| CTRI Number |
CTRI/2023/05/052624 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Helicobacter pylori eradication in chronic urticaria |
|
Scientific Title of Study
|
A Non blinded Randomized Controlled Trial to assess the efficacy of Helicobacter pylori eradication in patients with chronic urticaria |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology
Institute of Medical Sciences
Banaras Hindu University
Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology
Institute of Medical Sciences
Banaras Hindu University
Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Khanna |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
A-15, Brij Enclave,
Sundarpur,
Varanasi- 221005
Department of Dermatology and Venereology,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9455212536 |
| Fax |
|
| Email |
ritikakhanna119@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital,
Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005 |
| 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 |
| Prof Satyendra Kumar Singh |
Sir Sunderlal Hospital, BHU |
Room Number 207,
Dermatology Out Patient Department
Varanasi
UTTAR PRADESH |
9198120582
drsatyendraderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, IMS, BHU |
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 |
| Intervention |
Eradication kit for Helicobacter pylori |
Half of the patients who test positive for helicobacter pylori will be given tinidazole 500 mg BD + clarithromycin 250 mg BD + lansoprazole 30 mg BD for 14 days |
| Comparator Agent |
No intervention |
other group will not be given eradiation therapy for Helicobacter pylori |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All clinically diagnosed cases of chronic urticaria with a positive result in the Helicobacter pylori stool antigen test |
|
| ExclusionCriteria |
| Details |
Patients taking proton pump inhibitors/ H2 blockers/ antibiotics/ oral steroids in last 2 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Helicobacter pylori eradication in the management of chronic urticaria |
Follow up at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Successful eradication of Helicobacter pylori |
After completion of eradication therapy for 14 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
15/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients between 18 to 70 years with diagnosis of chronic urticaria coming to Dermatology OPD, Sir Sunderlal Hospital, BHU will be included in the study. Occurence of H. pylori infection in these patients will be assessed by estimating antigen for H. pylori in stool samples by ELISA based test. All H. pylori antigen positive patients will be randomized in 2 arms in 1:1 ratio with computer generated random number. Group A will be given H. pylori eradication kit ( tinidazole 500 mg BD + clarithromycin 250 mg BD + lansoprazole 30 mg BD) for 14 days with standard of care treatment for urticaria for 3 months. Group B will be given standard of care treatment for urticaria for 3 months. All antigen negative patients will be excluded from the study. All patients will be followed up for 3 months and response evaluation will be done by Urticaria Activity Score over 7 days (UAS7). |