| CTRI Number |
CTRI/2021/07/035028 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
19/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Siddha medicines in post COVID-19 patients at Sri Nallamani Siddha Covid centre, Tenkasi District, TamilNadu - A Cross Sectional Study |
|
Scientific Title of Study
|
EFFECT OF AROKYAM KIT ( SIDDHA CONVALESCENCE MEDICINES) IN PATIENTS TREATED AT SRI NALLAMANI SIDDHA COVID CARE CENTER, TENKASI DISTRICT, TAMIL NADU - A CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Rajarajeshwari |
| Designation |
Assistant medical officer Siddha |
| Affiliation |
Directorate of Indian Medicine |
| Address |
Government Hospital Kadaiyanallur Tenkasi district
Tirunelveli
TAMIL NADU
627751
India |
| Phone |
9442180895 |
| Fax |
|
| Email |
chenthurvenkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajarajeshwari |
| Designation |
Assistant medical officer SIDDHA |
| Affiliation |
Directorate of Indian Medicine |
| Address |
Government Hospital Kadaiyanallur Tenkasi district
Tirunelveli
TAMIL NADU
627751
India |
| Phone |
9442180895 |
| Fax |
|
| Email |
chenthurvenkat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Bosepriyan |
| Designation |
BSMS |
| Affiliation |
DR MGR Medical University |
| Address |
37A south street thiruthiraipoondu Thiruvarur district
Tirunelveli
TAMIL NADU
614713
India |
| Phone |
9655710656 |
| Fax |
|
| Email |
bosepriyanbp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Funding Agency, district collector Tenkasi District 627804 |
|
|
Primary Sponsor
|
| Name |
District collector Tenkasi |
| Address |
82 Railway feeder road Tenkasi district 627811 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Bosepriyan S |
Sri Nallamani Siddha COVID 19 care center |
Department of Siddha Covid care centre, Siddha, Room no 9, Sri Nallamani Siddha COVID care center
Nallamani nagar kodikurichi
Tenkasi 627804
Tirunelveli
TAMIL NADU |
9655710656
bosepriyan.bp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Siddha Medical College, Palayamkottai - 627002, Tirunelveli district |
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 |
Amukkura chooranam tablet each tablet 500mgs. |
Two tablet, Two times a day, after food, with hot water
The medicine is taken for 25 days. |
| Intervention |
Nellikai legiyam |
5 grams, two times a day, with hot water.
The medicine is taken for 15 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Post covid 19 convalescence treatment for the period of 15 days |
|
| ExclusionCriteria |
| Details |
below 12 yrs and above 85 yrs.
antenatal mothers were excluded
Malignancy conditions
Psychiatric groups |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Prevent and reduce the post COVID 19 complications |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Prevent and reduce the post COVID 19 complications |
15 days |
|
|
Target Sample Size
|
Total Sample Size="1409"
Sample Size from India="1409"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1409" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/07/2021 |
| Date of Study Completion (India) |
18/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The COVID 19 patients will be selected randomly and given the Arokiyam kit Consisting of Amukkura chooranam tablet and Nellikai legiyam for the period of 15 days for the prevention and reduction of post COVID 19 complications.
|