| CTRI Number |
CTRI/2020/08/027033 [Registered on: 07/08/2020] Trial Registered Prospectively |
| Last Modified On: |
05/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
SARS-COV-2 and COVID-19 - A Randomized controlled trail (unblinded) |
|
Scientific Title of Study
|
Effectivenss of an Siddha treatment approach in SARS-COV-2 and COVID-19 - A Randomized controlled trail (Unblinded) at Govt. Kipauk Medical College, Chennai-10 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Anbu |
| Designation |
Professor, Head of the department |
| Affiliation |
Government Siddha Medical College |
| Address |
Op no 2
Department of General Medicine
Government siddha medical college
Arumbakkam
Chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Anbu |
| Designation |
Professor, Head of the department |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of General Medicine
Government siddha medical college
Arumbakkam
Chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Shiyam ranjith |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of General medicine
Government Siddha Medical College
Arumbakkam
Chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9942064861 |
| Fax |
|
| Email |
shiyam.ranchith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Kilpauk Medical College Hospital Chennai 600010 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
Op no 2 department of General Medicine government siddha medical college arumbakkam chennai 106 |
| Type of Sponsor |
Government medical college |
|
|
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 P Vasanthamani |
Govt Kilpauk Medical College Hospital |
Department of General Medicine
Govt Kilpauk Medical College Hospital
Chennai-10
Chennai
TAMIL NADU |
9942064861
gkmcdean2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
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 |
Nilavembu kudineer
Kabasura kudineer
Thippili rasayanam
Aadathodai manapagu
Swasakudori maathirai
Thoothuvalai legiyam
Amukara chooranam
Seenilnthil chooranam
Pavala parpam
Silasathu parpam
Sivanar amirtham
Muthu parpam
Gargle- with Turmeric,Thripala,Alum,Glycyrrhiza glabra,Salt |
Nilavembu kudineer-60ml bd oral administration for 14 days
kabasura kudineer-60ml bd oral administration for 14 days
thippili rasayanam- 5gm bd oral administration for 14 days
aadathodai manapagu- 5ml BD hotwater oral administration for 14 days
swasakudori maathirai-2 bd hot water oral administration for 14 days
thoothuvalai legiyam- 5gm bd with milk oral administration for 14 days
amukara chooranam-2gm bd oral administration for 14 days
seenthil chooranam -2gm bd oral administration for 14 days
pavala parpam-100mg bd oral administration for 14 days
silasathu parpam- 100mg oral administration bd for 14 days
sivanar amirtham-60g bd oral administration for 14 days
muthu parpam-100mg bd oral administration for 14 days
Gargle- with Turmeric,Thripala,Alum,Glycyrrhiza glabra,Salt |
| Comparator Agent |
tab azithromycin
Tab Hydroxychloroquinine
tab paracitamol
tab vitamin c
tab zinc
tab multivitamin
inj enoxaparin
inj methylperenidasolone
kabasura kudineer |
tab azithromycin 500mg bd oral administration
Tab Hydroxychloroquinine 200mg oral administration
tab paracitamol650mg bd oral administration
inj methylperenidasolone intravenous
inj enoxaparin intravenous
tab vitamin c oral administration
tab zinc oral administration
tab multivitamin oral administration
kabasura kudineer 60ml oral administration |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Rt-PCR positive patients, Asymptomatic patients, Fever, Dry cough, Sore throat, Difficulty in breathing |
|
| ExclusionCriteria |
| Details |
Bronchogeniccarcinoma, Pulmonary TB, Pregnancy and lactating mothers, Status asthmatics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcomes is mainly assessed by reduction in Clinical symptoms and Rt-PCR test Negative |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcomes is mainly assessed by reduction in Clinical symptoms and Rt-PCR test Negative
The outcome is assessed by patients recovery progress with faster reductions in clinical symptoms and Rt-PCR test negative,also to avoid the mortality rate by administering Allopathy and Siddha medicines for the easy recovery and saftety measures in the treatment for SARS-CoV-2 and COVID-19. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/08/2020 |
| 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
|
Not Yet published, Publication is after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the proposal of these Siddha trail medicines is to validate the therapeutic efficacy and safety profile to administer for the SARS-CoV-2 COVID-19 which has been more dreadful for the community and more challenging in treating the disease especially of severe respiratory illness which causes more severity. I entitled that this drug is very easy to collect and lesser economic in production.I concluded that this medicine will be a treasure for our Siddha system of medicine. It can be helpful in improving our Indian economy through this medicine, I hope this drug will be safe and promising drug for SARS-CoV2-COVID-19. |