This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Moxibustion: The burning of a small, thimble sized, smoldering plug of dried leaves on the skin at an acupuncture point. Usually the plugs contain leaves of mugwort or moxa. Cupping takes the pot as a tool, uses the combustion to remove the air in the pot, causes a negative pressure, and makes it adsorb on the skin of the acupoints. Use"Baixiaojiu"moxibustion on each acupoint for 10-15 minutes, the temperature of moxibustion should be adjusted within patient's tolerance level. Use diameter of 5-6 cm acuum cupper to cupping on each acupoint for 5-8 minutes.
Hubei Province Hospital
Wuhan, Hubei, China
RECRUITINGThe proportion of responder at 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.
Time frame: baseline, week 4
The proportion of responder at week 8
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.
Time frame: baseline, week 8
The change in the average VAS score of main symptoms from baseline
At the end of week 4 and week 8, the change in the average VAS score of main clinical symptoms (chest tightness, fatigue, short of breath and cough) will be assessed from baseline. VAS ranges from 0-100.
Time frame: baseline, week 4, week 8
The change in the severity VAS score of main symptoms from baseline
At the end of week 4 and week 8, the change in the severity VAS score of main clinical symptoms (chest tightness, fatigue, short of breath and cough) will be assessed from baseline. VAS score ranges from 0-100.
Time frame: baseline, week 4, week 8
The change in the average VAS score of other symptoms from baseline
At the end of week 4 and week 8, the change in the average VAS score of other symptoms (insomnia, sweating, mental fatigue, inappetence, mental stress) will be assessed from baseline. VAS score ranges from 0-100.
Time frame: baseline, week 4, week 8
The change in mean frequency of diarrhea and spontaneous bowel movements from baseline
At the end of week 4 and week 8, the change in mean frequency of diarrhea and spontaneous bowel movements in the past 1 week will be assessed from baseline.
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Time frame: baseline, week 4, week 8
The proportion of participants with ≥50%/75% improvement of VAS from baseline
At the end of week 4 and week 8, the proportion of participants with ≥50%/75% VAS change of clinical symptoms (chest tightness, fatigue, short of breath, cough, insomnia, sweating, mental fatigue, inappetence, mental stress) will be assessed. VAS score ranges from 0-100.
Time frame: baseline, week 4, week 8
The change of the walking distance of six-minute-walking test from baseline
At the end of week 4 and week 8, the walking distance of six-minute-walking test changed from baseline.
Time frame: baseline, week 4, week 8
The change of the lowest oxygen saturation of six-minute-walking test from baseline
At the end of week 4 and week 8, the lowest oxygen saturation of six-minute-walking test changed from baseline.
Time frame: baseline, week 4, week 8
The proportion of patients in recovery of pulmonary function at week 4
At the end of week 4, the proportion of patients in recovery of pulmonary function in all participants.
Time frame: baseline, week 4
The proportion of patients whose lung CT return to normal at week 4
Lung CT shows complete absorption of inflammation.
Time frame: baseline, week 4
The change of the WHO QOL-BREF score from baseline
At the end of week 4 and week 8, the WHO Quality of Life-BREF (WHO QOL-BREF) score changed from baseline. WHO QOL-BREF ranged from 4 to 20 with higher scores as the better quality of life.
Time frame: baseline, week 4, week 8
The change of the SAS score from baseline
At the end of week 4 and week 8, the Self-Rating Anxiety Scale (SAS) score changed from baseline. The standard SAS ranged from 25 to 100 with higher score as the worse anxiety.
Time frame: baseline, week 4, week 8
The change of the SDS score from baseline
At the end of week 4 and week 8, the Self-Rating Depression Scale (SDS) score changed from baseline.The standard SAS ranged from 25 to 100 with higher score as the worse depression.
Time frame: baseline, week 4, week 8
The change of the blood CRP/LYMPH#/NEUT% value from baseline
At the end of week 4, the blood C-reactive protein (CRP) value, blood lymphocyte count (LYMPH#) and the percentage of blood neutrophils (NEUT%) value will be assessed compared with baseline.
Time frame: baseline, week 4
subtype analysis
Subtype analysis of age (≤40 years old, \>40 years old), gender (male, female), and severity of the disease (mild, moderate, heavy, critical) will be performed in the primary outcome.
Time frame: baseline, week 4