| CTRI Number |
CTRI/2021/12/038493 [Registered on: 08/12/2021] Trial Registered Prospectively |
| Last Modified On: |
07/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross sectional study to find out the PostCovid complications |
|
Scientific Title of Study
|
Assessment of post COVID complications among patients attending OPD at Research and Development Wing, Govt Siddha Medical College, Arumbakkam, Chennai - 106. A Descriptive 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 |
Dr A Areeshkumar |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department of Gunapadam
Government Siddha Medical College Arumbakkam Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9789813336 |
| Fax |
|
| Email |
drareeshpoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M D Saravanadevi |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department Gunapadam
Government Siddha Medical College Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Areeshkumar |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department Gunapadam
Government Siddha Medical College Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9789813336 |
| Fax |
|
| Email |
drareeshpoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College 6 anna arch nsk nagar arumbakkam chennai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Post graduate Department of Gunapadam
Government Siddha Medical College |
| 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 Areeshkumar |
Government Siddha Medical College |
Post covid Department (outpatient) Research and developement wing 6 anna arch road nsk nagar arumbakkam chennai
Chennai
TAMIL NADU |
9789813336
drareeshpoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All sex (Male,Female)
RT-PCR postive report after 3months
|
|
| ExclusionCriteria |
| Details |
Patient who are affected in first wave before 6month |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will be beneficial for the practitioners to again knowledge about about the complications postcovid |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The present study will determine the assessment of PostCovid complications among various age group of men,women and transgender |
90days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a cross sectional study to identify the signs and symptoms of post covid complications and estimate their relative impact among various men,women and transgender attending Post Covid department, Research and developement wing, Government Siddha Medical College, Chennai.A face to face interview method will be conducted to interrogate patients with specifing questions (Structured interview method). The results of the study obtained will be beneficial for the practitioners to gain knowledge about the signs and symptoms of Post Covid Complications. |