A randomized comparative clinical study to evaluate the combined effect of siravyadha followed by bharangi arka nebulization with the standard group bharangi arka nebulization in tamaka shwasa (bronchial asthma)
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Samyak siravyadha lakshanas will be observed:
研究概览
简要总结
This study is an open label, double arm randomized prospective clinical trial to evaluate the combined effect of siravyadha followed by bharangi arka nebulization with the standard group bharangi arka nebulization in Tamaka Shwasa( Bronchial Asthma) that will be conducted in India.
Primary outcome measures will be laghava, vedana shanti, vyadhirvega kshaya, mana prasada and secondary outcome measures will be assessed on the basis of relief in the signs and symptoms of Tamaka Shwasa, which will be assigned suitable scores(GINA) Time points will be before treatment, immediately after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in the subjects of group A.
While in group B, primary and secondary measure will be assessed before treatment, 15 minutes after nebulization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild and moderate grade of Bronchial Asthma as per GINA
- •Subjects with Hb more than 10 gm percent
- •Subjects with normal clotting and bleeding time.
排除标准
- •Subjects who are known case of Tuberculosis Emphysema COPD
- •Subjects who are known case of Cardiac Diseases
- •Subjects who are known case of HIV and HBsAg
- •Subjects with uncontrolled Diabetes Mellitus and Hypertension.
- •Subjects with Bleeding Disorders.
结局指标
主要结局
Samyak siravyadha lakshanas will be observed:
时间窗: Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A | In Group B, measures will be assessed before treatment and 15 minutes after nebulization
1. Laghava
时间窗: Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A | In Group B, measures will be assessed before treatment and 15 minutes after nebulization
2. Vedana shanti
时间窗: Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A | In Group B, measures will be assessed before treatment and 15 minutes after nebulization
3. Vyadhirvega kshaya
时间窗: Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A | In Group B, measures will be assessed before treatment and 15 minutes after nebulization
4. Mana prasada
时间窗: Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A | In Group B, measures will be assessed before treatment and 15 minutes after nebulization
次要结局
- The effect of the therapy will be assessed on the basis of relief of following signs and symptoms of Tamaka Shwasa which will be assigned suitable scores(GINA scale):(1. Gurukuraka)