| CTRI Number |
CTRI/2020/06/025768 [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, Active Controlled Trial |
|
Public Title of Study
|
An open label Randomized Controlled Clinical trial 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 Clinical trial 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 MEENAKUMARI R |
| Designation |
DIRECTOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA, |
| Address |
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9176534465 |
| Fax |
|
| Email |
mkumari474@gmail.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 SANATORIUM, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Kancheepuram
TAMIL NADU
600045
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 SANATORIUM, CHENNAI - 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47
Kancheepuram
TAMIL NADU
600045
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ministry of AYUSH, New Delhi |
| National Institute of Siddha,
Tambaram Sanatorium
chennai - 47 |
| SKM Siddha and Ayurvedha Company (India) Private Limited |
|
|
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
Modification(s)
|
| Name |
Address |
| Chengalpattu Medical College Hospital |
Chengalpattu Medical College Hospital, Chengalpattu - 603001. |
| Food Safety Department District Administration |
Collectorate of Chengalpattu, Chengalpattu 603001 |
|
|
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 |
Chengalpattu Medical College Hospital |
Chengalpattu Medical College Hospital, Chengalpattu - 603001.
Kancheepuram
TAMIL NADU |
9962545930
christianvijila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Chengalpattu Medical College |
Approved |
| Instuitional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B342||Coronavirus infection, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
In Mild & Asymptomatic COVIDs
Standard of care
Kabasura Kudineer (5g) Nilavembu kudineer (5g) - 60ml tid in symptomatics & bid in
asymptomatics
Amukkura churnam 2g
Thalisathi Churnam (2g) – 4g tid with honey or milk (in diabetics)
Adathodai Manappagu 20ml bid with water
Karuppu Vishnu chakram 2 pills bd with honey
Nellikkai Leghyam 5g bid
Herbal tea with diet
For Moderate and Severe patients
Along with Standard of care,
Adathodai Kudineer (5g) Nochi Kudineer (5g) – 60ml tid
Amukkura churnam 2g Thalisathi Churnam (2g) – 4g tid with honey or milk (in diabetics)
Maldevi (Thaalaga) chenduram 100 mg bid with honey
Pavala parpam 100mg bd with honey
Thippili rasayanam 5g bid
Herbal tea with diet |
Duration Test drug will be given till clinical recovery or 30 days
whichever is earlier and the general conventional management and the Siddha convalescent advisory medicines (Nellikai legiyam, Amukkra chooranam) will be continued as deemed necessary.
Single Dose
Kudineer 10gms of drug boiled with 240ml of water will be reduced to 60 ml, filtered and consumed within
3 hours. Decoction will be freshly prepared for every dose. |
| Comparator Agent |
Reference treatment (Standard of Care) |
High flow O2 with Nasal Prongs/ Mask; O2 with C-PAP; Non Invasive ventilation; Remdesivir; Dexamethasone; Enoxaparin; Antibiotics (Azithromycin / Ceftriaxone), Zinc, Vitamin C |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Male, Female and Transgenders.
ï‚· Age between 18 to 85 years
ï‚· COVID 19 positive asymptomatic / pre symptomatic, mild, moderate and severe COVID patients.
ï‚· Willing to consent to the study. |
|
| ExclusionCriteria |
| Details |
Patients who cannot take food or drugs orally. High risk groups (Patients with Complications of Diabetes – DKA, DN, Severe Heart diseases and Pregnancy)
Patients with other severe medical conditions requiring intensive management.
Other viral pneumonia
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 with a history of positivity 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
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 Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. RT PCR conversion within first week with accelerated recovery as compared to control group |
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. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="215" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/07/2020 |
| Date of Study Completion (India) |
11/12/2020 |
| 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)
|
COVID 19 has almost entered every part of the world. Treatments proposed are ineffective or minimally effective. Hence, it is important to find drugs in appropriate time. Various Siddha drugs are proposed by the Siddha fraternity to combat COVID 19 disease after analyzing its nature. They are to be analyzed and proven clinically through this study.
|