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临床试验/CTRI/2021/03/032105
CTRI/2021/03/032105尚未招募不适用

Evaluation of role of add on probiotics on impact of lung function and bronchial asthma control - A randomized control trial

Boopathi S1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To evaluate the role of add on probiotics on impact of lung function by spirometry and bronchial asthma control

研究概览

简要总结

This study is a randomized parallel group trial to evaluate the role of add on probiotics (lactobacillus fermentum 4 billion cells once daily for 2 months) on impact of lung function and bronchial asthma control that will be conducted in Chettinad Hospital and Research Institute, Kelambakkam,Tamil Nadu, India.The primary outcome is to evaluate the role of add on probiotics on impact of lung function by spirometry and bronchial asthma control.The secondary outcome is to study the impact of probiotics supplementation in risk of asthma exacerbation,allergic rhinitis and its impact on asthma scoring for a period of 2 months.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •All adult stable asthma with or without atopy and allergic rhinitis Both genders.

排除标准

  • •Acute Respiratory infection including Tuberculosis Exacerbation Subjects contraindicated and unable to perform spirometry Underlying respiratory disorders.

结局指标

主要结局

To evaluate the role of add on probiotics on impact of lung function by spirometry and bronchial asthma control

时间窗: Baseline,4 weeks,8 weeks and 12 weeks

次要结局

  • To study the impact of probiotics supplementation in risk of asthma exacerbation allergic rhinitis and its impact on asthma scoring(3 months)

研究者

发起方
Boopathi S
申办方类型
Private medical college

研究点 (1)

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