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CTRI Number  CTRI/2016/10/007353 [Registered on: 13/10/2016] Trial Registered Retrospectively
Last Modified On: 14/08/2014
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Ashwagandha (Withania somnifera) in stress disorder 
Scientific Title of Study   Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) In Stress Disorders in Healthy Adults: A Prospective, Randomized, Double-Blind Placebo Controlled Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KSM/Stress/Ad/02/2013, version 1, dated 3rd Aug 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dnyanraj Choudhary 
Designation  Principal Investigator 
Affiliation  Atur Sangtani 
Address  Atur Sangtani, Red Cross House, 11 M.G.Road,

Pune
MAHARASHTRA
411001
India 
Phone  9823217423  
Fax    
Email  dr.dnyanrajc@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dnyanraj Choudhary 
Designation  Principal Investigator 
Affiliation  Atur Sangtani 
Address  Atur Sangtani, Red Cross House, 11 M.G.Road,


MAHARASHTRA
411001
India 
Phone  9823217423  
Fax    
Email  dr.dnyanrajc@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dnyanraj Choudhary 
Designation  Principal Investigator 
Affiliation  Atur Sangtani 
Address  Atur Sangtani, Red Cross House, 11 M.G.Road,


MAHARASHTRA
411001
India 
Phone  9823217423  
Fax    
Email  dr.dnyanrajc@yahoo.co.in  
 
Source of Monetary or Material Support  
Shri Kartikeya Pharma  
 
Primary Sponsor  
Name  Shri Kartikeya Pharma 
Address  5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (0091) 40-23204385 / 86 / 87  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Dnyanraj Choudhary  Atur Sangtani  Red cross house, consulting room No. 1, Atur sangatani,11 M.G.Road, Pune 411001.
Pune
MAHARASHTRA 
9823217423

dr.dnyanrajc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Of Chaitanya Hospital and Nursing Home, Pune for Dr. Dnyanraj Choudhary  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stress disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KSM-66 (Withania somnifera)   One capsule twice daily orally for 8 weeks  
Comparator Agent  Placebo   Placebo capsule identical to KSM 66 (Withania somnifera) but without active ingredients.One capsule twice daily orally for 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult male or female patients aged between 18 – 60 years of age
2.Patients with routine work stress
3.Patients stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc.
4.Patients with Perceived Stress Scale (PSS) score more than or equal to 20 (high stress level)
5.Body mass index between 25 and 39.9 kg/m2
 
 
ExclusionCriteria 
Details  1.Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data
2.Currently (in the past three months) attending a weight loss program
3.Underlying genetic or endocrine cause for weight gain
4.Medications known to affect weight (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications)
5.History of Alcohol or smoking abuse
6.Have clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
7.Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
8.Patients with post traumatic disorder
9.Have an established practice of meditation for three or more months
10.Pregnant and lactating women
11.Subjects with known hypersensitivity to Ashwagandha
12.Participation in other clinical trials during previous 3 months
13.Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol
 
 
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 from baseline in Perceived Stress Scale score (PSS) after 8 weeks.   8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement from baseline in the score for Oxford Happiness Scale after therapy   baseline, week 4 and week 8 
Improvement from baseline in urine cortisol level   baseline, week 4 and week 8 
Change in Weight   baseline, week 4 and week 8 
Change from baseline in vital signs  8 weeks 
Body mass index (BMI) and absolute and percentage weight loss will be compared.  8 weeks 
 
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)   25/11/2013 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is A prospective, randomized, double-blind, placebo-controlled study to compare the efficacy of Ashwagandha in stress disorder in healthy adults. A total of 50 healthy adults subjects will be recruited in this study. Adult male or female subjects between 18 to 60 years of age, with routine work stress, stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc. , Perceived Stress Scale (PSS) score more than or equal to 20 and Body mass index between 25 and 39.9 kg/m2 will be enroll in study. Study duration will be 8 weeks for each subject with baseline, week 4 & week 8 visits. Subjects were asked to take 1 capsule two times daily (total 2 capsules per day) with water daily for 8 weeks. At the end of study primary outcome will be assessed as Improvement from baseline in Perceived Stress Scale score (PSS) after therapy and secondary outcome as improvement from baseline in the score for Oxford Happiness Scale and urine cortisol level. Change in Weight, vital signs and Body mass index (BMI) and absolute and percentage weight loss will be compared after therapy.Safety will be assessed by evaluation of adverse events reported by the patients during the study and Global assessment of tolerability will be performed by physician at the end of study.

 
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