Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in urticaria activity score (UAS7) from baseline to 8 weeks
研究概览
简要总结
To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.
详细描述
To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment.
All patients will take desloratadine 10 mg at four-fold dose daily The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.
Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.
排除标准
- •other types of chronic urticaria
- •Immunocompromised patients
- •Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
- •History of Bronchial Asthma
- •Patients on anticoagulants
- •Patients on non-steroidal anti-inflammatory drugs
结局指标
主要结局
change in urticaria activity score (UAS7) from baseline to 8 weeks
时间窗: 12 months
Change in 7-day urticaria activity score (UAS7) score from baseline to 8 weeks after treatment with either AWBT with fourfold antihistamines or fourfold of antihistamines alone in Chronic Idiopathic Urticaria (CIU) patients. urticaria activity score7 ranges from 0-42. A score of 0 means complete remission while score (28-42) means severe disease
次要结局
- correlation between ASST result and treatment response(12 months)
- correlation between serum biomarkers and treatment response(12 months)
研究者
Sarah Elsayed Mahmoud Awad
Assistent lecturer
Cairo University