FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/025959 [Registered on: 18/06/2020] Trial Registered Prospectively
Last Modified On: 10/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of bilastine with cetirizine or fexofenadine in chronic spontaneous urticaria 
Scientific Title of Study   Sequential comparison of bliastine with cetirizine or fexofenadine in chronic spontaneous 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 Kanika Dogar 
Designation  Post Graduate Junior resident 
Affiliation  Government Medical College and Hospital, Chandigarh  
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9888193922  
Fax    
Email  kanikadogar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Mala Bhalla 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121545  
Fax    
Email  malabhalla@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Professor Mala Bhalla 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121545  
Fax    
Email  malabhalla@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Medical College and Hospital Chandigarh 
 
Primary Sponsor  
Name  Department of Dermatology 
Address  Government Medical College and Hospital,sector 32B, Chandigarh, 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanika Dogar  Government Medical College and Hospital Chandigarh  Dermatology Venereology and leprosy OPD 4th floor B block Government Medical College and Hospital Sector 32B Chandigarh 160030
Chandigarh
CHANDIGARH 		 9888193922

kanikadogar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilastine  44 patients will be started on bilastine 20 mg OD for a period of 3 weeks to study the efficacy of the drug,followed by division into 2 groups of 22 each.22 patients will be started on cetririzine and 22 on fexofenadine for the next 3 weeks ,with each patient acting as his own control. 
Comparator Agent  Cetirizine and fexofenadine  44 patients will be started on bilastine 20 mg OD for a period of 3 weeks to study the efficacy of the drug,followed by division into 2 groups of 22 each. af 22 patients will be started on cetirizine and 22 on fexofenadine fir the next 3 weeks ,with each patient acting as his own control. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with chronic spontaneous urticaria , wheals and pruritis persiting for most of the days , for more than 6 weeks
2. patients more than 12 years of age. 
 
ExclusionCriteria 
Details  1.Patients taking systemic steroid or immunosuppressive therapy in the last 2 weeks
2. Patients with severe life threatening illness 3. Pregnant and lactating mothers. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical efficacy of bliastine in Indian population and compare its efficacy with cetirizine or fexofenadine in chronic spontaneous urticaria.  0,1,2,3,4,5,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare adverse effects of bilastine with cetirizine or fexofenadine in chronic spontaneous urticaria.  0,1,2,3,4,5,6 weeks 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   25/06/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Urticaria is a common dermatological disease. The mainstay of treatment is antihistamines. Bilastine is a newly approved drug for chronic spontaneous urticara in India in 2019. There is a paucity of studies comparing its efficacy and side effect profile with anti histamines like cetirizine and fexofenadine, especially in an Indian population. This study aims to study the efficacy of bilastine in Indian population as well as compare its efficacy with cetirizine or fexofenadine , and compare their side effect profile. 
Close