The outcomes of using L-glutathione and N-acetylcysteine as inhalation agents in copd patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.improvement in pulmnory function tests
研究概览
简要总结
This study is a randomized, double-blind, parallel-group, single-center trial comparing the efficacy of adjunctive therapy in COPD patients. The trial involves a combination therapy of glutathione (50 mg) and N-acetylcysteine (100 mg), administered twice daily via inhalation route along with standard therapy for three months, versus a placebo-controlled standardized therapy for three months. A total of 60 patients are included in the trial. The primary outcome is the improvement in pulmonary function tests before and after the trial. The secondary outcome is the assessment of adverse drug events every month for three months.
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
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with obstructive lung disease.
排除标准
- •acute severe bronchial asthma
- •allergic rhinitis
- •bronchiectasis
- •Active pneumonia
- •Chronic kidney disease more than stage 3b
- •heart failure with reduced ejection fraction lesser than 40.
结局指标
主要结局
1.improvement in pulmnory function tests
时间窗: 3 months
2.decrease in copd assessment score
时间窗: 3 months
次要结局
- assessment of adverse events(3 months)
研究者
Dr Prem balaji reddy
Saveetha Medical College