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CTRI Number  CTRI/2025/08/093234 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARING EFFICACY AND SAFETY OF CYCLOSPORINE WITH LEVOCETIRIZINE VERSUS LEVOCETIRIZINE ALONE IN CHRONIC URTICARIA 
Scientific Title of Study   A COMPARATIVE PROSPECTIVE STUDY ON THE EFFICACY AND SAFETY OF LOW DOSE CYCLOSPORINE WITH LEVOCETIRIZINE VERSUS LEVOCETIRIZINE PER SE IN CASES OF CHRONIC SPONTANEOUS URTICARIA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAKSHAM MEHTA 
Designation  JUNIOR RESIDENT 
Affiliation  SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760
OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760
Vadodara
GUJARAT
391760
India 
Phone  8107450844  
Fax    
Email  sakshammehta9120@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. RASHMI MAHAJAN 
Designation  HEAD OF DEPARTMENT AND PROFESSOR 
Affiliation  SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760
OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760

GUJARAT
391760
India 
Phone  9227676607  
Fax    
Email  rsoodmahajan@gmail.com  
 
Details of Contact Person
Public Query  
Name  SAKSHAM MEHTA 
Designation  JUNIOR RESIDENT 
Affiliation  SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760
OPD 17, DEPARTMENT OF DERMATOLOGY SUMANDEEP VIDYAPEETH, WAGHODIYA, VADODARA, GUJARAT - 391760
Vadodara
GUJARAT
391760
India 
Phone  8107450844  
Fax    
Email  sakshammehta9120@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR SAKSHAM MEHTA 
Address  OPD 17 DEPARTMENT OF DERMATOLOGY SBKS MI&RC, SUMANDEEP VIDYAPEETH WAGHODIYA, VADODARA - 391760 
Type of Sponsor  Other [SELF] 
 
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 
SAKSHAM MEHTA  DHIRAJ HOSPITAL   OPD 17, DEPARTMENT OF DERMATOLOGY, DHIRAJ HOSPITAL, SBKS MI&RC SUMANDEEP VIDYAPEETH WAGHODIYA, VADODARA, GUJARAT
Vadodara
GUJARAT 		 8107450844

sakshammehta9120@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC)  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  Cyclosporine and Levocetirizine  In this study we are going to give levocetirizine and cyclosporine to patients suffering from chronic spontaneous urticaria for study of the efficacy and safety profile of these drugs in chronic spontaneous urticaria. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients above 15 years of age will be included in the study.

Cases willing to give informed consent/ assent as the case may be.

All patients with a clinical diagnosis of chronic spontaneous urticaria for more than 6 months duration not responding to conventional lines of treatment will be included in the study.

Patients with UAS-7 score more than 16 will be included in the study. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At the end of the study, the efficacy of low dose cyclosporine with levocetirizine and of levocetirizine alone in management of chronic spontaneous urticaria will be ascertained. Further a comparison between the two modalities in terms of efficacy and safety will be better understood.  At the end of the study, the efficacy of low dose cyclosporine with levocetirizine and of levocetirizine alone in management of chronic spontaneous urticaria will be ascertained. Further a comparison between the two modalities in terms of efficacy and safety will be better understood. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/09/2025 
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 Yet Recruiting 
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   Urticaria is a heterogenous skin disorder associated with raised, well defined areas of erythema, edema and itching. It is also known as Hives. The lesions resolve spontaneously within 24 hours without any scar or residual pigmentation. Based on its duration, Urticaria can be divided into two categories: acute and chronic. Acute, which lasts less than six weeks, and Chronic, which lasts longer than six weeks. Chronic Urticaria can be further classified into chronic spontaneous urticaria and chronic inducible urticaria (triggering factors can be idiopathic, cold contact, heat exposure, vertical pressure, UV light, mechanical force, sweating, exercise). The term Chronic spontaneous urticaria refers to urticaria (hives) that occur three to four times a week, continue six weeks or longer, and have no recognized cause. It has a peak incidence between the ages of 20 and 40 years, lasting one to five years in most patients, but even longer in severe cases. Women are affected twice as often as men.
o
It can cause significant distress to the patients socially, emotionally and interfere with day-to-day activities. Various anti-histamines have been used for treating urticaria. The first-line therapy involves non- or minimally sedative second-generation antihistamine medications, the dose of which may be increased up to 4 times for those who do not respond. Combining various anti-histaminic medications is part of second-line therapy. Third-line therapy includes more recent medications such as omalizumab and cyclosporine.
o
Cyclosporine is an immunosuppressive agent which has shown to be effective in patients with chronic spontaneous urticaria not responding to regular 1st line therapy of second generation non or low sedating anti histamines. Recent studies have demonstrated a notable improvement in chronic urticaria that is not improving with first and second therapy when a low dose of cyclosporine medication (2-4 mg/kg/day) is administered for 12 weeks
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Levocetirizine is a second generation H1 blocker. It is an inverse agonist on histamine receptors. They do not easily pass through the blood–brain barrier, thereby minimizing the side effect of sedation. It acts by stabilization of mast cells. It is the 1st line drug in treatment of Chronic Urticaria. The standard dose in treatment of Chronic Urticaria is 5mg per day. It may be escalated to up to 4 times the standard dose based on the response of the patient. 
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