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CTRI Number  CTRI/2022/01/039243 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 25/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 Effect Of Ashwagandha on Male Sexual Health 
Scientific Title of Study
Modification(s)  		 Efficacy and Safety of Ashwagandha (Withania Somnifera ) Root Powder on Male Sexual Health: A Double-Blind Randomized Placebo-Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahil Garg 
Designation  PG Scholar 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karolbagh New Delhi

Central
DELHI
110005
India 
Phone  9015172346  
Fax    
Email  garg.sahil499@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Rajan 
Designation  HOD (Associate Professor) 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karolbagh New Delhi

Central
DELHI
110005
India 
Phone  9354925026  
Fax    
Email  sujataa.rajan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujata Rajan 
Designation  HOD (Associate Professor) 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karolbagh New Delhi

Central
DELHI
110005
India 
Phone  9354925026  
Fax    
Email  sujataa.rajan@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital Karolbagh New Delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sahil Garg  Ayurvedic and Unani Tibbia College and Hospita  Department of Kriya Sharira, Physiology lab Ground floor Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
Central
DELHI 		 09015172346

garg.sahil499@gmail.com 
Dr Sahil Garg  Ayurvedic and Unani Tibbia College and Hospital   Department of Kriya Sharira, Physiology lab Ground floor Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
Central
DELHI 		 09015172346

garg.sahil499@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N468||Other male infertility. Ayurveda Condition: SUKRAVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha, Reference: API, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information:
2Comparator Arm (Non Ayurveda)-Roasted Wheat flourIt will be administered in dosage of 3gm bid for 30 days.
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  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 %). 
 
ExclusionCriteria 
Details  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 Peyronie’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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Improvement in any of the following questionnaire score.
a) International Index of Erectile function subscale A
b) International Index of Erectile function subscale B
c) Index of Premature Ejaculation 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is the improvement in the semen parameters and serum
testosterone level from baseline (day 0) after 30 days of therapy.
 		 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  		 27/01/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [garg.sahil499@gmail.com].

  6. For how long will this data be available start date provided 31-12-2023 and end date provided 12-12-2028?
    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
Modification(s)  		 Sexual health is stated as " a state of physical , emotional, mental, and social well being concerning sexuality". With the rapid pace of human development, many factors such as stress, anxiety, depression, socio-economic burden, impaired lifestyle have reported a sharp uptick year on year, especially in young adults which leads an increase in the number of cases of male sexual dysfunction.in the past two years of COVID-19 pandemic, it has been observed that the number of cases of anxiety, fear, stress have multiplied which cause sexual inefficiency. Therefore, there is a need to validate the effect of interventional modalities which enhance male sexual wellness.
In this study two groups will be formed randomly. One group will be administered Ashwagandha root powder in dosage of 3 gms bid with milk after meal and other group will be administered Roasted wheat flour in dosage of 3gms bid. The effect of both will be compared with the help of subjective and objective parameters.
 
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