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CTRI Number  CTRI/2020/07/026820 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 26/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Curcumin for COVID-19 Pre Exposure Prophylaxis  
Scientific Title of Study   Curcumin for COVID-19 Pre Exposure Prophylaxis: A Randomised Controlled Trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh .

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh .

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh .

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Rishikesh , Virbhadra Road , Barrage , Dehradun , Uttarakhand , India . Pin 249203 
 
Primary Sponsor  
Name  Rohit Walia  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science Rishikesh  
Type of Sponsor  Other [Principal investigator ] 
 
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 
Rohit Walia   All India Institute of Medical Science Rishikesh   Room number , Department of Cardiology , All India Institute of Medical Science Rishikesh
Dehradun
UTTARANCHAL 		 8800492549

rwalia7731@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  people at risk of COVID infection - health care workers , diabetes , cardiac patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcumin   Oral Curcumin capsule 500 mg twice daily (morning , evening ) for 12 weeks  
Comparator Agent  Placebo   Placebo Capsule oral twice daily morning evening for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  People at risk of SARS-CoV 2 infection ( healthcare professionals , attendants of COVID patients , non COVID patients admitted in hospitals or his risk groups like elderly , cardiovascular patients , diabetes , obesity )
Not having a previous COVID19 diagnosis
Not having experienced COVID19 symptoms since 30 th Jan 2020.
Not having taken any pre-exposure prophylaxis ( HCQ , any other medication or Ayurvedic preparation or food supplement )
Having a negative SARS-CoV 2 test before randomisation 
 
ExclusionCriteria 
Details  Any chronic infection
Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis
Known history of hypersensitivity to the study drug or any of its components
Immune suppressant drugs
Recent vaccination within 2 month
Pregnancy
Primary Immunodeficiency states • Anemia
Leukopenia
Thrombocytopenia
Co morbidities precluding survival required for duration of study follow up
 
 
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 
1. SARS-CoV 2 infection rate Using RTPCR  12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of respiratory tract infections during course of study using the Wisconsin Upper Respiratory Symptom Survey
 		 12 weeks 
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.   12 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 4 
Date of First Enrollment (India)   09/08/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Curcumin has been proven to have anti viral , anti bacterial and anti inflammatory properties and immunomodulator. We plan to a randomised controlled trail to study curcumin as pre exposure prophylaxis in healthcare workers and high risk groups and look for Covid infection rates over a period of 12 weeks and look for COVID positivity rates over a period of 12 weeks between cur cumin vs. placebo.   
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