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CTRI Number  CTRI/2020/03/024186 [Registered on: 23/03/2020] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative study of KSM-66 Ashwagandha (Withania somnifera) in Adults Experiencing High Stress and/or Anxiety 
Scientific Title of Study   Prospective, Randomized, Multi-centric, Double-Blind Placebo-Controlled Study Evaluating the Efficacy and Safety of KSM-66 Ashwagandha (Withania somnifera) in Adults Experiencing High Stress and/or Anxiety 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KSM66/PMS/2018/09 Version 3.0 dt. 21-01-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjiv Kale 
Designation  Professor and Head, Psychiatry 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Psychiatry D Y Patil Medical College and Hospital, Sector No. 5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9820547252  
Fax    
Email  sanjivkale58@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax  02227709576  
Email  deepak.langade@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax  02227709576  
Email  deepak.langade@dypatil.edu  
 
Source of Monetary or Material Support  
Shri Kartikeya Pharma Pvt Ltd 
 
Primary Sponsor  
Name  Shri Kartikeya Pharma Pvt Ltd 
Address  H.No.1057F2, PBN Center Road No. 45, Jubilee Hills, Hyderabad, Telangana 500033 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
India
Spain
United States of America  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priti Pravin Dhande   Bharati Vidyapeeth Medical College & Hospital  Bharati Vidyapeeth Medical College & Hospital, Pune-Satara Road, Dhankawadi. Pune-411043, Maharashtra.
Pune
MAHARASHTRA 		 9922426840

priti.dhande@bharatividyapeeth.edu 
Dr Santosh Ramdurg  BLDE (Deemed to be University)  B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solapur Road, Vijayapura, Karnataka 586103 Bijapur KARNATAKA
Bijapur
KARNATAKA 		 9611281386

santoshramdurg@gmail.com 
Dr B L Prajapati  CLINI-TON Multispeciality Clinic  Vinoba Vihar, Madan Gogar Marg, Model Town, Malviya Nagar.
Jaipur
RAJASTHAN 		 9314482899

prajapatilal.banwari@gmail.com 
Dr Sanjiv Kale  D Y Patil Medical College and Hospital  Department of Psychiatry D Y Patil Medical College and Hospital, Sector No. 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 9820547252

sanjivkale58@gmail.com 
Dr Ketan Pakhale  Metabol  A Metabolic Syndrome Clinic 12, Harsha Apts., Amrut Nagar Ghatkopar (west), Mumbai – 400 086
Mumbai (Suburban)
MAHARASHTRA 		 9819704302

drketan.pakhale@metabolindia.com 
Dr Prakash Khandelwal  MGM Medical College & Hospital  MGM Medical College, Room no. 301, 3rd Floor, Sector 1, Kamothe, Navi Mumbai – 410209, Maharashtra (India)
Raigarh
MAHARASHTRA 		 9822072226

drkhandelwalpn@gmail.com 
Dr Sahiba Singh  Prajakta Clinic, Ghatkopar East  Prajakta Clinic, near Police Chowk, Ambedkar Statue, Eastern Express highway, Ghatkopar East, Mumbai -400075
Mumbai
MAHARASHTRA 		 09691397711

metabolindia@gmail.com 
Dr Jaising Salve  Prakruti Care Hospital  Opp. Manisha Nagar Gate No. 1 Old Mumbai - Pune Road Kalwa
Thane
MAHARASHTRA 		 9920013944

jksalve1@gmail.com 
Dr Jignesh Prajapati  Prime Hospital  4th and 5th Floor, Sparsh Complex Near IOC Petrol Pump, Opposite Gate No. 4, Civil Hospital, Asarva, Ahmedabad 380016
Ahmadabad
GUJARAT 		 8306685983

dr.jignesh.a.prajapati@gmail.com 
Dr Sanjay Sharma  SGD Superspeciality Clinic  Swami Shri Gangadas Satsang, Near Baraf Khana, Adarsh Nagar.
Jaipur
RAJASTHAN 		 9783687308

dr.sanjaypareek81@gmail.com 
Dr Gayatri Joshi  Swasthyam Ayurvedic Chikitsalaya  Shop No. 2, Govind Bhavan Society, Dharmaveer Marg, Panchpakhadi, Thane (W)
Thane
MAHARASHTRA 		 9819648386

paranjape_gayatri@yahoo.co.in 
Dr Prerana Gupta  Teerthanker Mahaveer Medical College & Research Center  Teerthanker Mahaveer Medical College & Research Center, Teerthanker Mahaveer University, Delhi Road, Moradabad-244001, Uttar Pradesh
Moradabad
UTTAR PRADESH 		 09917943169

preranagupta1978@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
ACH Ethics Committee  Approved 
ACH Ethics Committee  Approved 
B. V. University Institutional Ethics Committee  Approved 
BLDE(Deemed to be university)  Approved 
Ethics Committee for Research on Human Subjects  Approved 
IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai  Approved 
IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai  Approved 
IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai  Approved 
IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai  Approved 
Institute Ethics Committee D Y Patil Medical College Nerul Navi Mumbai  Approved 
Institutional Ethics Committee  Approved 
National Institute of Integrative medicine  Approved 
Shrey Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha extract 300 mg (KSM66 capsule)  One capsule contains 300 mg Ashwagandha extract. One capsule to be taken orally with water two times daily for 8 weeks 
Comparator Agent  Capsule identical to study capsule  One capsule contains 300 mg Starch. One capsule to be taken orally with water two times daily for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults (male and female) aged between 18 and 65 years
2.Experiencing signs and symptoms suggestive of high stress (e.g., difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion etc.)
3.Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit
4.Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit
5.BMI between 20 and 35
6.No plan to commence new treatments over the study period
7.Non-smoker
8.Medication-free (any medications known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pill are permissible.
9.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
 
 
ExclusionCriteria 
Details  1.Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
2.Patients having total score less than 14 on HAM-A at screening.
3.Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. John’s Wort, Omega-3 etc.
4.Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
5.Patients with known post-traumatic stress disorder (PTSD)
6.Patients who have an established practice of meditation and relaxation techniques for three or more months
7.Patients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
8.Patients with history of alcohol, tobacco dependence or with any substance abuse
9.Pregnant and lactating women or suspected to be pregnant
10.Patients with known hypersensitivity to Ashwagandha
11.Patients who had participated in other clinical trials during previous 3 months
12.Patients who have 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   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score   8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in Perceived Stress Scale (PSS) score total score   4 weeks and 8 weeks 
Change from baseline in Item 1 (anxious mood) of the Hamilton Anxiety Rating Scale (HAM-A)   8 weeks 
Change from baseline in Item 2 (tension) of the (HAM-A)   8 weeks 
Remission in symptoms of anxiety and stress (Remission defined as a total HAM-A score of ≤7 at follow-up visits)  8 weeks 
Change from baseline in serum Cortisol level  8 weeks 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="700" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/04/2020 
Date of Study Completion (India) 26/04/2024 
Date of First Enrollment (Global)  16/03/2020 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This multi-centre study will compare the effects of Ashwagandha extract 600 mg/day with placebo for its effect on improvement of stress and anxiety in male and female adult individuals. The study will be conducted across 7-10 centers in India and 3-5 centres out of India.
Enrolled patients will receive one capsule of ashwagandha (300mg) or identical placebo capsule (starch 300 mg) two times daily with water for a period of 8 weeks.
Central randomization will be used for random allocation of tretament.
Efficacy outcomes are the Hamilton-Anxiety (HAM-A) scale and the Perceived Stress Scale (PSS) for anxiety and tress assessment respectively. Other efficacy outcomes will be the remission of symptoms of anxiety and stress.
Serum cortisol will be measured at baselne and 8 weeks as a measure of stress.
PSS will be assessed at baseline and then on 4 and 8 weeks. All other efficacy assessments shall be at baseline and 8 weeks.
Safety outcomes will be based on clinical safety assessed by the adverse events reported.
Clinical Global Impression (CGI) for efficacy and safety will be assessed at the end of 8 weeks

 
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