An pilot study to assess the effectiveness of Bringaraja thailam for the management of childhood bronchial asthma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline
研究概览
简要总结
INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of siddha herbal formulation Bringaraja thailam. Sooli Kanam has been described in the siddha literatures as the diseases frequently occuring in children . According to siddha texts, It is characterized by prolonged expiration and expiratory wheeze, prolonged cough, abdominal bloating and discomfort due to mouth breathing. It can be closely compared withchildhood Asthma. Asthma is a chronic inflammatory disease characterized by airway obstruction, airway hyper responsiveness manifest as wheeze, cough, shortness of breath and chest tightness. .Asthma tends to affect about 10% children globally. Recent data have shown that asthma continues to affect 6 million school aged children with approximately half of these children experiencing asthma attack each year. MATERIALS AND METHODS: A total of 10 patients within age limit of 6 to 12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSIONS: Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline and also assess the improvement in the symptoms by GINA Global Initiative for Asthma Guidelines 2022 and St. Georges respiratory questionnaire.
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
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Children of both sex in the age group of 6 to 12 years 2 Is diagnosed with asthma by following the Global Initiative for Asthma (GINA) guidelines and St Georges respiratory questionnaire 3 Children having FEV1 greater than 60 percentage TO less than 80 percentage 4 Patient willing to co-operate for spirometry test 5 Parent willing to sign the informed consent form.
排除标准
- •1 H/O Pulmonary tuberculosis 2 H/O Bronchiectasis 3 Subject unable to do Spirometry 4 Any other serious illness.
结局指标
主要结局
Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline
时间窗: Effectiveness of the trial drug will be assessed by spirometry before and after treatment
次要结局
- Improvement in the symptoms assessed by GINA Global Initiative for Asthma Guidelines 2022 and St Georges Respiratory questionnaire
研究者
Dr Karthika Prakasan
Research and hospital, National institute of siddha
