| CTRI Number |
CTRI/2021/06/034149 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
COVID-19 Siddha Treatment |
|
Scientific Title of Study
|
Documentation, validation and exploring the efficacy of Envagai Thervu (Eight Diagnostic Methods) COVID 19 cases – Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Jeyavenkatesh |
| Designation |
Principal Investigator |
| Affiliation |
Kokila Siddha Hospital and Research Centre, |
| Address |
Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
Kokila Siddha Hospital and Research Centre
Kunnanampatti Village
Karadikkal Post
Thirumangalam Taluk
Madurai 625706
Madurai
TAMIL NADU
625011
India |
| Phone |
914522675674 |
| Fax |
914522675674 |
| Email |
jeyyavenkateshdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Jeyavenkatesh |
| Designation |
Principal Investigator |
| Affiliation |
Kokila Siddha Hospital and Research Centre |
| Address |
Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
Kokila Siddha Hospital and Research Centre
Kunnanampatti Village
Karadikkal Post
Thirumangalam Taluk
Madurai 625706
Madurai
TAMIL NADU
625011
India |
| Phone |
914522675674 |
| Fax |
914522675674 |
| Email |
jeyyavenkateshdrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr S Senthilnathan |
| Designation |
Sr. Administrative Officer |
| Affiliation |
Kokila Siddha Hospital and Research Centre |
| Address |
Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
Kokila Siddha Hospital and Research Centre
Kunnanampatti Village
Karadikkal Post
Thirumangalam Taluk
Madurai 625706
Madurai
TAMIL NADU
625011
India |
| Phone |
914522675674 |
| Fax |
914522675674 |
| Email |
kshrcsenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr J Jeyavenkatesh
Principal Investigator
Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
|
|
|
Primary Sponsor
|
| Name |
Dr J Jeyavenkatesh |
| Address |
Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
|
| Type of Sponsor |
Other [Dr J Jeyavenkatesh] |
|
|
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 J Jeyavenkatesh |
COVID Ward, Kokila Siddha Hospital and Research Centre |
Department of Infecvtious Diseases,
COVID Ward,
Kokila Siddha Hospital and Research Centre
Kunnanampatti Village
Karadikkal Post
Thirumangalam Taluk
Madurai 625706
Madurai
TAMIL NADU |
914522675674
914522675674
jeyavenkateshdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kokila Siddha Hospital and Research Centre |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Covid Positve Patients Either RTPCR Positive Or CT Chest Confirmed Or Both. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Lactation
Spo2 Below 80
RR Above 40
PR Above 60 But Below 120
Non-Urinary Catheterized
Transgender
Known Cardiac Patients
IDDM
Hba1c Above 10
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observation of Tongue, Colour, Speech, Eyes, Skin, Stools, Urine and Pulse Diagnosis |
3 and 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical prognosis and change of pattern in Neikuri (Urine analysis by Siddha method) analysis |
DAY 7 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBSERVATION OF TONGUE, COLOUR, SPEECH, EYES, SKIN, STOOLS, URINE AND PULSE DIAGNOSIS MENTIONED IN SIDDHA TEXTS AMONG COVID POSITIVE PATIENTS TAKING TREATMENT IN KOKILA SIDDHA HOSPITAL AND RESEARCH CENTRE, MADURAI AT COVID WARD
|