Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
None listed
Sponsors
Kudos Laboratories India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Gender or Age- Male participants aged 25 to 65 years. 2.Diagnosis: Clinically established mild-to-moderate erectile dysfunction, confirmed by investigator assessment and an IIEF-15 total score between 11 and 25 (inclusive) at baseline. 3.Relationship Status: Living with or having a regular sexual partner willing to cooperate with study assessments. 4.Health Status: o Medically stable, judged suitable for participation based on medical history and physical examination. o Able and willing to abstain from any other sexual-enhancement medications or supplements during the study. 5.Consent: Capable of understanding study procedures and providing written informed consent prior to participation. 6.Compliance: Willing and able to comply with study requirements, including diary completion and visit attendance.
Exclusion criteria
Exclusion criteria: 1. Severe erectile dysfunction with IIEF score less than 10, showing complete inability to achieve or maintain an erection sufficient for penetration. 2. History of secondary sexual disorders such as premature ejaculation, decreased libido of psychogenic origin, or other diagnosed sexual disorders. 3. Presence of major medical conditions including: 4. Uncontrolled hypertension with blood pressure equal to or above 160 by 100 mmHg, diabetes mellitus with HbA1c more than 8.5, severe dyslipidemia, hepatic or renal impairment. 5. Recent myocardial infarction, stroke, or major cardiovascular event within the last six months. 6. Known endocrine or neurological disease affecting sexual function. 7. History of surgical or anatomical causes such as radical prostatectomy, pelvic surgery, or pelvic radiotherapy. 8. Use of drugs or substances that may interfere with study outcomes including: 9. Use of PDE5 inhibitors, testosterone therapy, or other erectile dysfunction drugs within two weeks prior to baseline. 10. Current use of antidepressants, antipsychotics, opioids, or other medications known to impair sexual function. 11. Current alcohol or substance abuse. 12. Known hypersensitivity or intolerance to any herbal, mineral, or excipient component of VajiAmritVati. 13. Participation in another clinical trial or exposure to any investigational product within 30 days prior to enrollment. 14. Serious psychiatric disorder or any condition that, in the investigator s judgment, could interfere with subject compliance or data reliability. 15. Any other clinically significant laboratory or physical finding that may pose undue risk or interfere with study outcomes as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in International Index of Erectile Function (IIEF-15) total score from Baseline (Day 0) to End of Study (Day 14 2 days). The IIEF-15 is a validated tool measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.Timepoint: Day 0, Day 7 2, Day 14 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Erection Hardness Scale (EHS) score from Baseline to Day 14 2 days. 2. Changes in libido, frequency of sexual activity, sexual satisfaction, and stamina assessed via patient-reported outcome questionnaires at Day 0, Day 7 2 days, and Day 14 2 days. 3. Safety and tolerability assessed by monitoring adverse events, serious adverse events, and vital signs throughout the study period (Day 0 to Day 14 2 days).Timepoint: Day 0, Day 7 2 days, and Day 14 2 days | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed