Clinical trial NCT04374084: Moxibustion Plus Cupping in Convalescent Patients With COVID-19
Official title: Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Convalescence
Keywords: Moxibustion
COVID-19
Randomized Clinical Trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: Hubei Provincial Hospital of Integrated Chinese & Western Medicine
name: Wuhan Hospital of Traditional Chinese Medicine
name: Wuhan Third Hospital
name: Huangshi Hospital of Traditional Chinese Medicine
name: Yichang Hospital of Traditional Chinese Medicine
name: Ezhou Hospital of Traditional Chinese Medicine
name: Hunan University of Traditional Chinese Medicine
name: The Hospital of Jiangxi University of Chinese Medicine
First posted: 2020-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
2. 18-70 years old;
3. 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;
4. Volunteers with informed consent;

Exclusion Criteria:

1. Surgery in the lung that affects lung function;
2. Rely on mechanical ventilation to maintain lung function;
3. Chronic lung diseases affecting lung function;
4. Diseases affecting heart function;
5. Severe basic diseases;
6. Resting heart rate \> 120/min, systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg;
7. Unstable angina or myocardial infarction in the past 1 month;
8. Severe obesity (BMI\>30kg/m2);
9. Allergic constitution;
10. Pregnant or lactating women;
11. Disabled patients;
12. Mentally ill Patients;
13. Participating in other clinical trials;
14. Poor compliance or other complicate conditions according to the researchers.

Primary outcomes:
measure: The proportion of responder at week 4
timeFrame: baseline, week 4
Secondary outcomes:
measure: The proportion of responder at week 8
timeFrame: baseline, week 8
measure: The change in the average VAS score of main symptoms from baseline
timeFrame: baseline, week 4, week 8
measure: The change in the severity VAS score of main symptoms from baseline
timeFrame: baseline, week 4, week 8
measure: The change in the average VAS score of other symptoms from baseline
timeFrame: baseline, week 4, week 8
measure: The change in mean frequency of diarrhea and spontaneous bowel movements from baseline
timeFrame: baseline, week 4, week 8
measure: The proportion of participants with ≥50%/75% improvement of VAS from baseline
timeFrame: baseline, week 4, week 8
measure: The change of the walking distance of six-minute-walking test from baseline
timeFrame: baseline, week 4, week 8
measure: The change of the lowest oxygen saturation of six-minute-walking test from baseline
timeFrame: baseline, week 4, week 8
measure: The proportion of patients in recovery of pulmonary function at week 4
timeFrame: baseline, week 4
measure: The proportion of patients whose lung CT return to normal at week 4
timeFrame: baseline, week 4
measure: The change of the WHO QOL-BREF score from baseline
timeFrame: baseline, week 4, week 8
measure: The change of the SAS score from baseline
timeFrame: baseline, week 4, week 8
measure: The change of the SDS score from baseline
timeFrame: baseline, week 4, week 8
measure: The change of the blood CRP/LYMPH#/NEUT% value from baseline
timeFrame: baseline, week 4
measure: subtype analysis
timeFrame: baseline, week 4
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Province Hospital
state: Hubei
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Xiaopin Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Zhongyu Zhou
role: PRINCIPAL_INVESTIGATOR
References: