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CTRI Number  CTRI/2022/08/044636 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   To study the safety of Ashwagandha extract in healthy people  
Scientific Title of Study   An open label study to evaluate the safety and tolerability of Ashwagandha extract in healthy adult volunteers  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-10SHO0222H2-EPH11, Version 1.0 dated 2 June 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer 
Affiliation  Arjuna Natural Private Limited 
Address  Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09447818432   
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer 
Affiliation  Arjuna Natural Private Limited 
Address  Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva


KERALA
683101
India 
Phone  09447818432   
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Dr Giby Abraham 
Designation  Research Associate 
Affiliation  Arjuna Natural Private Limited 
Address  Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09288004381  
Fax    
Email  giby.a@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Private Limited, Aluva, Kerala 
 
Primary Sponsor  
Name  Arjuna Natural Private Limited 
Address  Bank Road, Aluva, Kerala, India - 683 101 
Type of Sponsor  Other [Neutraceutical company] 
 
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 Rahul Arora  Mata Roop Rani Maggo Hospital  Department of Internal Medicine, C8/C9, Om Vihar Phase Uttam Nagar, Metro Pillar 709, New Delhi-110059,INDIA
New Delhi
DELHI 		 9418050629

docrahularora@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good Society for Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Safety and tolerability of Ashwagandha extract 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha extract  One capsule of 480 mg daily for 90 days 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Males or females above 18 and below 55 years of age.
2. Individuals who have been tested negative for SARS-COV2 in a RT-PCR test.
3. Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
4. Voluntariness to participate in the trial and give signed informed consent.
5. No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations. 
 
ExclusionCriteria 
Details  1. Individuals who have been tested positive to be infected with SARS-COV2 in a RT-PCR test.
2. Patients with history of co-morbid illnesses such as cardiovascular, endocrine, renal, hepatic or other chronic disease likely to affect stress/anxiety or limit normal function.
3. Individuals with history of serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.
4. Subjects with alcohol and/or substance dependence.
5. Subjects with known allergic reactions to test drug or any of its ingredients or any other herbal supplements.
6. Undergone surgery during last one year.
7. Individuals participating in any other clinical trial.
8. Female volunteers who are found positive in Urinary Pregnancy Test or are lactating.
9. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the safety parameters from baseline to endpoint compared within-group at each timepoint  Baseline, day 30, day 60 and day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Determination of tolerability of test product by observing and assessing the occurrence of adverse
events 		 Through-out the treatment duration till last dose 
Dietary intake assessment  Baseline, day 30, day 60 and day 90 
Frequency and severity of adverse events and serious adverse events  Through-out the treatment duration till last dose 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/08/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is an open label study to assess the safety and tolerability of Ashwagandha extract in healthy adult volunteers. A total of 62 healthy volunteers will be recruited in a single arm in the study. The healthy adult subjects between 18 to 55 years who are willing to provide a written informed consent form and meeting all the  inclusion-exclusion criteria will be enrolled in study. All 62 subjects will be asked to Ashwagandha extract at dose of one capsule of 480 mg daily for 90 days with subject visits at baseline, randomization, day 30, day 60 and day 90. All the subjects will be observed for change in the safety parameters and occurrence of adverse events for product tolerability as primary outcomes of the study. AE and SAE reported by the patients will be evaluated as secondary outcomes of the study. 
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