Efficacy of Habb-e-Zeequn Nafas versus inhaler (Budesonide-formoterol DPI) in Bronchial Asthma: A randomized controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement in FEV1, FEV1/FVC ratio, PEF assessed by Spirometry
研究概览
简要总结
42 diagnosed cases of Bronchial Asthmawill be included in the study. Subjects will be randomly allocated into two equal groups. Written informed consent will be obtained from them. In test group, research drug (53mg) will be given in tablet form daily for 30 days. In the control group, control inhaler will be advised according to GINA guidelines. Patients will be followed at 15th and 30th day. Patient Between the age group 18-50 years of All genders, diagnosed with Bronchial Asthma of mild (FEV1 more than 70%) to moderate severity (FEV1 60-69%).
Main Outcome Measures:
Primary outcome:
· Improvement in FEV1, FEV1/FVC ratio in response to the treatment.
Secondary outcome:
Improvement in ACT (Asthma Control Test) score in response to the treatment.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18-50 years.
- •All gender.
- •Bronchial asthma of mild (FEV1 more than 70%) to moderate severity (FEV1 60-69%) of predicted.
- •Patients ready to give consent for the study.
排除标准
- •Patients below 18 and above 50 years of age.
- •FEV1 less than 60% of predicted in spirometry.
- •Patients with systemic illness such as HTN, IHD, DM, Thyroid disorders, etc.
- •Patients with a history of allergic rhinitis, emphysema, chronic bronchitis, pneumonia, pneumoconiosis, pulmonary tuberculosis.
- •Severe anemia.
- •Pregnant and lactating women.
- •Patients who had received corticosteroids, bronchodilators or CAM therapy within 2 weeks prior to enrollment.
结局指标
主要结局
Improvement in FEV1, FEV1/FVC ratio, PEF assessed by Spirometry
时间窗: 0th, 15th, and 30th day
次要结局
- Improvement in Asthma Control Test score(0th, 15th,and 30th day)
研究者
Dr Shabbir Hasan
National Institute of Unani Medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA