An Open Label, Randomized Clinical Trial of Unani Formulation and Autologous Serum Therapy (AST) in the management of Shara-e-Muzmin (Chronic Urticaria)
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
- UAS7- Weekly urticaria activity score[5,11]-
研究概览
简要总结
AIMS AND OBJECTIVES-
To evaluate the safety of Unani herbal formulation of Qurse Kafoor and Sharbate Nilofar in the management of Chronic Urticaria
To evaluate the efficacy of Unani herbal formulation of Qurse Kafoor and Sharbate Nilofar in the management of Chronic Urticaria.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Clinically diagnosed patients of Chronic Urticaria (Urticaria of more than 6 weeks); with clinical features of erythema, itching and wheals of any grade.
- •â€¢ Patients of either sex in the age group of 18 years onwards.
- •â€¢ Patients who have agreed to sign the written informed consent and follow the protocol.
排除标准
- •â€¢ Patients with other skin diseases like psoriasis, eczema, etc.
- •by history and examination.
- •â€¢ Patients of urticaria presenting with features of angioedema.
- •â€¢ Patients suffering from any other systemic diseases, such as HTN, DM, IHD, HIV, and bronchial asthma will be excluded on the basis of history and examination.
- •â€¢ Pregnant and lactating women.
- •â€¢ Patient already taking modern medicine or will be included in the study after a washout period of 2 weeks.
- •â€¢ In case of worsening of the symptoms, the patient will be shifted to the standard management.
结局指标
主要结局
UAS7- Weekly urticaria activity score[5,11]-
时间窗: weekly for six weeks
• Itching- 0: None, 1: Mild (no discomfort), 2: Moderate (annoying but no impact on daily activities, sleep), 3: Intense (severe itching, interferes daily activities and sleep).
时间窗: weekly for six weeks
• Wheals- 0: No wheals, 1: Mild (less than 20 wheals per 24 hours),
时间窗: weekly for six weeks
2: Moderate (20-50 wheals per 24 hours), 3: Intense (more than 50 wheals per 24 hours) or large confluent areas of wheals.
时间窗: weekly for six weeks
次要结局
- CUQ2OL- Chronic urticaria quality of life questionnaire[8,9,12]-(• Quality of life of the patient- It contains 23 questions, with scores from 1 (no complaints) to 5 (many complaints). Scores ≥ 3 are considered as poor quality of life.)
研究者
Yusra Tanveer
Department of Amraze Jild Wa Zohrawiya, Faculty of Unani Medicine