| 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
|
|
|
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
|
|
|
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 |
|
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. |