| CTRI Number |
CTRI/2020/06/025763 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized controlled Clinical Trial to determine the efficacy of Siddha drugs in COVID 19 patients |
|
Scientific Title of Study
|
A Randomized controlled Clinical Trial to determine the complementary effect of selected Siddha formulations in facilitating the possibility of accelerated recovery in COVID 19 patients. |
| Trial Acronym |
SIDCOVID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenakumari R |
| 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 |
044-22381314 |
| Email |
mkumari474@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
ProfDrMMeenakshi Sundaram |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9940266442 |
| Fax |
|
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr P Shanmugapriya |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962513101 |
| Fax |
|
| Email |
sppriyaathamu@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
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof M Meenakshi Sundaram |
SRM Medical college Hospital and Research centre |
SRM Medical college Hospital and Research centre, Kaattankulathur, Chengalpattu Dt., Tamilnadu, India.
Kancheepuram
TAMIL NADU |
9940266442
mmssiddha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| SRMIST Ethics 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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Kabasura kudineer, Nilavembu kudineer, Amukra churnam, Thalisadhichurnam, Adathodai Manappagu, Brahmanada Bhairavam Pills, Thippili Rasayanam, Maldevi Chenduram, Adathodai Kudineer, Nochi Kudineer, Thirikadugu Churnam, Adathodai Manappagu and Herbal Tea
|
Thirikadugu Churnam, Adathodai Kudineer, Nochi Kudineer, Maldevi chenduram are for Moderate and Severe COVIDs and Nilavembu kudineer, Adathodai Manappagu, Brahmanada bairavam are exclusively for Mild covids |
| Comparator Agent |
Standard of Care |
Standard of Care with or without Siddha Placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Male, Female and Transgenders.
Age between 18 to 85 years
COVID 19 positive asymptomatic / pre symptomatic, mild and moderately and severely symptomatic patients.
Willing to consent to the study. |
|
| ExclusionCriteria |
| Details |
High risk groups (Patients with Complications of Diabetes, Heart diseases, Cancer and Pregnancy)
Multi organ failure Syndrome (MODS).
Patients participating in other COVID 19 trials. |
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome would be measured through Reduction of symptoms and
Recovery of patients from COVID 19 disease in a time bound manner.Conversion of RT PCR negative within first week of accelerated recovery |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Possible reduction of viral load data in subjects both at baseline and at 7 days, and 14 days or at recovery or 30 days whichever is earlier..
Number of days on treatment before recovery and Case fatality rate will also be noted.
Reduction in Signs and symptoms like Fever, cough, breathlessness, and improvement in O2 saturation (SpO2) and PaO2/FiO2 becoming 300mg/Hg in patients with severe grade and ARDS. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
17/07/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
There is a sudden outbreak of Novel Coronavirus disease all over the world. As there is no direct drug against the disease spread, it is a time needed action of usage of AYUSH drugs in management. Various drugs have been cited by AYUSH ministry and State government for management of the disease spread like Kabasura kudineer, Amukkara choornam etc. This study will be conducted based on the Preliminary analysis and literature evidence of drugs namely Kabasura kudineer, Amukkara choornam, Thalisathi choornam and Adathodai manapaggu, Maldevi chenduram, Thippili rasayanam etc. among the sample consists of 18 years and above COVID-19 – RT PCR +ve patients declared by Tamil Nadu Government accredited labs admitted to COVID 19 ward at SRMMCH / NIS or quarantined Govt. facilities or at home quarantine. The subjects will be randomly allocated to both the test or control groups. This study is carried out to analyze document scientifically the therapeutic efficacy of these drugs against Novel Corona virus disease. |