An Open Label Single Arm Clinical Trial to evaluate the Effectiveness of Elathy Chooranam (Internal Medicine) and Sivappu Kukil Thylam (External Medicine) in the management of Kaanakadi (Urticaria) among patients reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant reduction in clinical symptoms based on Urticaria Activity Score over 7 days (UAS7) and clinical laboratory blood parameters such as IGE, AEC, ESR, CRP
研究概览
简要总结
BACKGROUND:
Urticaria is an inflammatory disorder that affects up to 20% of the world’s population at some point during their life. It is a dermal vascular reaction of the skin characterized by the appearance of pruritic wheals, elevated, pale or eruthematous, transient, and evanescent plaque lesions due to dermal edema. These lesions usually do not stay beyond 24 hours.
OBJECTIVE:
- To evaluate the changes in clinical symptoms by using urticaria activity score over 7 days.
- To evaluate the changes in clinical laboratory blood parameters such as IGE, AEC, ESR, and CRP before and after treatment.
CONDUCT OF THE STUDY:
- Study place: Interventional study
- Study design: An open clinical trial - single-arm
- Sampling method: Consecutive sampling
OUTCOME:
Significant reduction in clinical symptoms based on urticaria activity score over 7 days and clinical laboratory blood parameters such as IGE, AEC, ESR, and CRP before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with clinical symptoms of itching, burning sensation, erythema, pale pink oedematous wheal formation, wheals surrounded by flare.
排除标准
- •Evidence of any skin condition other than urticaria, angioedema, narcotic addicts, pregnancy and lactation, diabetes mellitus, hypertension.
结局指标
主要结局
Significant reduction in clinical symptoms based on Urticaria Activity Score over 7 days (UAS7) and clinical laboratory blood parameters such as IGE, AEC, ESR, CRP
时间窗: 3 Months -Screening | 12 Months - Patient enrollment | 3 Months -Outcome assessment
次要结局
未报告次要终点
研究者
Dr Shaira Banu I
National Institute of Siddha