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CTRI Number  CTRI/2021/05/033857 [Registered on: 28/05/2021] Trial Registered Prospectively
Last Modified On: 30/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Antibody response after Covid-19 vaccine alongwith Kabasura Kudineer 
Scientific Title of Study   A prospective, double blind, randomized clinical study to evaluate the antibody response after Covid-19 vaccine when provided along with Kabasura Kudineer, a siddha medicine  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANJU DHAWAN 
Designation  PROFESSOR 
Affiliation  AIIMS 
Address  DEPARTMENT OF PSYCHIATRY AND NDDTC, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  9818329539  
Fax    
Email  DRANJUDHAWAN@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  ANJU DHAWAN 
Designation  PROFESSOR 
Affiliation  AIIMS 
Address  DEPARTMENT OF PSYCHIATRY AND NDDTC, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  9818329539  
Fax    
Email  DRANJUDHAWAN@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  ANJU DHAWAN 
Designation  PROFESSOR 
Affiliation  AIIMS 
Address  DEPARTMENT OF PSYCHIATRY AND NDDTC, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  9818329539  
Fax    
Email  DRANJUDHAWAN@GMAIL.COM  
 
Source of Monetary or Material Support  
Sri Sri Institute of Advance Research, Bangalore 
 
Primary Sponsor  
Name  Sri Sri Institute of Advance Research 
Address  Art of Living International Ashram 21st Km Kanakpura Road Bangalore 
Type of Sponsor  Contract research organization 
 
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 
Anju Dhawan  AIIMS New Delhi  COVID Vaccination centre, Raj kumari Amrit Kaur OPD, New building
South
DELHI 
9818329539

dranjudhawan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  normal individuals coming for COVID vaccination 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kabasura Kudineer tablet  2 tablets will be taken orally, twice a day- Morning and Night after food for 12 weeks Initiated on the day of the first dose of the vaccine  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria
-Persons without a history of SARS-CoV-2 infection
-Participants yet to receive Covid-19 vaccine.
-Residence within a 10-kilometre radius of AIIMS hospital
 
 
ExclusionCriteria 
Details  -Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or any major systemic illness
-Patients on Immuno-suppression therapy
-Pregnant Women or lactating mothers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in antibodies count following 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and at 6-8 weeks after 2nd dose.  Baseline, 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and 6-8 weeks after 2nd dose of vaccine. 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 

World over, there has been an epidemic of COVID  19 cases with unexplained low respiratory infection caused due to novel coronavirus leading to severe acute respiratory syndrome.  Because of the suddenness in outbreak, no initial recommended treatments for COVID-19 were available and clinicians, world over, have been looking for new or existing options that can help guide prevention and treatment. A vaccine   generates a level of antibodies in the body.  The body’s immune system response to the vaccine can be done by   measuring the level of antibodies it has generated in the body. 

AYUSH systems-based complementary and alternative medicine (CAM) have been traditionally used  as a treatment and preventive strategy for several diseases, including respiratory viral infections. Ministry of AYUSH   has issued an “Advisory on Coronavirus” to manage the COVID outbreak comprising of preventive and prophylactic symptom management of COVID-19   based on AYUSH systems of medicine   for immunity boosting and relieving the respiratory symptoms.   The advisory has   suggested AYUSH medicines as add on interventions to the conventional care  and have recommended multi-herbal Siddha concoction   Kaba Sura Kudineer as a symptom specific approach for prevention for fever and respiratory illness.  Its anti-inflammatory, antipyretic and antibacterial activity and its efficacy and safety  are  under study in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms

 The present project is planned to measure the immune-modulating properties of the Covaxin - Covid-19 vaccine when provided along with Kabasura Kudineer by measuring the antibody response.   

 

Using a double blind, randomized controlled trial having two arms, the experimental group A after Covaxin COVID vaccine will additionally receive Kabasura Kudineer 500 mg 2 tablets to be taken twice orally in the morning and evening after food while control group B will receive Covaxin COVID vaccine with placebo tablets.  250 Participants   using a 1:1 allocation ratio, will be  randomized into each arm.  

Antibody test levels will be measured at baseline, 4 weeks after the first dose, 4 weeks after 2nd dose and 6-8 weeks after 2nd dose 

 Primary outcome measure would be change from baseline in count of antibodies following first vaccine, second vaccine and at 6-8 weeks after 2nd dose.

  



   

 


 
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