| CTRI Number |
CTRI/2020/05/025298 [Registered on: 21/05/2020] Trial Registered Prospectively |
| Last Modified On: |
21/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Siddha Intervention Population Study. |
|
Scientific Title of Study
|
A prospective non-randomised open label controlled interventional study on
the e ffe ct of Siddha intervention as a prophylactic measure among high risk
population (Health Care Workers/
Containment Zone population) exposed to COVID 19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKKanakavalli |
| Designation |
Director General |
| Affiliation |
siddha central research Institute |
| Address |
Anna Hospital Campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKKanakavalli |
| Designation |
Director General |
| Affiliation |
siddha central research Institute |
| Address |
Anna Hospital Campus Arumbakkam
Anna Hospital Campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKKanakavalli |
| Designation |
Director General |
| Affiliation |
siddha central research Institute |
| Address |
Anna Hospital Campus Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| MINISTRY OF AYUSH. AYUSH BHAWAN, B-Block, GPO COMPLEX,. INA COLONY, NEW DELHI - 11-0023 |
|
|
Primary Sponsor
|
| Name |
Central council for research in Siddha |
| Address |
Central Council for research in Siddha Siddha central research institute Anna hospital campus Arumbakkam Chennai |
| Type of Sponsor |
Research institution |
|
|
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 |
| PSathiyarajeswaran |
siddha central research institute |
Departmrnt of clinical research Siddha central research Institute
Chennai
TAMIL NADU |
8754495186
p.sathiyarajeswaran@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIDDHACENTRALRESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
B972 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kabasurakudineer
Nilavembukudineer |
Siddha official formulation once daily for 14 days. |
| Comparator Agent |
Personal Sanitation and Environmental Sanitataion |
Sanitisers Handwash Masks Gloves for 6 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult Male or Female subjects above the age of 5 years to 68 years
2. Subjects who are from a community where at least 1 confirmed case is already identified.
3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
|
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating females
Known cases of uncontrolled Diabetes and Hypertension COPD or Lung related diseases
Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Subjects having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc.
5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
7. Subjects having a past history of allergy to any medicine that is part of the Siddha intervention.
8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care |
1stweek 2ndweek 3rd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of side effects non hospitalization no severe symptoms no ventilatory support no of days in ICU |
1stweek 2ndweek 3rd week and 4th week |
|
|
Target Sample Size
|
Total Sample Size="21500"
Sample Size from India="21500"
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)
|
25/05/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayush Ministry during March 2020 released an advisory to Mitigate Covid19 with AYUSH intervention Kabasurakudineer and Nilavembukudineer have been listed among prophylactics and suspected cases. AYUSH also advised all research councils to test the Intervention for their prophylactic effect. This - Non Randomised open labelled prophylactic intervention study will help to cull out the real effect of this drug. |