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CTRI Number  CTRI/2024/09/074425 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 26/06/2025
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   safety and efficacy of ashwagandha root powder in stress and anxiety in adults 
Scientific Title of Study   Single center prospective double blind randomized placebo controlled study on saftey and efficacy of a full spectrum ashwagandha root powder ghan in reducing stress and anxiety in adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Professor Pradeep Kumar Prajapati 
Designation  Vice Chancellor 
Affiliation  PGIA DSRRAU jodhpur Rajasthan 
Address  DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR
Room Number 1 Sanjeevani hospital DSRRAU JODHPUR
Jodhpur
RAJASTHAN
342001
India 
Phone  9818575845  
Fax    
Email  prajapati.pradeep1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Pradeep Kumar Prajapati 
Designation  Vice Chancellor 
Affiliation  PGIA DSRRAU jodhpur Rajasthan 
Address  DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR
Room number 1 Sanjeevani Hospital PGIA DSRRAU JODHPUR
Jodhpur
RAJASTHAN
342001
India 
Phone  9818575845  
Fax    
Email  prajapati.pradeep1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Professor Pradeep Kumar Prajapati 
Designation  Vice Chancellor 
Affiliation  PGIA DSRRAU jodhpur Rajasthan 
Address  DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR
Room number 1 Sanjeevani Hospital PGIA DSRRAU JODHPUR
Jodhpur
RAJASTHAN
342001
India 
Phone  9818575845  
Fax    
Email  prajapati.pradeep1@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurveda DSRRAU Kadwad Jodhpur 342037 
 
Primary Sponsor  
Name  Vaidya Anurag Gupta 
Address  Bright life care company BLPL Gurgaon Delhi 122001 
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 Harish singhal  Sanjeevani hospital  Room No. 1 Post Graduate Institute of Ayurveda DSRRAU JODHPUR
Jodhpur
RAJASTHAN 		 9636622206

drharish_md@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIA INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Neutral substance capsule300 mg capsule BID for 60days containing neutral substance
2Intervention ArmDrugClassical(1) Medicine Name: Aswagandha Root Powder Ghan, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  PSS Score 14 & 14+
Subjects without any psychiatric disorders  
 
ExclusionCriteria 
Details  PSS Score less than 14
Age below than 18 years and above 45 years of both sexes
Subjects having any psychiatric disorders will be excluded from the present study  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ashwagandha Root powder Ghan is found effective in reducing stress and anxiety in adults
 		 180 days 
 
Secondary Outcome  
Outcome  TimePoints 
Ashwagandha Root powder Ghan is effective in reducing stress & anxiety in adults on subjective & objective parameters after 30 day of coplition of trial  follow up period will be 30 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/10/2024 
Date of Study Completion (India) 30/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Kumar Pradeep & Gupta Prasad & Chahar Devendra & Singhal Harish & Sharma Brahmanand & Sharma Neetu & Chaudhary Bhanu & Gupta Anurag & A++, Prajapati & Govind, Prasad & Gupta,. (2025). Exploring the Therapeutic Potential of Ashwagandha (Withania Somnifera) in Alleviating Stress and Anxiety. Journal of Pharmaceutical Research International. 37. 116-126. 10.9734/jpri/2025/v37i47683. 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 [drharish_md@yahoo.co.in].

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 30-09-2029?
    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)  		 It is single center prospective double blind randomized placebo controlled study on safety and efficacy of a full spectrum ashwagandha root powder ghan in reducing stress and anxiety in adults. The trial consists of two groups: one will receive capsule containing a neutral substance and the second group will recieve Ashwagandha root powder ghan capsule of 300mg. Changes in subjective and objective parameters of stress & anxiety in adults will be the endpoint of the study.  
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