A clinical trial to study the effects of Ashwagandha on semen quality in infertile males.

Phase 3

Not yet recruiting

• Conditions: Male infertility, unspecified. Ayurveda Condition: RETODOSHAH,

• Registration Number: CTRI/2022/09/046086
• Lead Sponsor: Dr Md Zabihullah

Brief Summary

The present study is a randomized, double-blind,placebo-controlled trial that aims toinvestigate the efficacy and safety of 1g Ashwagandha twice daily for 3 months on semen quality ininfertile males. It is a single-center trial evaluating  118 participants. The primary outcome measures are the changes in sperm quality parameters, viz. sperm concentration,sperm motility, and sperm vitality in infertile males following threemonths of Ashwagandha treatment as compared to three months of placebotreatment. The secondary outcome

measures are the safety of therapy underinvestigation by comparing hepatic function and renal function testsbefore and after the intervention period.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 118

Inclusion Criteria

• Apparently healthy males coming for semen analysis in the andrology laboratory, Department of Physiology, AIIMS, Patna 2.
• Age between 18-45 years 3.
• Males with sperm count less than 40 million /ml and more than 0.5 million/ml.

Exclusion Criteria

• Any other major comorbidities (Diabetes mellitus, hypertension etc.) 2.
• Males with urological diseases 3.
• Males on any hormonal (steroids) treatment 4.
• Subject taking drug known to affect semen parameters 5.
• Males with sperm count less than 0.5 million/ml and more than 40 million /ml.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in sperm count	12 weeks

Secondary Outcome Measures

Name	Time	Method
Increase in	1.Aspartate aminotransferase (AST)

Trial Locations

Locations (1)

AIIMS, Patna; 🇮🇳 Patna, BIHAR, India

AIIMS, Patna

🇮🇳Patna, BIHAR, India

Dr Md Zabihullah

Principal investigator

7895932225

zabihm81@aiimspatna.org