| CTRI Number |
CTRI/2020/06/025761 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Population based cross sectional study for COVID 19 prophylaxis with
Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non
containment zones during 2020 pandemic in Tamil Nadu, South India |
|
Scientific Title of Study
|
Population based cross sectional study for COVID 19 prophylaxis with
Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non
containment zones during 2020 pandemic in Tamil Nadu, South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Meenakumari |
| Designation |
Director |
| Affiliation |
National institute of Siddha |
| Address |
National institute of siddha
tambaram sanatorium
National institute of siddha
tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9176534465 |
| Fax |
|
| Email |
nischennaisiddha@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Head of the Department , department of Noi Naadal |
| Affiliation |
National institute of Siddha |
| Address |
national institute of siddha
tambaram sanatorium
national institute of siddha
tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G J Christian |
| Designation |
Head of the Department , department of Noi Naadal |
| Affiliation |
National institute of Siddha |
| Address |
national institute of siddha
tambaram sanatorium
national institute of siddha
tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Siddha, Tmbaram Sanatorium, chennai - 47. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National institute of Siddha,
Tambaram Sanatorium, Chennai - 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Christian G J |
Tambaram Taluk |
Mudichur, Rajakilpakkam, Hastinapuram, Pammal , Tambaram
Kancheepuram
TAMIL NADU |
9962545930
christianvijila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instuitional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID Prophylaxis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Laboratory confirmed COVID-19 with or without symptoms
b) Those who are to be excluded in the study, as evaluated by the investigators.
c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP
certified pharma companies.
7
d) Persons with poor drug compliance |
|
| ExclusionCriteria |
| Details |
a) Laboratory confirmed COVID-19 with or without symptoms
b) Those who are to be excluded in the study, as evaluated by the investigators.
c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP
certified pharma companies.
7
d) Persons with poor drug compliance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COVID-19 Test Positivity / Negativity upto 31 days follow up. |
COVID-19 Test Positivity / Negativity upto 31 days follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General and specific health status as described above.
Immune Status and Function as assessed by ISQ |
3 months |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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)
|
15/06/2020 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
As there was a sudden pandemic outbreak of Novel Corona virus disease all over the World, various herbal remedies have been suggested by the AYUSH ministry and the state government of Tamilnadu for prophylaxis. In need to document the various herbal remedies along with Kabasura kudineer and Nilavembu kudineer in various containment zones and Non- containment zones a questionairre based population study survey will be conducted.
|