| CTRI Number |
CTRI/2020/06/025874 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe the effect of Siddha formulation Kabasura kudineer in COVID 19 patients |
|
Scientific Title of Study
|
A randomized open labeled clinical study to compare the effectiveness of Kabasura kudineer and Vitamin-C Zinc supplementation in the management of asymptomatic SARS-CoV-2 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Sankararaj |
| Designation |
Assistant Medical Officer Siddha |
| Affiliation |
Government Theni Medical College and Hospital |
| Address |
Siddha wing
Government Theni Medical College and Hospital
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Theni
TAMIL NADU
625531
India |
| Phone |
9965897075 |
| Fax |
|
| Email |
drsankararaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sankararaj |
| Designation |
Assistant Medical Officer Siddha |
| Affiliation |
Government Theni Medical College and Hospital |
| Address |
Siddha wing
Government Theni Medical College and Hospital
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531
Theni
TAMIL NADU
625531
India |
| Phone |
9965897075 |
| Fax |
|
| Email |
drsankararaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Anbarasi |
| Designation |
Research Officer Siddha |
| Affiliation |
Siddha Central Research Institute |
| Address |
Arignar Anna Hospital Campus
Arumbakkam
Chennai
Arignar Anna Hospital Campus
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8754416050 |
| Fax |
|
| Email |
dranbu1208@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Theni Medical College, Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 and Central Council for Research in Siddha,Arignar Anna Hospital Campus, Arumbakkam, Chennai |
|
|
Primary Sponsor
|
| Name |
Dean Government Theni Medical College |
| Address |
Government Theni Medical College
Kochi Madurai Dhanushkodi Road Theni Allinagaram Tamil Nadu 625531 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Director General |
Central Council for Research in Siddha
Ministry of AYUSH
Arumbakkam Chennai 600106 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Sankararaj |
Government Theni Medical College and Hospital |
Kochi Madurai Dhanushkodi Road Theni Allinagaram
Tamil Nadu 625531
Theni
TAMIL NADU |
9965897075
drsankararaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Theni Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kabasura kudineer |
Siddha medicine
30 – 60 ml twice daily orally |
| Comparator Agent |
Zinc and Vitamin C |
Zinc -100 mg, Vit C – 60000 IU twice daily orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Laboratory confirmed COVID-19 without symptoms
2.Consenting to participate in the study and sign the informed consent |
|
| ExclusionCriteria |
| Details |
1.Patient with co morbid conditions like DM, HT and BA.
2.Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19.
3.Pregnant and mothers those who have a pregnancy plan.
4.Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the study.
5.People who have been allergic to Siddha medicine or intolerant to taking medicine.
6.Patients participating in other COVID-19 clinical trials.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in incidence of clinical symptoms like fever, cough and breathlessness.
2.Negative conversion of SARS-CoV-2 by 14 days
3.Reduction in Viral load of SARS-CoV-2 at the end of treatment (0, 7, 14 days)
4.Examine the levels of immune markers and inflammatory markers (IgG, IgM, IgA, Th1 (TNF-Alfa, IFN-gamma, IL2) Th2 (IL6, IL10) at the end of treatment (0, 7, 14 days)
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction in incidence of complications.
2.Reduction of in hospital time.
3.Laboratory markers
4.Adverse events/effects
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
24/06/2020 |
| 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)
|
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
|
Siddha system of medicine has contributed in lowering health burden during public health emergency. It is proposed to have a good potential to combat COVID-19. One of the classical Siddha formulations is Kabasurakudineer (KSK) consists of 15 herbal ingredients. This study is proposed to observe the effect of Kabasura kudineer compared with Viamin C and Zinc supplements in asymptomatic patients with SARS CoV- 2 infection. |