| CTRI Number |
CTRI/2024/10/074989 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Antihistamines ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of using antihistamines in the treatment of chronic spontaneous urticaria |
|
Scientific Title of Study
|
Comparison of efficacy of fexofenadine and levocetirizine in treatment of chronic spontaneous urticaria-A non blinded randomized control 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 Mohanraj S |
| Designation |
Post graduate student |
| Affiliation |
Government stanley medical college and hospital, chennai |
| Address |
Dept of DVL,Government stanley medical college and hospital
no 1, old jail road george town,chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
8667287393 |
| Fax |
|
| Email |
spmohan2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayabhaskar C |
| Designation |
Professor |
| Affiliation |
Government stanley medical college and hospital |
| Address |
Dept of DVL, Government stanley medical college and hospital
no 1,old jail road george town, chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9940429206 |
| Fax |
|
| Email |
buskibuski@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayabhaskar C |
| Designation |
Professor |
| Affiliation |
Government stanley medical college and hospital |
| Address |
Dept of DVL, Government stanley medical college and hospital
no 1, old jail road george town, chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9940429206 |
| Fax |
|
| Email |
buskibuski@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley medical college,1,old jail road, George town,Chennai,600001 |
|
|
Primary Sponsor
|
| Name |
DR MOHANRAJ S |
| Address |
Department of dvl
Government Stanley medical college, Chennai-1
Room no 81 |
| 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 MOHANRAJ S |
GOVERNMENT STANLEY MEDICAL COLLEGE AND HOSPITAL |
Department of dvl
Room no.81, Superspeciality block.
Chennai
TAMIL NADU |
8667287393
spmohan2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley medical college and hospital, institutional ethical committee, Chennai-1 |
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 |
Fexofenadine |
180 mg once daily orally for 3 months |
| Intervention |
Levocetirizine |
5 mg once daily orally for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age above 12 years
2) Both sexes included
3)Patients with chronic idiopathic urticaria for more than 6 weeks
4) Patients willing to give consent for study and followup
5) Patients not on any other treatment for urticaria |
|
| ExclusionCriteria |
| Details |
1)Patients with known causes of urticaria are excluded
2)Pregnant and lactating women
3)Patients with impaired renal function
4)Patients with all cardiac abnormalities
5)Patients not willing for regular followup |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing itch severity and wheals number |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete clearance of itch and wheals |
6 months |
|
|
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)
|
16/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/10/2024 |
| 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
|
After obtaining informed consent and fulfilling the inclusion criteria, patients will be randomized into two groups as group A and group B. GROUP A: Patients will receive tablet Fexofenadine 180 mg once daily in the night for 3 months GROUP B: Patients will receive tablet Levocetirizine 5 mg once daily in the night for 3 months Patients of both groups will be followed up once in 2 weeks for a total period of 3 months. Patients of both groups will undergone Baseline investigations of Complete Blood Count, Renal Function Test, Liver Function Test, Thyroid Function Test, Erythrocyte Sedimentation Rate, C- Reactive Protein, Absolute Eosinophil Count, Serum Immunoglobulin E, Electrocardiography and ENT & DENTAL opinion to rule out focal sepsis. After initial investigations each will be provided a pre-printed log to document Urticaria Activity Score. will be recorded in the followup visits and Urticaria Control Test will be recorded monthly once. |