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CTRI Number  CTRI/2025/07/091047 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [COMPARATIVE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   oral Tofacitinib compared with oral Cyclosporine A for the treatment of refractory chronic spontaneous urticaria 
Scientific Title of Study   Safety and efficacy of oral tofacitinib compared with oral cyclosporin A in cases of refractory chronic spontaneous urticaria, an open label clinical 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  Dr Bushra Iqbal Khan 
Designation  Senior Resident III 
Affiliation  Government Medical College and Hospital Nagpur 
Address  SKIN OPD 41 GMC CAMPUS Rambagh Layout Ajni Road Nagpur

Nagpur
MAHARASHTRA
440018
India 
Phone  8698812588  
Fax    
Email  dr.bushraiqbalkhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bushra Iqbal Khan 
Designation  Senior Resident III 
Affiliation  Government Medical College and Hospital Nagpur 
Address  6 Central avenue 4th Floor Qazi Building Opposite Chandralok Building Nagpur
SKIN OPD GMC CAMPUS Rambagh Layout Ajni Road Nagpur
Nagpur
MAHARASHTRA
440018
India 
Phone  8698812588  
Fax    
Email  dr.bushraiqbalkhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bushra Iqbal Khan 
Designation  Senior Resident III 
Affiliation  Government Medical College and Hospital Nagpur 
Address  SKIN OPD 41 GMC CAMPUS Rambagh Layout Ajni Road Nagpur

Nagpur
MAHARASHTRA
440018
India 
Phone  8698812588  
Fax    
Email  dr.bushraiqbalkhan@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Government Medical College Hospital 
Address  SKIN OPD RAMBAGH LAYOUT AJNI ROAD NAGPUR 
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 Bushra Iqbal Khan  GMC Nagpur  skin opd 41 rambagh layout ajni road Nagpur 440003
Nagpur
MAHARASHTRA 
8698812588

dr.bushrakhan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF PHARMACOLOGY GMC NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L509||Urticaria, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  oral cyclosporine A  dose dependent oral cyclosporine A daily for a period of maximum 6 months or till the time UAS7 equals 0 
Intervention  Oral tofacitinib  5 mg oral tofacitinib twice daily daily for a period of maximum 6 months or till the time UAS7 equals 0 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study by giving written informed consent
Patients with age ranging between 18 to 60 years having CSU upto or more than 6 months resistant to treatment after a fourfold dosage of second-generation antihistamines for upto4 weeks
Patients with UAS7 score upto or more than 16 at baseline
 
 
ExclusionCriteria 
Details  concurrent immunosuppressive use
positive autologous serum skin test
acute urticaria
specific comorbidities
or hypersensitivity to the study drugs  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
UAS7 score reduction from baseline cut-off upto or more than 16  Month 0 1 2 3 4 5 6 9 
 
Secondary Outcome  
Outcome  TimePoints 
Urticaria control test  month 0
month 9 
Dermatology Life Quality Index  month 0
month 9 
Patient Global Impression of change  month 0
month 9 
incidence and severity of any adverse events  month 0 1 2 3 4 5 6 9 
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
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)   25/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study aims to compare the efficacy and safety of oral Cyclosporin A (CsA) versus tofacitinib in managing refractory chronic spontaneous urticaria (CSU) and to evaluate patient satisfaction across treatment groups. Conducting it as a randomised, non-blind, open-label study, we will enrol male and female patients diagnosed with refractory CSU at a tertiary care centre. Patients aged 18–60 years, with persistent CSU despite fourfold second generation antihistamine therapy for up to or more than 4 weeks, will be eligible, while those with concurrent immunosuppressive use, positive autologous serum skin test, acute urticaria, specific comorbidities, or hypersensitivity to the study drugs will be excluded. Participants will be randomly assigned to receive either dose dependent CsA or 5 mg tofacitinib twice daily for up to six months or until complete symptom resolution with a post treatment monthly follow-up for 3 months.

 

Baseline assessments will include detailed demographic and clinical history, laboratory investigations, and calculation of the urticaria activity score (UAS). Treatment response will be monitored at follow-up visits (monthly), with efficacy determined by UAS7 score reduction. Patient-reported satisfaction and any adverse events will also be recorded to assess tolerability and safety. Statistical analysis will be conducted using SPSS software to compare outcomes between the two treatment groups. The study’s structured approach will yield valuable insights into the comparative effectiveness of CsA and tofacitinib, guiding personalised treatment strategies for refractory CSU. By providing objective data on efficacy, safety, and patient-reported outcomes, this research seeks to enhance therapeutic precision with clinical management optimisation in this challenging dermatologic condition, providing insights into treatment preferences.

 
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