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临床试验/CTRI/2025/06/088916
CTRI/2025/06/088916尚未招募2 期

A Randomized Controlled trial of Subcutaneous Autologous Serum Therapy versus Subcutaneous Histoglobulin Injection in treatment of Idiopathic Chronic Urticaria.

Dr Yeragonda Susmitha1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare the Efficacy of subcutaneous Autologous serum therapy(AST) versus subcutaneous Histoglobulin injection in reducing symptoms of Idiopathic chronic urticaria

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

To compare the Efficacy of subcutaneous Autologous serum therapy(AST) versus subcutaneous Histoglobulin injection in reducing symptoms of Idiopathic chronic urticaria

时间窗: Assessed at an interval of 1 week for 6 weeks and will be followed once a week for next 4 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Yeragonda Susmitha
申办方类型
Research institution and hospital

研究点 (1)

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