Efficacy of Fuzheng Huayu Tablets for Treating Pulmonary Inflammation in Patients With COVID-19: A Case-Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- the percentage of patients showing improvement in chest CT
研究概览
简要总结
The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory illness similar to SARS and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected 2019-nCoV, most of them should receive supportive care to help relieve symptoms. This clinical trial is to evaluate the effect of Fuzheng Huayu tablet on lung inflammation in intensive patients with novel coronavirus pneumonia and reduce the progressive rate to critical type.
详细描述
In December 2019, new coronavirus pneumonia (NCP) occurred in Wuhan, Hubei Province, which spread rapidly. Some of the patients developed into severe or critical illness. It became an international concerned public health emergencies and one of the major epidemics seriously endangering people's health and public safety after severe acute respiratory syndrome (SARS) in 2003.
At present, we lack the specific treatment for NCP. The anti- novel coronavirus drugs are been conducting in clinical trials, and the other options includes the symptomatic treatment. The pathological mechanism of the disease is not clear, but due to the continuous development of inflammation, some cases can become severe or critical, which threatening the life and health of patients. Intensive cases with obvious inflammation, after the control of acute symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery of lung function. Therefore, actively reducing lung inflammation, controlling and reversing pulmonary fibrosis is of great significance for the life and health of patients Infected novel coronavirus.
Our previous study found that Fuzheng Huayu prescription can reduce the inflammation and fibrosis of the lung in the model rats, and improve the lung function of the patients with COPD. Therefore, we hope to take Fuzheng Huayu tablet to NCP patients, and observe whether it can reduce the lung inflammation of patients, so as to reduce the rate of progression of critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were included if they (1) had COVID-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form.
排除标准
- •Patients were excluded if they (1) had critical COVID-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade IV), severe liver or kidney disease, bronchial asthma, COPD, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.
研究组 & 干预措施
FZHY Group
conventional therapy plus Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time.)
干预措施: Fuzheng Huayu tablet (Drug)
结局指标
主要结局
the percentage of patients showing improvement in chest CT
时间窗: Week 2
Evaluation of the therapeutic effect of Fuzheng huayu tablet
次要结局
- routine blood examination(Week 2)
- procalcitonin level(Week 2)
- clinical remission rate of respiratory symptoms(week 2)
- C-reactive protein level(Week 2)
- remission rate or progression rate of critical illness(Week 2)
- oxygen saturation(Week 2)
研究者
Liu Chenghai
Institute Director;PhD
ShuGuang Hospital