A clinical study on the management of Tamaka Shwasa with special reference to Bronchial Asthma in children with Shwasahara Dashemani
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 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 trail is randomized double blind study on Tamaka Shwasa wsr to bronchial asthma in children of either sex between 2 to 12 years of age. Study will evaluate the role of Shwasahara Dashemani a combination of ten herbs from Charaka Samhita. Intervention drug is Shwasaha Dashemani churna prepared with seven bhavana of Kashaya of the same drug of Shwasahara Dashemani while comparator agent is Shwasahara Dashemani churna prepared with single bhavana with the kashaya of drugs of Shwasahara Dashemani
Study is going to be conducted with primary aim to relieve the symptoms of childhood asthma
Till date 30 patients are registered in clinical trail
As trail is in progress final conclusion or remarks can be drawn only after the completion of clinical trail
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 to 12 years of age of either sex Diagnosed cases of Tamaka Shwasa Bronchial Asthma with at least 2 episodes of asthma symptoms during the previous year Patients on other drug therapy will be included only after completion of wash out period of 3 weeks Patients or Parents or legal guardians willing to give written informed consent or assent.
排除标准
- •Children of age below 2 years and above the 12 years Evidence of active concomitants pulmonary disease other than asthma Evidence of requirement of intubations for asthma or had been hospitalized for asthma within one month before.
- •Had unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 2 weeks Patients on active corticosteroid therapy or more than 4 short courses of oral corticosteroids within the year preceding the screening visit or any oral corticosteroids in the preceding 4 weeks Use of Astemizole Nedocromil Cromolyn long acting beta agonists Ketotifen or Theophylline within 2 weeks before Concomitant severe decompensated systemic disease cardiovascular renal hepatic endocrine hematological neurological immunological.
结局指标
主要结局
Relieve in the sign and symptom of Shwasa Roga or Bronchial asthma
时间窗: 8 weeks
次要结局
- To prevent the recurrence of attacks of breathlessness(To increase the immunity against allergens)