Traditional Chinese Medicine or Low-dose Dexamethasone in Symptomatic Patients With Post-COVID-19 Parenchymal Lung Abnormalities: a Randomized Controlled Trial Three Arm, Parallel Group, Single Blind, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Lung CT scan
研究概览
简要总结
The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.
Participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COVID-19 pneumonia；
- •3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;
- •Modified Medical Research Council (mMRC) score ⩾2 or hypoxemia;
- •Imaging severity assessment of pneumonia: CT severity scores (CTSS):≥5；
- •Signed the informed consent.
排除标准
- •Participants still admitted to intensive care unit at the time of enrollment;
- •Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;
- •Taking glucocorticoids or immunosuppressants because of other chronic diseases;
- •Contraindications of glucocorticoid;
- •Heart failure(NYHA III or IV);
- •Participants with renal replacement therapy;
- •Psychiatric disorders or cognitive impairments;
- •The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.
研究组 & 干预措施
controlled group
conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.
干预措施: conventional western medicine treatment (Other)
dexamethasone group
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
干预措施: conventional western medicine treatment (Other)
dexamethasone group
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
干预措施: Dexamethasone oral tablet (Drug)
Chinese medicine group
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
干预措施: conventional western medicine treatment (Other)
Chinese medicine group
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
干预措施: Traditional Chinese medicine decoction (Other)
结局指标
主要结局
Lung CT scan
时间窗: 1 month
compared with base,≥90% pneumonia obsorbed
次要结局
- Lung CT scan(3 months)
研究者
Zhenguo Zhai,MD,PhD
Chief physician of PCCM
China-Japan Friendship Hospital