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CTRI Number  CTRI/2018/07/014792 [Registered on: 10/07/2018] Trial Registered Prospectively
Last Modified On: 27/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Ashwagandha on the Immunity of Healthy Participants  
Scientific Title of Study   A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension to Assess the Immunomodulatory Effects of Ashwagandha (Withania Somnifera) Extract on Healthy Participants 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-05ASH 0617H3-EPH07 Version:01 Date: May 4, 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla  
Designation  DGM, Research and Development  
Affiliation  Arjuna Natural Ltd (Formerly Arjuna Natural Extracts Ltd) 
Address  Arjuna Natural Ltd, Bank Road, Aluva,

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla  
Designation  DGM, Research and Development  
Affiliation  Arjuna Natural Ltd (Formerly Arjuna Natural Extracts Ltd) 
Address  Arjuna Natural Ltd, Bank Road, Aluva,

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Dr Binu T Kuruvilla  
Designation  DGM, Research and Development  
Affiliation  Arjuna Natural Ltd (Formerly Arjuna Natural Extracts Ltd) 
Address  Arjuna Natural Ltd, Bank Road, Aluva,

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Ltd (Formerly Arjuna Natural Extracts Ltd), Aluva 
 
Primary Sponsor  
Name  Arjuna Natural Ltd  
Address  Bank Road, Aluva - 683101 
Type of Sponsor  Other [Neutraceutical Industry] 
 
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 Himanshu Shukla  PGH Hospital  Department of Medicine, B-107, Rajan Enclave, Vikas Nagar, Uttam Nagar, Hastsal- 110059.
West
DELHI 		 09999461089

himanshu502000@yahoo.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
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Immunomodulation 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo (Sucrose)  Identically colored and similar sized placebo capsules. Dose - 1 capsule of placebo once daily before breakfast. Study period - 30 days of intake. Extension period - No placebo used.  
Intervention  Shoden®(Withania somnifera extract)   Shoden® 180 mg containing 21mg glycowithanolides. Dose - 1 capsule of Shoden® once daily before breakfast. Study period - 30 days intake Extension period - 30 days intake. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  72.00 Year(s)
Gender  Both 
Details  1. BMI <30.0
2. Healthy participants (health status confirmed by clinical history , Physical Exam and routine blood analysis)
3. The participant must not have taken any vitamin / mineral/ dietary or herbal supplements 1 month prior to enrolling in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
4. Participant must be able, willing and likely to fully comply with study procedures and restrictions.
5. Participant willing to sign the informed consent
 
 
ExclusionCriteria 
Details  1. Participant suffering from different diseases/disorders and/or having any kind of allergy.
2. Participant with or having prior history of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
3. BMI > 30.0
4. Pregnant/lactating women
5. Undergone surgery during last one year.
6. Received organ transplantation.
7. Chronic smokers.
8. Alcohol or drug abuse
9. Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
10. Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.
11. Participants with known hypersensitivity to test drug.
 
 
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 
1. Change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), between groups.
2. Change in baseline values of Immunoglobulin (IgG, IgM and IgA) levels between groups
3. Change in Baseline counts of T- cell (CD3+, CD4+, CD8+), B-cell (CD19+), and NK-cells (CD16+,CD56+) between groups. 		 Baseline, Day 30, Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
1. Within the group comparison for the change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), Immunoglobulin (IgG, IgM and IgA) and TBNK cell counts.
2. Comparison of the change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), Immunoglobulin (IgG, IgM and IgA), and TBNK cell count levels
3. Change in Baseline value (Day 0) of Serum cortisol  		 1. Baseline, Day 30, Day 60 for intervention.
2. baseline to day 30 of placebo group and baseline (day 30) to day 60 of the crossover group.
3. Baseline, day 30, day 60. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/07/2018 
Date of Study Completion (India) 07/12/2018 
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
Modification(s)  		 Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 01-12-2021 and end date provided 02-12-2024?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, placebo controlled, double blinded study to evaluate the immunomodulatory effects of ashwagandha on healthy participants aged 45 to 72 years. There will be a total of 24 participants both males and females. The double blinded study is for a period of 30 days. After that all the participants will be given ashwagandha in an open label extension study for 30 days. This study will evaluate the change in cytokine, immunoglobulins, and total T-cells, B-cells, and NK-cells from baseline to end of the study.  
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