Clinical validation study to evaluate the safety and efficacy of Unani Pharmacopoeial formulation Habb-e-Filfil in Zeeq-un-Nafas (Bronchial Asthma)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- The efficacy of the study drug in the treatment of mild to moderate Zeeq un Nafas (Bronchial Asthma) will be carried out on the basis of Asthma Control Questionnaire (ACQ) and AQLQ (Asthma Quality of Life Questionnaire with standard activities)
研究概览
简要总结
This study is designed as a tri-centric open trial in patients with Zeeq-un-Nafas (Bronchial Asthma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically weekly. 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-Filfil
| **S. | |||
| No.** |
Ingredients
Botanical / Scientific Name
Quantity
|1.
Rub- us - soos
Glycyrrhiza glabra Linn.
10 gm
|2.
Filfil Siyah
Piper nigrum.
10 gm
|3.
Qand Safaid
Saccharum officinarum L.
10 gm
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild and moderate cases of Bronchial Asthma (according to The Global Initiative for Asthma Classification) presenting with at least one of the following symptoms: .Wheeze .Shortness of breath .Chest tightness and cough that vary over time and in intensity.
- •2.Participants with FEV1 between 60%-80%.
排除标准
- •Severe case of Bronchial asthma FEV1 BY less than 60%
- •known case of Interstitial lung disease.
- •known cases of chronic obstructive pulmonary disease (COPD).
- •Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
- •Participants with other Respiratory Tract Infections, tuberculosis and malignancy.
- •Patients with diseases requiring long term treatment.
- •Patients with Mental disorders affecting drug compliance.
- •8.Participants with Tobacco Smoking.
- •Pregnant and lactating females.
结局指标
主要结局
The efficacy of the study drug in the treatment of mild to moderate Zeeq un Nafas (Bronchial Asthma) will be carried out on the basis of Asthma Control Questionnaire (ACQ) and AQLQ (Asthma Quality of Life Questionnaire with standard activities)
时间窗: Weekly
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram,(LFT, KFT and Urine Examination: Routine & Microscopic.)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)