Clinical study to evaluate the Efficacy and safety of ROSELLE in patients with Bronchial asthma and Malnutrition.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of symptom scores & use of β-agonist, Pulmonary function tests and Absolute Eosinophil counts.
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.
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The selected subjects will receive roselle liquid formulation 30 ml (mixed in 60ml warm water) orally once daily after food for 3 months.
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The patients will be on standard treatment as well for bronchial asthma as per standard guidelines.
The Primary end points of this study will be:
Evaluation of symptom scores & use of β -agonist, Pulmonary function tests and Absolute Eosinophil counts.
The effect of treatment on symptom scores will be evaluated by analyzing average daily symptom scores at weeks 4, 8, and 12 of treatment on the basis of 3 categories: daytime
symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9.
The Secondary end points of this study will be:
Evaluation of nutritional status using DETERMINE Your nutritional health checklist questionnaire and BMI and mid arm circumference will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-59 years(both sex) suffering from mild and moderate-persistent bronchial asthma characterized by -Daily symptoms of asthma -Nocturnal awakenings more than once per week -Daily need for SABAs for symptom relief -More than just minor limitation in normal activity -FEV1 between 60 and 80 percent of predicted and an FEV/FVC ratio less than the lower confidence interval for normal.
排除标准
- •Patients with fever, drug-induced asthma, aspirin intolerance triad, asthma with fixed airflow limitation, asthma with obesity, late-onset asthma will be excluded.
- •History of heart, liver, kidney, or other organ diseases; -Allergy or intolerance to the individual constituents in NONIZHI -Subjects who are pregnant and lactating mothers, or with any serious or invalidating other disease limiting full adhesion to the protocol.
- •Participation in an investigational drug trial in the 30 days prior to the screening visit.
结局指标
主要结局
Evaluation of symptom scores & use of β-agonist, Pulmonary function tests and Absolute Eosinophil counts.
时间窗: week 4, 8 and 12
The effect of treatment on symptom scores will be evaluated by analysing average daily symptom scores of treatment on the basis of
时间窗: week 4, 8 and 12
3 categories: daytime symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9.
时间窗: week 4, 8 and 12
次要结局
- Evaluation of nutritional status using DETERMINE Your nutritional health(checklist questionnaire and BMI and mid arm circumference)