Effect Of Ashwagandha on Male Sexual Health

Phase 2

• Conditions: Health Condition 1: N468- Other male infertility

• Registration Number: CTRI/2022/01/039243
• Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male patient Aged >=20 to <= 50 years.

2. Subject satisfying any one of the following criteria.

• Subject having Erectile dysfunction IIEF A Score in between 11-21.

• Premature Ejaculation IPE Score in between 18-28.

• Other Sexual dysfunction IIEF B Score in between 21-30.

2. Not suffering from any chronic disease.

3. Patients have common medical co-morbidities.

• Controlled hypertension (<=140/90 mm/hg)

• Controlled diabetes (FBS<=126mg/dl/ PP<=200mg/dl or HbA1c between 6-6.9 %).

Exclusion Criteria

1. History of hypothyroidism, cardiovascular disease, psychiatric disorders.

2. Participants addicted to smoking, tobacco and alcohol consumption.

3. Subject under treatment for the male infertility.

4. Anatomical deformity of the penis such as severe penile fibrosis or Peyronieâ??s disease or phimosis.

5. Subjects suffering from congenital anomalies.

6. Subjects who underwent major surgical procedures in last 6 months.

7. Subjects with any unstable heart disease or known case of MI, Unstable angina.

8. Subjects who have completed participation in any other clinical trial during the past six month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in any of the following questionnaire score. <br/ ><br>a) International Index of Erectile function subscale A <br/ ><br>b) International Index of Erectile function subscale B <br/ ><br>c) Index of Premature EjaculationTimepoint: 30 days

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is the improvement in the semen parameters and serum <br/ ><br>testosterone level from baseline (day 0) after 30 days of therapy. <br/ ><br>Timepoint: 30 days