| CTRI Number |
CTRI/2023/07/055278 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study Post Covid Symptoms |
|
Scientific Title of Study
|
Prevalence of Long Haul Covid In General Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Saini |
| Designation |
Post Graduate Student |
| Affiliation |
Varun Arjun Medical College and Rohilkhand hospital |
| Address |
Room Number 168,Department of Medicine, Varun Arjun Medical College and Rohilkhand hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8607434585 |
| Fax |
|
| Email |
maheshsaini33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gazanfar Ali |
| Designation |
Professor (General Medicine) |
| Affiliation |
Varun Arjun Medical College And Rohilkhand Hospital |
| Address |
Room number 167, Department of General Medicine, Varun Arjun Medical College and Rohilkhand hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9419488172 |
| Fax |
|
| Email |
maheshgazanfarmedicine@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Saini |
| Designation |
Post Graduate Student |
| Affiliation |
Varun Arjun Medical College and Rohilkhand hospital |
| Address |
Room number 168, Department of Medicine, Varun Arjun Medical College and Rohilkhand hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8607434585 |
| Fax |
|
| Email |
maheshsaini33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Mahesh Saini |
| Address |
opd room n0-44, Department of General Medicine, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India |
| Type of Sponsor |
Other [self] |
|
|
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 Mahesh Saini |
Varun Arjun Medical College and Rohilkhand Hospital |
Room number 167, Department of General Medicine, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH |
8607434585
maheshsaini33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE VARUN ARJUN MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Whoever give verbal consent for study.
2. Had covid at least 3 months prior to study.
|
|
| ExclusionCriteria |
| Details |
Having covid infection within 3 months of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the diseases prevailing in society due to long covid.
2. Information is lacking on symptoms that persist after recovery from Covid-19. We will asses persistent symptoms in patients who recoverd from COVID-19. |
2 weeks, 4 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Early diagnosis of diseases which are present in other covid 19 patients. |
2 weeks, 4 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
People with Long
COVID can have a extensive range of symptoms .Long COVID symptoms commonly
encountered are-chronic fatigueness , breathlessness , cough , headache, difficulty thinking, difficulty sleep ,altered smell ,altered taste ,menstrual irregularities, altered glycemic control ,depression, diarrhea, etc. This study aims to evaluate all intermediate and long-term
COVID-19 sequelae affecting formerly healthy adults. To determine the
diseases prevailing in society due to long covid. Early diagnosis of diseases which are present in other covid
19 patients. This will be a
single-center cross-sectional observational study among patients and general
population. This study includes anyone with confirmed/suspected covid 19.
|