Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.
详细描述
In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.
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
- Triple (Participant, Care Provider, Investigator)
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
- •accord with the diagnosis of severe/critical novel coronavirus infection;
- •Age > 18 years old;
- •TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
- •Sign the informed consent form.
排除标准
- •Pregnant and lactating women;
- •Trauma, hematological malignancies, various solid tumors and obstetric complications;
- •Dementia, various mental patients and those who are unwilling to cooperate;
- •The patient is expected to die within the next 24 hours;
- •Combined with neuromuscular diseases affecting respiratory and motor functions;
- •people who have been bedridden for a long time for various reasons;
- •Clinical trial participants who are taking part in other intervention measures;
- •Those who are known to be allergic to the therapeutic drugs in this study.
研究组 & 干预措施
TCM plus conventional drug
The experimental group will receive three type of TCM inaddition conventional drug
干预措施: TCM plus conventional drug (Drug)
TCM placebo plus conventional drug
The control group will receive three type of placebo TCM inaddition conventional drug
干预措施: TCM placebo plus conventional drug (Drug)
结局指标
主要结局
28-day mortality
时间窗: Mortality on the 28th day of treatment
Proportion of patients who died of disease on day 28
次要结局
- Days without invasive mechanical ventilation(the 28 days of the treatment phase)
- invasive mechanical ventilation rate(28 days in the treatment phase)
- days of non-ICU(28 days in the treatment phase)
- time to clinical stability(every day in the treatment.)
- hospitalization time(the 28 days of the treatment phase)
- Clinical status of patients 15 days after randomization(The clinical status of patients was observed 15 days after randomization.)
- Quality of life(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.)
- TCM syndrome score(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.)
- SOFA score(The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted)