跳至主要内容
临床试验/CTRI/2024/02/063314
CTRI/2024/02/063314尚未招募Unknown

Comparative Evaluation of Therapeutic Efficacy of Autologous Serum Therapy versus Injection Histaglobulin in Chronic Idiopathic Urticaria: An Open-label Randomized Control Trial

AIIMS, Rishikesh1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年3月11日最近更新:
适应症

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
To compare the therapeutic efficacy of AST and injection Histaglobulin in patients of chronic idiopathic urticaria on the basis of change in Urticaria Activity Score and Dermatology Life Quality Index from baseline after 12 weeks post completion of either modality.

研究概览

简要总结

The recruitment will start after CTRI registration. Only patients of Indian ethnicity visiting Dermatology OPD AIIMS, Rishikesh for management of chronic urticaria who are willing to give consent for the study will be recruited .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 18 years or above patient willing to give consent and not having any contraindication for the procedure.

排除标准

  • Active microbial infection, Pregnancy or Lactation, Hypersensitivity to Histaglob injection, Immunosuppressed cases or uncontrolled Diabetes mellitus.

结局指标

主要结局

To compare the therapeutic efficacy of AST and injection Histaglobulin in patients of chronic idiopathic urticaria on the basis of change in Urticaria Activity Score and Dermatology Life Quality Index from baseline after 12 weeks post completion of either modality.

时间窗: At baseline, then at 10 weeks and after 12 weeks from the point of last injection given in either group

次要结局

  • To compare the reduction of antihistamine usage by patient on either of these modalities of therapy for chronic urticaria.(One year duration)

研究者

发起方
AIIMS, Rishikesh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sushantika

AIIMS, Rishikesh

研究点 (1)

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