NCT04374084Unknown不适用
Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of responder at week 4
研究概览
简要总结
This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.
详细描述
Moxibustion plus cupping may be effective and safe for convalescent patients with COVID-19, but evidence is limited. The randomized clinical trial may help to provide evidence-based factors for improving the patients' symptoms in the convalescence of COVID-19.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
- •18-70 years old;
- •chest tightness/fatigue/shortness of breath/cough, with at least 2 of the above symptoms and the average VAS score (last 48 hours) ≥ 40 points;
- •Volunteers with informed consent;
排除标准
- •Surgery in the lung that affects lung function;
- •Rely on mechanical ventilation to maintain lung function;
- •Chronic lung diseases affecting lung function;
- •Diseases affecting heart function;
- •Severe basic diseases;
- •Resting heart rate > 120/min, systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg;
- •Unstable angina or myocardial infarction in the past 1 month;
- •Severe obesity (BMI>30kg/m2);
- •Allergic constitution;
- •Pregnant or lactating women;
- •Disabled patients;
- •Mentally ill Patients;
- •Participating in other clinical trials;
- •Poor compliance or other complicate conditions according to the researchers.
结局指标
主要结局
The proportion of responder at week 4
时间窗: baseline, week 4
The responder is defined as the participants with ≥ 50% average VAS decrease of chest tightness and fatigue compared with baseline. The VAS ranges from 0 to 100.
次要结局
- The change of the walking distance of six-minute-walking test from baseline(baseline, week 4, week 8)
- The change of the lowest oxygen saturation of six-minute-walking test from baseline(baseline, week 4, week 8)
- The proportion of patients in recovery of pulmonary function at week 4(baseline, week 4)
- The proportion of responder at week 8(baseline, week 8)
- The change in the average VAS score of main symptoms from baseline(baseline, week 4, week 8)
- The change in the average VAS score of other symptoms from baseline(baseline, week 4, week 8)
- The change in mean frequency of diarrhea and spontaneous bowel movements from baseline(baseline, week 4, week 8)
- The proportion of participants with ≥50%/75% improvement of VAS from baseline(baseline, week 4, week 8)
- The change of the SDS score from baseline(baseline, week 4, week 8)
- The change in the severity VAS score of main symptoms from baseline(baseline, week 4, week 8)
- The proportion of patients whose lung CT return to normal at week 4(baseline, week 4)
- The change of the SAS score from baseline(baseline, week 4, week 8)
- The change of the WHO QOL-BREF score from baseline(baseline, week 4, week 8)
- The change of the blood CRP/LYMPH#/NEUT% value from baseline(baseline, week 4)
- subtype analysis(baseline, week 4)
研究者
Xiaopin Wang
Secretary of Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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