Clinical Validation of Unani Pharmocopoeial Formulation Habb-e-Hindi Zeeqi in Zeequn Nafas (Bronchial Asthma)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Improvement in sign and symptoms of Zeequn Nafas (Bronchial Asthma)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with **Zeequn Nafas (Bronchial Asthma)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Habb-e-Hindi Zeeqi
| S. No. |
Ingredients
Botanical / Chemical Name
Quantity
|1.
Beesh Mudbbar
Aconitum ferox Wall. Ex. Ser.
15gm
|2.
Post-e-Bekh-e-Madar
Calotropis procera (Ait) R. Br.
30gm
|3.
Aab-e-Adrak
Zingiber officinale Rosc
30 gm
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of 18-65 years
- •Objective evidence for reversible airway obstruction (≥12% and ≥200 mL change in FEV1 and/or a 25% and 60 L/min change in PEFR) either spontaneously or after treatment
- •Asthma for at least 6 months before enrollment.
排除标准
- •The patients of Zeeq-un-Nafas (Bronchial Asthma) with following conditions will be excluded from the study:
- •FEV1/FVC ratio < 50%
- •Pregnant and lactating mother
- •Patient with other Respiratory Tract Infections, tuberculosis and malignancy.
- •Patient with co-morbidities, Diabetes Mellitus, Hepatic and Renal Insufficiency.
- •Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
结局指标
主要结局
Improvement in sign and symptoms of Zeequn Nafas (Bronchial Asthma)
时间窗: 4 weeks
次要结局
- Haematological and biochemical assessment for safety assessment(4 weeks)