To study the efficacy of Bharangyadi Kashaya in comparison with Nidhigdikadi Kashaya in Tamaka Swasa, Bronchial Asthma: A controlled randomized clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in peak Expiratory Flow Rate and Absolute Eosinophil count in patients diagnosed with Tamaka Swasa.
研究概览
简要总结
A controlled clinical study on the efficacy of Bharangyadi Kashaya in the management of Tamaka Swasa (Bronchial Asthma) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Tamaka Swasa (Bronchial Asthma) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group)15 subjects in each group respectively. Group A (Trial drug/Intervention group) includes 15 subjects qualifying inclusion criteria of the current study who will be administered Bharangyadi Kashaya internally in the dose of 50ml in the morning after food for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial follow up on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Nidhigdikadi Kashaya internally in the dose of 50ml in the morning after food for 30days starting from day-01 of trial,assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial follow up on 45th day. Primary outcome will be the Improvement in Peak Expiratory Flow Rate and Absolute Eosinophil count after 30 days in patients with Tamaka Swasa. The secondary outcome measure will be improvement noticed in the reduction of signs and symptoms based on Asthma Control Questionnaire after 30 days in patients with Tamaka Swasa.Statistical analysis will be done through data obtained based on, before and after treatment assessment.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects fulfilling the diagnostic criteria of Tamaka Swasa.
- •2.Subjects having peak expiratory flow rate greater than 50 percentage of predicted value of Peak Expiratory Flow Rate chart.
- •3.Subjects within the age group of 18 to 60 years.
- •4.Chronicity less than or equal to 10 years.
排除标准
- •1.Acute condition of Bronchial Asthma, Status asthmaticus.
- •2.Subjects suffering from associated diseases like Tuberculosis, pneumonia, Cardiac diseases, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension.
- •3.Subjects having peak expiratory flow rate less than 50 percentage of predicted value of Peak Expiratory Flow Rate chart.
- •4.Subjects who are on corticosteroids.
- •5.Chronicity of more than 10 years.
- •6.Pregnant and lactating women.
结局指标
主要结局
Improvement in peak Expiratory Flow Rate and Absolute Eosinophil count in patients diagnosed with Tamaka Swasa.
时间窗: 0th day (Baseline), 15th day, 30th day and 45th day
次要结局
- Improvements in reduction of signs and symptoms in patients diagnosed with Tamaka Swasa based on Asthma Control Questionnaire(0th day (Baseline), 15th day, 30th day and 45th day)
研究者
Dr B Sanjuktha Shree
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore