response (yes) to either of the following questions: Do you have a decreased sex drive/libido? or Are your erections less strong? or a positive response to any three other questions on the ADAM questionnaire.
4) Individuals with an International Index of Erectile Function (IIEF) assessment score between 11-25.
5) Individuals willing to engage in at least four sexual encounters over next 8-week period.
6) Men who are committed to refraining from the use of phosphodiesterase 5 inhibitors (e.g., Viagra, Levitra, Cialis), supplements, or other herbal supplements throughout the study duration.
7) Subjects willing to provide written informed consent and adhere to all study procedures.
1) Individuals with current or previous history of prostate or testicular cancer.
2) Participants with a past surgical history of prostatectomy.
3) Men who have received past or current treatment for erectile dysfunction, including intracavernosal injections or penile prosthesis.
4) Use of steroids within the past 3 months, including prednisone, cortisone injections, and inhaled steroids.
5) History of or current use of anabolic steroids (e.g., testosterone), testosterone analogs (e.g., DHEA, DHEAS), antidepressants, or anti-androgen medications (e.g., aldactone, tagamet, estrogens).
6) History of spinal cord injury; and use of systemic anticoagulants (e.g., coumadin, clopidogrel).
7) Presence of clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, hepatic, renal, immunological, endocrine disorders (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
8) Active smokers or individuals with a history of high alcohol intake (2 standard drinks per day).
9) Known hypersensitivity to herbal drugs, nutritional supplements, or foods.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change in International index of erectile function (IIEF) scores from screening to different assessment points. <br/ ><br>2) Change in Erection Hardness Score (EHS) from screening to different assessment points.Timepoint: Day 0, Day 45 and Day 90
- Secondary Outcome Measures
Name Time Method 1) Change in serum testosterone levels from screening to end of the study. <br/ ><br>2) Change in ADAM questionnaire score from screening to end of the study. <br/ ><br>3) The change in vital signs (blood pressure, pulse rate, body temperature) from screening to the end of the study. <br/ ><br>4) The changes in haematological (CBC), liver (Sr. SGPT) and kidney function (serum creatinine) parameters from screening to the end of the study. <br/ ><br>5) Occurrence of the treatment-related adverse events during study period.Timepoint: Day 0, Day 45 and Day 90