| CTRI Number |
CTRI/2024/06/068911 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of quality of life in patients of chronic urticaria |
|
Scientific Title of Study
|
Evaluation of quality of life in patients of chronic urticaria : A cross sectional study |
| 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 Rifat Siddiqui |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital, Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997312776 |
| Fax |
|
| Email |
rifatsiddiqui0786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Rathore |
| Designation |
Professor and Head Of Department (Dermatology, Venereology and Leprosy |
| Affiliation |
Rohilkhand Medical College and Hospital, Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9412332063 |
| Fax |
|
| Email |
drpraveenderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rifat Siddiqui |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital, Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997312776 |
| Fax |
|
| Email |
rifatsiddiqui0786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India, 243006 |
|
|
Primary Sponsor
|
| Name |
Dr Rifat Siddiqui |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh |
| Type of Sponsor |
Private 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 Rifat Siddiqui |
Rohilkhand Medical College and Hospital, Bareilly |
Opd Room number 1197, Dermatology OPD
Bareilly
UTTAR PRADESH |
9997312776
rifatsiddiqui0786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, (2) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written consent
Patients of both genders aged over 18 years
Patients with chronic urticaria defined as urticarial eruption of more than 6 weeks duration characterised by hives or wheals
Free from any other chronic illness, systemic disease and patients with normal psyche |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with acute urticaria, contact urticaria, urticarial vasculitis, angioedema with no urticaria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects of Chronic Urticaria on patient’s physical and mental well being. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
24/06/2024 |
| 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) |
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
|
Chronic urticaria is a common disease in Indian population and significantly affects patient’s physical as well as mental well being. Chronic urticaria is defined as urticarial eruption of more than 6 weeks characterised by hives or wheals. All patients of chronic urticaria coming in the OPD will be the sampling frame from which sample will be chosen by applying inclusion and exclusion criteria. They will be counselled and an informed consent will be taken. All the study subjects will be administered questionnaires after explaining the purpose of the study. The data will be collected through questionnaire tool. |