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CTRI Number  CTRI/2019/11/021990 [Registered on: 13/11/2019] Trial Registered Prospectively
Last Modified On: 07/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To know the effect of ashwagandha root extract on cognitive function in healthy, adult stressed volunteers. 
Scientific Title of Study   A Prospective Double-Blind, Randomized, Multi-Center, Parallel-Group, Two-Arm, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Sustained Release Capsule 300 mg on Cognitive Functions in Healthy, Adult Stressed Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PRO-INV-005-19 Version 01 Dated 16 Oct 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr T S Sathyanarayana Rao 
Designation  Principal Investigator 
Affiliation  Sumana vinayaka nursing home 
Address  Psychiatry Department, OPD Division,Ground Floor, Room No:03,Sumana vinayaka nursing home,100 feet road,B.R.circle,mandya.

Mandya
KARNATAKA
571401
India 
Phone  9845282399  
Fax    
Email  tssrao19@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preethi 
Designation  Medical monitor 
Affiliation  In vitro Research solutions Pvt. Ltd, 
Address  2nd Floor, Room No: 201,In vitro Research solutions Pvt.Ltd,#22&23 Kodigehalli main road,Sahakara nagar,Hebbal, banglore

Bangalore
KARNATAKA
560092
India 
Phone  9900515364  
Fax    
Email  preethi@ivrs.org.in  
 
Details of Contact Person
Public Query  
Name  Vijay Bhaskar T 
Designation  Associate Director 
Affiliation  In vitro Research solutions Pvt. Ltd, 
Address  3rd Floor, Room No: 302,In vitro Research solutions Pvt.Ltd,#22&23 Kodigehalli main road,Sahakara nagar,Hebbal, banglore.

Bangalore
KARNATAKA
560092
India 
Phone  9741281900  
Fax    
Email  vijay@ivrs.org.in  
 
Source of Monetary or Material Support  
Inventia Healthcare Ltd, Unit 703, 704,7th floor, Hobtown Solaris, N.S.Phadke Marg, Andheri (East), Mumbai-400069, Maharashtra, India. 
 
Primary Sponsor  
Name  Inventia Healthcare Ltd  
Address  Unit 703,704,7th floor,Hubtown solaris,N.S.Phadke Marg,Andheri(east),Mumbai. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Laila Nutraceuticals  40-15-14, Brindavan Colony, Vijayawada – 520 010, Andhra Pradesh, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kumarpillai Gopu Kumar  Bengaluru Neuro Center  Neurology Department, Neurophyscology division, 2nd Floor, Room No:301,10th cross,margosa road,malleswaram
Bangalore
KARNATAKA 		 8073426671

drgopukumar@gmail.com 
Dr T S Sathyanarayana Rao  Sumana Vinayaka Nursing Home  Psychiatry Department, OPD Division,Ground Floor,Room No: 03,100 feet road,B.R Circle.
Mandya
KARNATAKA 		 9845282399

tssrao19@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Lifeline Ethics Committee  Approved 
Lifeline Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stressed Individual 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha root extract 300 mg  1 Capsule once daily after breakfast for 90 days 
Comparator Agent  Placebo  1 Capsule once daily after breakfast for 90 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Body Mass Index 18 to 29 kg/m2.
2.Healthy subjects as determined by: Medical history, Physical examination and clinical judgment of the investigator
3.Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS).
4.Cognitively sound (no cognitive impairment) subjects as identified with Montreal Cognitive Assessment (MoCA) test.
5.Subjects willing and able to provide written informed consent and agree to come for regular follow up.
6.Subject willing to comply with all study related procedures and requirements
 
 
ExclusionCriteria 
Details  1.Female subjects who are pregnant or lactating or planning to become pregnant and / or unwilling to follow standard contraception methods.
2.Post- menopausal female subjects
3.Subjects with education level below 8th grade of schooling and unable to read or understand English.
4.History of drug dependence or any severe co-morbid medical conditions.
5.History or presence of any clinically significant systemic disease including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, ophthalmologic, or any other medical condition including but not limited to uncontrolled hypertension, stroke, epilepsy, myocardial infarction, coronary artery disease, cardiac failure, type I or type II Diabetes Mellitus, renal or hepatic failure, sexually transmitted diseases (STDs),Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
7.Subjects with significant medication use including but not limited to (psychotropic, antihypertensive, beta-blockers, inhaled beta agonists, corticosteroid use within prior three months.)
8.Subjects on high alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/ Nicotine or Caffeine dependence.
9.Subjects on multivitamins/herbal supplements/ any other wellness product
10.Subject who has participated in a clinical study within the last 30 days prior to entering this study.
11.Subject with hypersensitivity to any of the ingredients of the study products.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline to the end of the study period in cognition as measured by CANTAB connect.  Day 0 & Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline to the end of the study period in:
1. Perceived Stress Scale- 10 (PSS-10) score
2. Serum Cortisol level (9-11 am)
3. Oxford Happiness Questionnaire (OHQ)
4. The Pittsburgh Sleep Quality Index (PSQI)
5. Serum Brain Derived Neurotropic Factor
6. Adverse events (AEs), frequency and severity
7. Proportion of subjects who discontinue study treatment due to adverse events
8. Changes in vital parameters and laboratory investigations (CBC, AST, ALT and Serum Creatinine)

 		 Day 0 & Day 90 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2019 
Date of Study Completion (India) 26/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Total 130 subjects will be enrolled in the study. They will be divided in to two arms.i.e active and placebo arm and followed up for 3 months. The primary objective of the study will be to assess the subtle changes in cognitive domain as measured by The Cambridge Neuropsychological Test Automated Battery (CANTAB) connect. 
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