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CTRI Number  CTRI/2016/06/007006 [Registered on: 06/06/2016] Trial Registered Retrospectively
Last Modified On: 26/09/2013
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy and Safety of Ashwagandha in Stress Disorders. 
Scientific Title of Study   A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ashwagandha in stress disorders 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HDC/RD/PP/2009/51 version 1.0 dt. 08/09/2009  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R M Haridas 
Designation  Professor & head of dept. of psychiatry 
Affiliation  Grant Medical College & Sir J.J. group of hospitals 
Address  Department of Psychiatry, Grant Medical College & Sir J.J. group of hospitals. Byculla, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9322843655  
Fax    
Email  maithilikadam@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pralhad Patki 
Designation  Head – Medical Services & Clinical Trials - R&D 
Affiliation  The Himalaya Drug Company 
Address  The Himalaya Drug Company, Makali, Bangalore 562123

Bangalore
KARNATAKA
562123
India 
Phone    
Fax    
Email  dr.patki@himalayahealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Pralhad Patki 
Designation  Head – Medical Services & Clinical Trials - R&D 
Affiliation  The Himalaya Drug Company 
Address  The Himalaya Drug Company, Makali, Bangalore 562123

Bangalore
KARNATAKA
562123
India 
Phone    
Fax    
Email  dr.patki@himalayahealthcare.com  
 
Source of Monetary or Material Support  
The Himalaya Drug Company Research and Development, Makali, Bangalore -562 123 
 
Primary Sponsor  
Name  The Himalaya Drug Company 
Address  The Himalaya Drug Company Research and Development, Makali, Bangalore -562 123 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dnyanraj Choudhary  Atur Sangtani, Red Cross House  Atur Sangtani, Red Cross House, 11 M.G.Road, Pune 411001
Pune
MAHARASHTRA 		 9823217423

dr.dnyanrajc@yahoo.co.in 
Dr Mathili Kadam  Grant Medical College & Sir J.J. Group of hospitals.   Dept of Psychiatry, Grant Medical College & Sir J.J. Group of hospitals, Mumbai
Mumbai
MAHARASHTRA 		 9322843655

maithilikadam@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee grant medical college and sir J J group of hospitals  Approved 
League Health Independent Ethics Committee, Thane  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stress disorders characterized by Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caplet containing Withania somnifera extract  One caplet once daily orally for 3 months 
Comparator Agent  Placebo Caplet identical in shape and size to study drug  One Caplet once daily orally for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion etc.
Age >18 years, both male and female subjects.
Hematologic and Biochemical parameters within normal limits. 
 
ExclusionCriteria 
Details  Patients with severe Psychiatric conditions.
Pregnant & Breast feeding Women.
Patients with severe Hepatic/ cardiac/ mental illness.
History of Alcohol or smoking abuse.
Patients unwilling to provide informed consent or abide by the requirements of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Ashwagandha caplets in stress disorders in
providing rapid symptomatic recovery 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of Ashwagandha caplets in stress disorders
Provide rapid symptomatic recovery
incidence of adverse events during the study period, and overall compliance to the drug treatment 		 90 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   11/05/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   All patients completed study visit. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In this Double Blind, placebo controlled, randomized study, ashwagandha extract caplets are evaluated clinically versus placebo for efficacy and safety in patients with stress disorders. Otherwise normal male/female patients above 18 years of age presenting with Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion are included in the study after obtaining informed consent. Symptoms  assessed are difficulty in concentration, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion. Assessment done on a 0-10 VAS. The overall clinical assessment is defined as cured, improved and unchanged. 
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