Phase 2, randomized, double-blind, two-way crossover, placebo-controlled clinical trial of the efficacy and safety of Mucuna pruriens seed extract in men with mild and mild to moderate erectile dysfunctio

Phase 2

• Conditions: Erectile dysfunction; Mucuna pruriens var. pruriens; IIEF-5; Cross-over study

• Registration Number: TCTR20240605002
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Last Update Posted: 19 August 2024
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. Male participants aged 20-60 years, who can read and write Thai, 2. Have had erectile dysfunction problems for at least 3 months, 3. Have mild and mild to moderate erectile dysfunction (a score of 12 - 21 on the International Index of Erectile Function (IIEF-5) questionnaire), 4. Willing to have sex at least 1 time in 2 weeks throughout the study, 5. Agree not to use other methods of treating erectile dysfunction including other herbs throughout the study period, 6. Research participants must be informed of the details of the clinical study, including risks and side effects that may occur during the study period, both verbally and in writing. They must sign the consent form to participate in the research voluntarily.

Exclusion Criteria

1. Currently using phosphodiesterase-5 inhibitors or have stopped using them for less than 1 week, 2. Erectile dysfunction caused by nerve injury due to spinal cord injuries or surgery on the colon, rectum, prostate, bladder, etc., 3. A history of being allergic to M. pruriens., 4. Smoke more than 20 cigarettes per day, 5. Have heart disease, 6. Have kidney disease, 7. Have uncontrolled hypertension, 8. Patients with uncontrolled diabetes, 9. Have uncontrolled hypercholesterolemia, 10. Have ever had surgery or radiation on the pelvic region or other conditions that may affect the effectiveness of M. pruriens seed extract, 11. Have cancer, 12. Have clinically significant abnormalities in the results of routine laboratory tests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified