"Comparison of Two Injection Treatments for Long-Term Unexplained Skin Allergy (Chronic Urticaria)"

Phase 2

Not yet recruiting

• Conditions: Idiopathic urticaria,

• Registration Number: CTRI/2025/06/088916
• Lead Sponsor: Dr Yeragonda Susmitha

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients greater than 18 Years of Age.
• Patients who are Diagnosed with chronic Idiopathic Urticaria.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

R L Jalappa Hospital. Sri Devaraj Urs Medical College; 🇮🇳 Kolar, KARNATAKA, India

R L Jalappa Hospital. Sri Devaraj Urs Medical College

🇮🇳Kolar, KARNATAKA, India

Dr Yeragonda susmitha

Principal investigator

8522899673

drsushmithareddy1696@gmail.com