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CTRI Number  CTRI/2023/07/054711 [Registered on: 04/07/2023] Trial Registered Prospectively
Last Modified On: 08/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Ashwagandha in patients with stress and anxiety having cardiovascular comorbidities. 
Scientific Title of Study   A randomized, double-blind, two-arm, placebo-controlled Phase III clinical study to assess the safety and efficacy of Ashwagandha extract in patients with stress and anxiety having cardiovascular comorbidities. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: WSI/ASWG/23/01 Version 1.0 Dated 10/03/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amrit Pattojoshi 
Designation  Professor and HOD Department of Psychiatry 
Affiliation  Hi-Tech Medical College and Hospital 
Address  Hi-Tech Medical College and Hospital Health Park Pandra Rasulgarh Bhubaneswar Odisha India

Khordha
ORISSA
751025
India 
Phone  9438148100  
Fax    
Email  dramritp@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Valavan 
Designation  Head Scientific and Medical Affairs 
Affiliation  Dr. Willmar Schwabe India Pvt. Ltd. 
Address  Dr. Willmar Schwabe India Pvt. Ltd. A 36 Sector 60 Noida India

Gautam Buddha Nagar
UTTAR PRADESH
201304
India 
Phone  91-9312309186  
Fax    
Email  care@schwabeindia.com  
 
Details of Contact Person
Public Query  
Name  Sudeep Kumar Patra 
Designation  Consultant and Head Clinical Operations 
Affiliation  Indivirtus Healthcare Services Pvt. Ltd. 
Address  Indivirtus Healthcare Services Pvt. Ltd. 521-522 2nd Floor TDI City Taj Plaza Sector 118 Mohali Punjab India

Chandigarh
CHANDIGARH
160059
India 
Phone  91-9861268508  
Fax    
Email  spsudeepppatra@gmail.com  
 
Source of Monetary or Material Support  
Hi-Tech Medical College and Hospital Health Park Pandra Rasulgarh Bhubaneswar Odisha India 
 
Primary Sponsor  
Name  Dr. Willmar Schwabe India Pvt. Ltd 
Address  A-36, Sector 60, Noida, Uttar Pradesh, India. Pin-201304 
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 Amrit Pattojoshi  Hi-Tech Medical College and Hospital  Hi-Tech Medical College and Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar, Pin-751025, Odisha, India
Khordha
ORISSA 		 91-9438148100

dramritp@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee, Hi-Tech Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha  300 mg twice a day after meals 
Comparator Agent  Placebo  300 mg twice a day after meals for a period of 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female subjects ≥18 and ≤ 65 years old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ - SF)
People who have a history or clinical diagnosis of a pre-existing hypertension
BMI of ≥ 18 - ≤ 34.9 kg/m2
Having at least three of the following five metabolic risk factors:
i. Waist circumference > 94 cm (40 inches) for men and > 80 cm (35 inches) for women
ii. Fasting triglycerides > 150 mg/dL
iii. Blood pressure ≥130 mm Hg (Systolic Blood Pressure)
and/or ≥85 mm Hg (Diastolic Blood Pressure)
iv. Fasting blood glucose ≥ 100 mg/ dl
v. Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women)
HAM-A total score ≥ 18
GAD ≥ 5
All participants will be encouraged to not make any major lifestyle changes during the study period.
They will be informed that any major changes may result in exclusion from the study.
Participants willing to provide written informed consent. 
 
ExclusionCriteria 
Details  History of myocardial infarction since 1 year.
Heart failure symptoms greater than New York Heart Association Functional Class II.
Hemodynamically significant valvular or left ventricular (LV)
tract obstruction.
Subjects without a pacemaker and with any of the following:
i. Sinus bradycardia (< 50 bpm)
ii. Sick sinus syndrome
iii. Atrioventricular block of more than 1st degree
Syncopal episodes presumed to be due to uncontrolled life threatening arrhythmias.
Planned cardiac surgery or coronary angioplasty within 6 months of screening.
History of recent non-haemorrhagic stroke or transient ischemic attack (TIA), history of haemorrhagic stroke.
Hyperthyroidism.
Known chronic liver disease or end stage renal disease.
Severe, symptomatic benign prostatic hyperplasia which may require surgery.
Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain or any other anxiolytic agents.
Treated hypertension stabilized for less than 3 months.
Morbid obesity (BMI > 40 Kg/m2).
Subjects with a blood pressure range of systolic ≥ 180 mm Hg and diastolic ≥ 120 mm Hg.
Nursing or pregnant women 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the impact of the Investigational Product (IP) on stress levels by using the Hamilton Anxiety Rating Scale  Day 30 and Day 60 from the baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of the IP onUnspecified Anxiety Disorder (DSM-5
300.00; ICD-10 F41.9 resp. ICD-11 6B0Z) along with following
cardiovascular comorbidities’ parameters.
Lipid Profile
Electrocardiogram
Mental alertness of the participants using a three-pointer scale
after rising
Blood Pressure
Fatigue using the Fatigue Severity Scale (FSS)
 		 Day 30 and Day 60 from the baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/07/2023 
Date of Study Completion (India) 19/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The purposed study is a Phase III, randomized, double-blind, two-arm, placebo-controlled clinical study to assess the safety and efficacy of Ashwagandha extract in patients with stress and anxiety having cardiovascular comorbidities. The study is proposed to be conducted at single site in India to recruit approximately 60 number of patients to meet the objective of this study. Primary outcome of this study is to assess the impact of the Investigational Product on stress levels by using the Hamilton Anxiety Rating Scale  and secondary outcome is to assess the impact of the Investigational Product on Unspecified Anxiety Disorder along with cardiovascular comorbidities. 
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