| CTRI Number |
CTRI/2020/05/025215 [Registered on: 16/05/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of Mild COVID 19 patients. |
|
Scientific Title of Study
|
A prospective, single centre, randomized open labelled comparative clinical study to evaluate the effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of asymptomatic COVID 19 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 S Natarajan |
| Designation |
Head, Department of Clinical Research |
| Affiliation |
Siddha Central Research Institute |
| Address |
Arignar Anna Hosiptal Campus
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
drnatarajan78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Natarajan |
| Designation |
Head, Department of Clinical Research |
| Affiliation |
Siddha Central Research Institute |
| Address |
Arignar Anna Hospital Campus
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
drnatarajan78@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
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
dranbu1208@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical College,No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001 |
|
|
Primary Sponsor
|
| Name |
Dean |
| Address |
Government Stanley Medical College, No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Siddha |
Arumbakkam, Chennai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Natarajan |
Government Stanley Medical College |
101,F Block, COVID Division, Department of Medicine, No. 1, Old Jail Rd, George Town, Chennai, Tamil Nadu 600001
Chennai
TAMIL NADU |
9843086050
drnatarajan78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley Medical College |
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 |
60 ml bd for 14 days |
| Comparator Agent |
Vitamin C, Zinc supplementation |
Vitamin C - 60000IU OD for 14 days
Zinc supplementation - 100mg od for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 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, 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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in incidence of clinical symptoms of COVID 19
Negative conversion of SARS-CoV-2
Reduction in Viral load of SARS-CoV-2 at the end of treatment
Examine the levels immune markers and inflammatory markers |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of in hospital time
adverse events/effects
Siddha Udaliyal assessment
Siddha Uyir thathukkal and udal thathukkal assessment |
14 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/05/2020 |
| Date of Study Completion (India) |
15/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Coronavirus
disease 2019 (COVID-19) is a respiratory tract infection caused by a newly
emergent coronavirus, SARS-CoV-2, that was first recognized in Wuhan, China, in
December 2019. While most people with COVID-19 develop mild or uncomplicated
illness, approximately 14% develop severe disease requiring hospitalization and
oxygen support and 5% require admission to an intensive care unit.
At
present, there is limited evidence from randomized clinical trials to support
any vaccines or pharmacological treatments from conventional medicine for
COVID-19.
According
to Siddha system of medicine, the symptoms and signs of COVID-19 are identified
as the aggravation of Iyam and which
later associated with other Uyir thathukkal Vali and Azhal and expressed as
Thontham (Mukkutram) leads to sanni.
In
this context, one of the classical formulations from Siddha system of medicine
is Kabasura kudineer (KSK) consists of 15 herbals ingredients which
individually has anti-viral activity
has been recommended for the prophylaxis and management of COVID 19.
Vitamin
c and zinc supplementation(CZ) is being prescribed for the COVID19 positive
asymptomatic patients admitted in isolation ward. The role of CZ in the
management of COVID19 is still not clear. Therefore, study will compare the
effect of KSK and CZ in terms of negative conversion of SARS CoV- 2 infection.
|