| CTRI Number |
CTRI/2025/10/096178 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how well adding an h2 blocker works with an h1 blocker in treating chronic spontaneous urticaria |
|
Scientific Title of Study
|
Evaluation of efficacy of h2 blocker as an add on therapy with h1 blocker in chronic spontaneous urticaria patients an open label randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabanita Das |
| Designation |
Post graduate student |
| Affiliation |
Agartala government medical college and gbp hospital |
| Address |
Agartala government medical college and gbp hospital agartala west tripura
West Tripura
TRIPURA
799006
India |
| Phone |
7005775790 |
| Fax |
|
| Email |
nd366052@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Ray |
| Designation |
Professor and hod |
| Affiliation |
Agartala government medical college and gbp hospital |
| Address |
Agartala government medical college and gbp hospital department of pharmacology agartala west tripura
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Ray |
| Designation |
Prof and hod |
| Affiliation |
Agartala government medical college and gbp hospital |
| Address |
Agartala government medical college and gbp hospital department of pharmacology agartala west tripura
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agartala government medical college and gbp hospital agartala 799006 west tripura india |
|
|
Primary Sponsor
|
| Name |
Nabanita Das |
| Address |
Agartala government medical college and gbp hospital agartala west tripura |
| Type of Sponsor |
Other [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 Nabanita Das |
Agartala government medical college and gbp hospital |
Department of pharmacology fourth floor academic building
West Tripura
TRIPURA |
7005775790
nd366052@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for clinical studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L501||Idiopathic urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab levocetirizine 5mg |
Tab levocetirizine 5mg once daily for 14 days |
| Intervention |
Tab levocetirizine 5mg and tab famotidine 40 mg |
Tab levocetirizine 5mg and tab famotidine 40 mg once daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All the chronic spontaneous urticaria patients diagnosed, attending dermatology opd of a tertiary care hospital in the age group between 18 years and 70 years, recurrent attacks despite standard doses of h1 antihistamines shall be included in the study
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to h2 blockers, use of h2 blockers within the past four weeks, patients with other significant dermatological conditions, pregnancy or breastfeeding, patient not willing to participate |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urticaria activity score, urticaria control test, percentage of participants who had reduction of urticaria activity score more than 75 percent |
day 8, day 29 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatology life quality index , serum IgE level |
Day 8, day 29 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/11/2025 |
| 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
|
The present study titled evaluation of efficacy of h2 blockers as an add on therapy with h1 blocker in chronic spontaneous urticaria patients an open label randomised controlled trial shall be carried out by me principal investigator and the study shall be guided by Dr Debasis Ray Professor and hod department of Pharmacology This study aims to assess the efficacy of h2 blocker as an add on therapy to h1 blocker in a case of chronic spontaneous urticaria where histamine release is often driven by autoimmune mechanisms involving autoantibodies against IgE or its receptor leading to mast cell degranulation Diagnosis of chronic spontaneous urticaria requires history family and personal history regarding wheals and pruritus social and occupational history relation to food or drugs differential blood count ESR CRP LFT Understanding the practices related in these areas can help guide the development of targeted interventions to ultimately enhance long-term patient care outcomes The sample size has been calculated considering the proportion of subjects who showed improvement or reduction in urticaria activity score more than 75 percent after the 14 days of treatment and total sample size is 200 which has been calculated using N- master software Participants will include all patients in the age group between 18 years and 70 years based on predefined inclusion and exclusion criteria The data shall be collected in approved CRF after obtaining permission from the Institutional Ethics Committee and informed consent shall be obtained in 3 languages such as English Bengali and Kokborok Full confidentiality shall be maintained during the research period and the study shall be self-sponsored and no other outside financial help shall be required |