Moxibustion Plus Cupping in Convalescent Patients With COVID-19

Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Convalescence
• Intervention / Treatment: Other: Moxibustion plus Cupping

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiani Wu; Phone Number: +86 13426116653; Email: handsom_mars@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Province Hospital
      • Contact: Zhongyu Zhou; Phone Number: +86 18672308659; Email: 2209447940@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxibustion plus Cupping; Moxibustion plus cupping and basic therapy (rehabilitation direction and basic breathing exercise) once a day for 4 weeks (28 sessions).The moxibustion plus cupping treatments were divided into 2 alternating formulas: A: Monday, Wednesday, Friday and Sunday: moxibustion on bilateral Fengmen (BL12), Feishu (BL13) and Pishu(BL20) B: Tuesday, Thursday and Saturday: moxibustion on Zhongwan (RN12), Qihai (RN6), bilateral Tianshu(ST25) and Zusanli(ST36) + cupping on bilateral Feishu(BL13) Geshu(BL17) Pishu(BL20) The 2 formulas were used alternatively every other day, 7 times per week, for 4 weeks. Moxibustion acupoint addition: profuse sweating added Fuliu (KI7), insomnia added Shenmen(HT7) anxiety or depression added Neiguan (PC6).	Other: Moxibustion plus Cupping; 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.
No Intervention: Basic therapy; Basic therapy: rehabilitation direction and basic breathing exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 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.	baseline, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline, week 4
The proportion of patients whose lung CT return to normal at week 4	Lung CT shows complete absorption of inflammation.	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.	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.	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.	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.	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.	baseline, week 4

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Hubei Hospital of Traditional Chinese Medicine; Wuhan Third Hospital; Huangshi Hospital of Traditional Chinese Medicine; Hubei Provincial Hospital of Integrated Chinese & Western Medicine; Wuhan Hospital of Traditional Chinese Medicine; Yichang Hospital of Traditional Chinese Medicine; Ezhou Hospital of Traditional Chinese Medicine; The First Hospital of Hunan University of Chinese Medicine; The Hospital of Jiangxi University of Chinese Medicine
• Investigators: Principal Investigator: Xiaopin Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Principal Investigator: Zhongyu Zhou, Hubei Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Randomized Clinical Trial; Moxibustion
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Convalescence
• Other Study ID Numbers: 2020YFC0845000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question.
• IPD Sharing Time Frame: It depends.
• IPD Sharing Access Criteria: It depends.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No