Evaluation of efficacy of h2 blocker as an add on therapy with h1 blocker in chronic spontaneous urticaria patients an open label randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Urticaria activity score, urticaria control test, percentage of participants who had reduction of urticaria activity score more than 75 percent
研究概览
简要总结
The present study titled evaluation of efficacy of h2 blockers as an add on therapy with h1 blocker in chronic spontaneous urticaria patients an open label randomised controlled trial shall be carried out by me principal investigator and the study shall be guided by Dr Debasis Ray Professor and hod department of Pharmacology
This study aims to assess the efficacy of h2 blocker as an add on therapy to h1 blocker in a case of chronic spontaneous urticaria where histamine release is often driven by autoimmune mechanisms involving autoantibodies against IgE or its receptor leading to mast cell degranulation
Diagnosis of chronic spontaneous urticaria requires history family and personal history regarding wheals and pruritus social and occupational history relation to food or drugs differential blood count ESR CRP LFT
Understanding the practices related in these areas can help guide the development of targeted interventions to ultimately enhance long-term patient care outcomes
The sample size has been calculated considering the proportion of subjects who showed improvement or reduction in urticaria activity score more than 75 percent after the 14 days of treatment and total sample size is 200 which has been calculated using N- master software
Participants will include all patients in the age group between 18 years and 70 years based on predefined inclusion and exclusion criteria
The data shall be collected in approved CRF after obtaining permission from the Institutional Ethics Committee and informed consent shall be obtained in 3 languages such as English Bengali and Kokborok
Full confidentiality shall be maintained during the research period and the study shall be self-sponsored and no other outside financial help shall be required
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All the chronic spontaneous urticaria patients diagnosed, attending dermatology opd of a tertiary care hospital in the age group between 18 years and 70 years, recurrent attacks despite standard doses of h1 antihistamines shall be included in the study.
排除标准
- •Known hypersensitivity to h2 blockers, use of h2 blockers within the past four weeks, patients with other significant dermatological conditions, pregnancy or breastfeeding, patient not willing to participate.
结局指标
主要结局
Urticaria activity score, urticaria control test, percentage of participants who had reduction of urticaria activity score more than 75 percent
时间窗: day 8, day 29
次要结局
- Dermatology life quality index , serum IgE level(Day 8, day 29)
研究者
Nabanita Das
Agartala government medical college and gbp hospital