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CTRI Number  CTRI/2022/09/046086 [Registered on: 30/09/2022] Trial Registered Prospectively
Last Modified On: 09/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Ashwagandha on semen quality in infertile males. 
Scientific Title of Study   Evaluation of efficacy and safety of Ashwagandha (Withania) on semen quality in infertile males. A Randomised Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Md Zabihullah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology AIIMS Patna Phulwari Sharif Patna Bihar

Patna
BIHAR
801507
India 
Phone  7895932225  
Fax    
Email  zabihm81@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Zabihullah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology AIIMS Patna Phulwari Sharif Patna Bihar

Patna
BIHAR
801507
India 
Phone  7895932225  
Fax    
Email  zabihm81@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr Md Zabihullah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology AIIMS Patna Phulwari Sharif Patna Bihar

Patna
BIHAR
801507
India 
Phone  7895932225  
Fax    
Email  zabihm81@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Patna 
 
Primary Sponsor  
Name  Dr Md Zabihullah 
Address  Department of Physiology AIIMS, Patna Phulwari Sharif Patna, Bihar 801507 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Zabihullah  AIIMS, Patna  Andrology Laboratory Department of Physiology 2nd floor, Admin. Building
Patna
BIHAR 		 7895932225

zabihm81@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N469||Male infertility, unspecified. Ayurveda Condition: RETODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha, Reference: Charaka Samhita and Susruta Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: Ashwagandha Churna-1 g, morning and evening after meal with luke-warm milk will be given.
2Comparator Arm (Non Ayurveda)-PlaceboMatching placebo 1 g twice daily orally after meals with luke-warm milk for 3 months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. 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
 
 
ExclusionCriteria 
Details  1. 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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in sperm count   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in
1.Aspartate aminotransferase (AST)
2.Alanine aminotransferase (ALT)
3.Total and Direct Bilirubin
4.Creatinine 		 12 weeks 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   03/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [zabihm81@aiimspatna.org].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The present study is a randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of 1g Ashwagandha twice daily for 3 months on semen quality in infertile 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 three months of Ashwagandha treatment as compared to three months of placebo treatment. The secondary outcome

measures are the safety of therapy under investigation by comparing hepatic function and renal function tests before and after the intervention period.

 
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