A Comparative study of Shwasahara Dashemani in the Management of Tamaka Shwasa(Bronchial Asthma)in Children-A randomized open label clinical Trail
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- relieve in the sign and symptom of shwasa roga or Bronchial asthma
研究概览
简要总结
Present clinical trial is randomised clinical trail on Tamaka Shwsa (Bronchial Asthma) in children of either sex between 2 to 12 years of age. Study will evaluate the role of Shwasahara Dashemani Avaleha from caraka samhita sutra sthan and Shwasahara Dashemani churna from caraka samhita sutra sthan. Intervational drug is Shwasahara Dashemani Avaleha while comparator agent is Shwasahara Dashemani churna.
Study is going to be conducted with primary aim to relieve the symptom of childhood asthma
Till date 50 patients are registered in clinical trial
As trial as in progress final conclusion or remarks can be drawn only after the completion of clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of 2 – 12 years of age of either sex.
- •Diagnosed cases of Tamaka Shwasa with at least 2 episodes of asthma symptoms during the previous year.
- •Mild persistent asthmatic patients.
- •Patients on other drug therapy will be included only after completion of wash out period of three weeks.
排除标准
- •Children of age below 2 years and above 12 years.
- •Patients with status asthmatics.
- •Evidence of active Concomitant Pulmonary Diseases other than asthma.
- •Evidence of requirement of intubations for asthma, or had been hospitalized for asthma within one month before, Unresolved Sinus Disease or an unresolved upper or lower respiratory tract infection within 2 weeks.
- •Concomitant severe systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurologicaletc.).
结局指标
主要结局
relieve in the sign and symptom of shwasa roga or Bronchial asthma
时间窗: Drug trail time 6 weeks | Follow up time 8 weeks
次要结局
- To prevent the recurrence of attack of breathlessness(To increase the immunity against allergens)