| CTRI Number |
CTRI/2020/06/025762 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to
Evaluate the Safety and Efficacy of selected Siddha formulations in patients
diagnosed with COVID-19 |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to
Evaluate the Safety and Efficacy of selected Siddha formulations in patients
diagnosed with 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 |
mkumari474@yahoo.com |
|
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 sanatoriuN
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 sanatoriuN
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, Tambaram 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 |
| Dr G J Christian |
National Institute of Siddha & other Govt . approved COVID facilities and Quarantined houses |
national institute of siddha
tambaram sanatorium
Kancheepuram
TAMIL NADU |
9962545930
christianvijila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| 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; Amukkara choornam; Nelikai legiyum |
KS kudineer will be administered twice a day in
asymptomatic COVID patients; and will
be administered thrice a day in symptomatic
individuals just before or after food. Apart from this medication, Convalescent medication is prescribed namely Amukkara choornam 2gms bid and Nellikkai ilagam 5gms bid for 15 days. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ï‚· Male, Female and Transgenders.
ï‚· Age between 18 to 85 years
ï‚· COVID 19 positive asymptomatic / pre symptomatic, mild and moderately symptomatic patients.
ï‚· Willing to consent to the study. |
|
| ExclusionCriteria |
| Details |
Patients who have received organ transplantation in the past 6 months or planning surgery.Patients with severe or critical covid-19 infections.Patients with any active malignancy. Patients who have severe underlying diseases that affects survival, including blood diseases,dyscrasia, active bleeding, severe malnutrition, etc.
Patients with allergic constitution, or patients allergic to investigational products
Patients positive for HIV, Hepatitis B and Hepatitis C at screening.Critical patients with life expectancy <48 hours. Septicemia / Multi organ failure Syndrome (MODS).Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.Patients participating in other COVID 19 trials. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome would be measured through Reduction of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Possible reduction of viral load data in subsets of both groups both at baseline and at 7 days, and14 days or at recovery or 30 days whichever is earlier..
ï‚· Sub group analysis for male, female and Age groups will also be studied in each group. Number of days on treatment before recovery and case fatality rate if any will be documented.Reduction in Signs and symptoms like Fever, cough, breathlessness, and improvement in O2 saturation (SpO2) and PaO2/FiO2 |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
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="6"
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 is a sudden outbreak of Novel Coronavirus disease all over the world, there is no proven drug against the disease spread. Preliminary clinical experience with few Siddha drugs have shown their therapeutic efficacy against Novel coronavirus with clearance of SARS-CoV -2 virus from the system within 3 days of administering Siddha regimen as confirmed with qualitative RT-PCR . To scientifically validate the preliminary experience an open label randomized controlled trail will be conducted with two groups with a sample size of 200. The results of the study when generalized will help containing the pandemic. |