Study to evaluate the efficacy and safety of KSM- 66 Ashwagandha on sexual wellness of healthy male subjects

Phase 4

Completed

• Registration Number: CTRI/2016/05/006906
• Lead Sponsor: Shri Karthikeya Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

•Male subjects above 21 to 45 years of age and willing to give written inform Consent

•Ready for monogamous relationship for the study period

•No Significant Medical History

•Ability to understand the risks and benefits of the protocol

Exclusion Criteria

•Subject with Medical History Interfering with the results of the history.

•Subjects already on Aphrodisiac / Energy supplements

•Subjects /couples planning their family by IVF/Alternate methods

•Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression;

•Subject with significant medication use (blood pressure, beta-blockers, inhaled beta agonists, hormonal contraceptives, corticosteroid use within prior three months, psychotropic medication use within prior eight weeks;

•Subject with psychiatric hospitalization within past year

•Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Derogatis Interview for sexual functioning questionnaire after 3 weeks from randomizationTimepoint: 3 weeks from randomized into the study

Secondary Outcome Measures

Name	Time	Method
ï?­Improvement in serum testosterone and prolactin levels from baseline to end of therapy and quality of lifeTimepoint: baseline to end of therapy <br/ ><br>8 weeks