Clinical study of ayurvedic and Homeopathic medicines add on to intralesional verapamil in Peyronieâ??s disease

Phase 2

• Conditions: Health Condition 1: N489- Disorder of penis, unspecified

• Registration Number: CTRI/2023/04/051309
• Lead Sponsor: All India Institute of Medical Sciences, Bhopal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Sexually active men age >=18 years,

2. International Index of erectile Function (IIEF-15 > 16)

3. Stable PD (penile deformity unchanged for 6 months), months associated with a soft nodule or plaque and/or painful erection and/or a recent change in penile curvature.

4. Presence of a palpable plaque, and has a single axis penile curvature (less than 90 degrees)

5. Ultrasound to confirm the presence of a penile plaque

Exclusion Criteria

1. Presence of hinge or lateral indentation or hour-glass deformity,

2. Patients at the chronic or fibrotic stage of PD

3. Previous medical, surgical and EWST treatment for PD

4. Calcified plaques or hourglass deformity as defined at duplex Doppler ultrasonography

5. Significant concomitant Erectile Dysfunction (IIEF-15 score < 16)

6. Any medical treatment for ED before or during the study

7. Severe penile curvature incompatible with sexual intercourse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Penile curvature (degree).Timepoint: Baseline <br/ ><br>After 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Change of plaque size (mm), measured by ultrasound. <br/ ><br> <br/ ><br>2. International Index of Erectile function questionnaire (IIEF-5) score <br/ ><br>Timepoint: Baseline <br/ ><br>After 12 weeks