| CTRI Number |
CTRI/2024/05/067617 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on patients who are suffering with Chronic Urticaria |
|
Scientific Title of Study
|
Prospective study of quality of life,drug use,clinical outcome and side effects in patients with chronic urticaria at a tertiary medical college. |
| 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 Varinderjit Singh Kahlon |
| Designation |
PG Resident |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research
Ambala
HARYANA
133207
India |
| Phone |
7508732747 |
| Fax |
|
| Email |
vicky.kahlon50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kansal |
| Designation |
Professor and head of department |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research
Ambala
HARYANA
133207
India |
| Phone |
6239934490 |
| Fax |
|
| Email |
dinesh.kansal56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varinderjit Singh Kahlon |
| Designation |
PG Resident |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research
Ambala
HARYANA
133207
India |
| Phone |
7508732747 |
| Fax |
|
| Email |
vicky.kahlon50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research , Mullana , Ambala |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Department of Pharmacology,Maharishi Markandeshwar Institute of Medical Sciences and Research. City- Mullana, District- Ambala, State- Haryana, Country- India , Pin Code-133207
|
| Type of Sponsor |
Research institution |
|
|
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 Varinderjit Singh Kahlon |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
Room no 423 , Department of dermatology ,old building opd block
Ambala
HARYANA |
7508732747
vicky.kahlon50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of CU with duration of illness ≥ 6 weeks, age 18 years or more, male or non pregnant females/females not planning conception.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patients suffering from other types of urticaria.
Patients suffering from severe hepatic or renal insufficiency.
Pregnant or lactating females, females on hormonal contraceptives.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Persistence remission, recurrence, and pruritus |
Four weeks and eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety & Depression |
Four weeks & eight weeks |
|
|
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)
|
01/06/2024 |
| 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="0"
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
|
Day to day activities of any patient who have any form of urticaria are compromised as chronic disease have a significant effect on quality of life. Therefore, accurate clinical categorization, based on a detailed history given by the patient and a thorough examination is required to have a understanding of disease pathogenesis. The
poor outcome of disease management and high psychological impact reported by
participants support the need for a
deeper understanding of the burden of disease in these patients and more
insight in treatment options for CU . Furthermore, it is crucial to reach
affected individuals who are currently not seeking medical advice in order to
improve real-life patient care.Thus
the present study has been taken to assess quality
of life, drug use, clinical outcome and anticholinergic side effects in
patients with chronic urticaria at a tertiary medical college. |