Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
None listed
Sponsors
Renovision Exports Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Male subjects aged twenty five to sixty years. -Subjects who are willing and able to provide written informed consent before starting any study related procedures. -Subjects with a confirmed diagnosis of erectile dysfunction for more than six months and less than five years. -Subjects having a baseline International Index of Erectile Function erectile function score between eleven and twenty five, indicating mild to moderate erectile dysfunction. -Subjects who are in a stable relationship for at least three months before screening and have a history of at least two sexual attempts per month for at least one month prior to enrollment. -Subjects who are willing to follow all study procedures, attend scheduled visits, take the study medication as instructed, and complete the study diary. -Subjects who are generally healthy, with no major active infections or clinically significant medical conditions, as assessed by the investigator.
Exclusion criteria
Exclusion criteria: -Subjects with known hypogonadism or structural abnormalities of the penis, including severe penile fibrosis. -Subjects with a history of significant heart related diseases such as congestive heart failure, life threatening irregular heart rhythm, or ischemic heart disease. -Subjects with an ongoing history of alcohol abuse or drug abuse. -Subjects with neuromuscular disorders that affect sexual function. -Subjects diagnosed with secondary hypertension. -Subjects having severe complications of diabetes such as heart disease, kidney disease, or foot ulcer. -Subjects who have participated in another clinical trial within the last thirty days prior to enrollment. -Subjects with known allergy or hypersensitivity to any of the ingredients of Tatkal Capsules. -Subjects who are unwilling or unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Mean change from Baseline (Day 0) to End-of-Study (Day 30 ± 2 days) in the International Index of Erectile Function (IIEF) total score. The IIEF is a validated, multidimensional instrument measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.Timepoint: - Baseline (Day 0) - End of Study (Day 30± 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in EHS score Day 0 Day 30 2 -Change in Vigor Vitality Score VVQ6 Day 0 Day 30 2 -Patient Reported Outcomes libido frequency satisfaction stamina and improvement in sexual performance -Safety parameters AEs ADRs incidence vitalsTimepoint: - Baseline (Day 0) - End of Study (Day 30± 2 days) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed