| CTRI Number |
CTRI/2020/06/025769 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
13/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A prophylactic interventional study to determine the possible protective effect of Siddha Polyherbal formulation Kabasura Kudineer against the COVID 19 on
intermittent, month-long consumption by public with close contacts to COVID patients and frontline workers in Tamil Nadu, India |
Scientific Title of Study
Modification(s)
|
A prospective Non randomized open label controlled intervention study on the effect of Polyherbal Siddha formulation Kabasura kudineer 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 |
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
Modification(s)
|
| Name |
Dr K Suresh |
| Designation |
Associate professor, Department of Kuzhandhai maruthuvam |
| Affiliation |
National institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr N J Muthukumar |
| Designation |
Head of the department , Department of Sirappu maruthuvam |
| Affiliation |
National institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
National Institute of siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
|
| Email |
njmuthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium, chennai - 47 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha Ministry of AYUSH |
| 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
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Suresh |
National Institute of Siddha |
GST Road Tambaram Sanatorium chennai 47
Kancheepuram
TAMIL NADU |
9962571137
drsureshherbal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Highrisk population and frontline workers of COVID19 Pandemic |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Kabasura kudineer |
5- 10gms of Kabasura kudineer drug boiled with 240ml of
water will be reduced to 60 ml, filtered and
Consumed within 3 hours. Concoction will
be freshly prepared for every dose.
Time of Administration: This dose will be administered once a day just before or after food. |
| Comparator Agent |
Standard of Care |
General public and frontline workers who have taken/given Allopathic Standard of Care like Vitamins and/or other drugs for Covid prevention. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the willing frontline health workers, police personnel and other public servants inclusive of those with direct / primary contacts with COVID positives (High risk and moderate risk exposures). |
|
| ExclusionCriteria |
| Details |
Not willing to sign informed consent.
Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of participants protected during the outbreak of COVID 19 compared between the Kabasura Kudineer taken and Standard of Care taken groups |
Assessment will be done at Baseline and 30th day from the start of Prophylactic intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General and specific health status as assessed.
❑ Immune Status and Function as assessed by ISQ
❑ Progression of disease in the participants who turned COVID 19 positive |
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="40000"
Sample Size from India="40000"
Final Enrollment numbers achieved (Total)= "20462"
Final Enrollment numbers achieved (India)="20462" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
As there is a sudden outbreak of Novel coronavirus all over the world there is a need of drug to prevent the COVID infection from direct contact persons who are in high , moderate,Low risks of the disease. To document the prophylatic efficacy of the drug Kabasura kudineer among the high risk population, Moderate risk and low risk frontline workers. This study will be conducted as Non randomized study among the high, moderate and low risk frontline workers in Tamil nadu. |