Evaluation of comparative efficacy of Herbal Nebulization versus Asthalin / Budecort Nebulization in the prevention and management of Jeerna Tamaka shwasa (Chronic Bronchial asthma) In Children: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief from sign and symptoms of Breathlessness, Relief from cough, Relief from dyspneic attacks, Relief in night waking due to asthma
研究概览
简要总结
The volunteers will be informed about the study protocol.
Willing participants will be randomly selected as per a computer-generated table. The clinical research format will be prepared and validated.
Before the study approval is taken from the IEC, MGACHRC, Salod Wardha, and CTRI registration will be done.
After selection, each participant will be tested individually and selected according to the selection criteria.
They are divided into two groups.
The trial is a randomized controlled clinical trial. It will include 28 days of treatment with weekly assessment on the 7th,14th, and 28th day, and follow-up on the 30th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with mild to moderate asthma Informed consent from parents or guardians Children in Aavegavastha of Tamakswasa.
排除标准
- •Acute exacerbation of asthma requiring hospitalization Known hypersensitivity to herbal preparation Other chronic respiratory or systemic illness Vegavastha of Tamakswasa.
结局指标
主要结局
Relief from sign and symptoms of Breathlessness, Relief from cough, Relief from dyspneic attacks, Relief in night waking due to asthma
时间窗: weekly assessment on 7th, 14th and 28th day in the 4 week 28 day study duration
次要结局
- Relief from activity limitations due to asthma(28 days)
研究者
Dr Angad Marotrao Gaikwad
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha