Therapeutic and Safety Evaluation of A Compound Unani Formulation along with Roghan e Zaitoon in the Management of Shara (Chronic Urticaria) A Randomized open label Comparative clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Urticaria Activity Score (UAS7)
研究概览
简要总结
Allergic diseases such as urticaria pose a major challenge in terms of diagnosis and management. Urticaria significantly affects the quality of life and is marked by wheals, redness, and itching. Acute urticaria lasts less than six weeks, while chronic urticaria persists longer, commonly affecting middle aged women. Though mast cell activation and histamine release are recognized mechanisms, the exact cause remains unclear. Modern medicine provides symptomatic relief with antihistamines, corticosteroids, and leukotriene antagonists, but these are costly, associated with side effects like drowsiness, headache, and systemic complications, and do not offer a permanent cure.
In Unani medicine, urticaria is described as Shara, attributed mainly to fasad e dam due to excess bile or abnormal phlegm. Various single and compound formulations are traditionally used with good safety and effectiveness. To evaluate this approach, a clinical study was designed using a compound Unani formulation and Roghan e Zaitoon.
The compound formulation will be administered orally in a dose of 6.125 g twice daily after meals. It consists of Faudanj (Mentha arvensis, 7 g), Tabasheer (Bambusa arundinacea, 3.5 g), Gule Surkh (Rosa damascena, 1.75 g), and Kafoor (Cinnamomum camphora, 0.25 g). Roghan e Zaitoon will be applied locally once daily after bathing. Patients will be divided into groups: one receiving both the oral compound and local application, and the other receiving Roghan e Zaitoon alone. Levocetirizine 5 mg SOS will be permitted for unbearable symptoms, and the number of tablets consumed per week will be recorded in case report forms for evaluation.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically Diagnosed patients of Chronic Urticaria.
- •Mild to moderate grade as defined by the Urticaria activity score (UAS7)
- •Patient who are willing and able to comply with scheduled visit and treatment plan, laboratory testing.
- •and other study procedure.
排除标准
- •Patients having any cardiac, renal, and or hepatic insufficiency.
- •Patient with current diagnosis of active skin disease e.g. psoriasis, lupus erythematosus Allergic dermatoses, eczema etc.
- •Pregnant and lactating women.
- •Patient unwilling to cooperate with the study protocol.
结局指标
主要结局
Urticaria Activity Score (UAS7)
时间窗: On Day 0,7,14,21 and 28.
次要结局
- DLQI (Dermatology life quality index)(On Day 0 and 28.)
研究者
Asma Md Abid
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
