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CTRI Number  CTRI/2025/06/088916 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Comparison of Two Injection Treatments for Long-Term Unexplained Skin Allergy (Chronic Urticaria)" 
Scientific Title of Study   A Randomized Controlled trial of Subcutaneous Autologous Serum Therapy versus Subcutaneous Histoglobulin Injection in treatment of Idiopathic Chronic 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  Dr Yeragonda Susmitha  
Designation  Final year Dermatology 
Affiliation  Sri Devaraj URS Academy of Higher Education and Research 
Address  Room Number-03 Dermatology Final year Postgraduate Sri Devaraj URS Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563101
India 
Phone  8522899673  
Fax    
Email  drsushmithareddy1696@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yeragonda Susmitha  
Designation  Final year Dermatology 
Affiliation  Sri Devaraj URS Academy of Higher Education and Research 
Address  Room Number-03 Dermatology Final year Postgraduate Sri Devaraj URS Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563101
India 
Phone  8522899673  
Fax    
Email  drsushmithareddy1696@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yeragonda Susmitha  
Designation  Final year Dermatology 
Affiliation  Sri Devaraj URS Academy of Higher Education and Research 
Address  Room Number-03 Dermatology Final year Postgraduate Sri Devaraj URS Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563101
India 
Phone  8522899673  
Fax    
Email  drsushmithareddy1696@gmail.com  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Medical College Room Number-03 Dermatology Final year Postgraduate Sri Devaraj URS Academy of Higher Education and Research Tamaka Kolar 563101 
 
Primary Sponsor  
Name  Dr Yeragonda Susmitha 
Address  Sri Devaraj URS Academy of Higher Education and Research Tamaka kolar 563101 
Type of Sponsor  Research institution and hospital 
 
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 Yeragonda susmitha  R L Jalappa Hospital. Sri Devaraj Urs Medical College  Room Number-03 Dermatology Final year Postgraduate Sri Devaraj Urs Medical College Room Number 03 Tamaka Kolar 563101
Kolar
KARNATAKA 		 8522899673

drsushmithareddy1696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central 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  Subcutaneous Autologous Serum Therapy   Subcutaneous Autologous Serum Therapy AST Participants in this group will receive subcutaneous injections of their own serum (autologous serum) which is prepared by drawing the participants blood allowing it to clot, and centrifuging it to separate the serum. The serum is then injected into the subcutaneous tissue. The injections will be administered weekly for a period of 8 weeks. 
Comparator Agent  subcutaneous injections of histoglobulin  Participants in this group will receive subcutaneous injections of histoglobulin a commercially available preparation containing histamine and human immunoglobulin. The injections will be administered weekly for a period of 8 weeks following standard dosing guidelines for histoglobulin in chronic urticaria management. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients greater than 18 Years of Age.
Patients who are Diagnosed with chronic Idiopathic Urticaria. 
 
ExclusionCriteria 
Details  Patients who are hypersensitive to Histoglobulin or its components.
Patients will be excluded if they have an active infection.
Patients with Autoimmune diseases and Malignancy.
Pregnant and lactating females
Patients with Acute Exacerbation of Urticaria. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Efficacy of subcutaneous Autologous serum therapy(AST) versus subcutaneous Histoglobulin injection in reducing symptoms of Idiopathic chronic urticaria  Assessed at an interval of 1 week for 6 weeks and will be followed once a week for next 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2025 
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="0"
Months="4"
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  
Chronic Idiopathic Urticaria (CIU) is a challenging dermatological condition characterized by spontaneous recurrent wheals and pruritus lasting for six weeks or more significantly impacting patients quality of life.
While antihistamines remain the first-line treatment a considerable proportion of patients fail to achieve satisfactory symptom control necessitating alternative immunomodulatory therapies.
 
Subcutaneous administration offers distinct advantages including enhanced immune modulation  gradual desensitization and sustained therapeutic effects with fewer systemic side effects compared to other routes.
Despite the potential benefits of both therapies there is a lack of head-to-head comparative studies evaluating their efficacy safety and long-term benefits in CIU.
 
Given these gaps in existing research this study aims to comparatively assess the efficacy of subcutaneous Histoglobulin versus subcutaneous autologous serum therapy in patients with CIU, focusing on symptom relief recurrence rates safety profiles and overall patient outcomes.
 
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