Moxibustion Plus Cupping in Convalescent Patients With COVID-19

Overview

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

Full Title of Study: “Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: December 2021

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.

Interventions

• 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.

Arms, Groups and Cohorts

• 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).
• No Intervention: Basic therapy
  • Basic therapy: rehabilitation direction and basic breathing exercise.

Clinical Trial Outcome Measures

Primary Measures

• The proportion of responder at week 4
  • Time Frame: 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.

Secondary Measures

• The proportion of responder at week 8
  • Time Frame: baseline, 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.
• The change in the average VAS score of main symptoms from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change in the severity VAS score of main symptoms from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change in the average VAS score of other symptoms from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change in mean frequency of diarrhea and spontaneous bowel movements from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The proportion of participants with ≥50%/75% improvement of VAS from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change of the walking distance of six-minute-walking test from baseline
  • Time Frame: baseline, week 4, week 8
  • At the end of week 4 and week 8, the walking distance of six-minute-walking test changed from baseline.
• The change of the lowest oxygen saturation of six-minute-walking test from baseline
  • Time Frame: baseline, week 4, week 8
  • At the end of week 4 and week 8, the lowest oxygen saturation of six-minute-walking test changed from baseline.
• The proportion of patients in recovery of pulmonary function at week 4
  • Time Frame: baseline, week 4
  • At the end of week 4, the proportion of patients in recovery of pulmonary function in all participants.
• The proportion of patients whose lung CT return to normal at week 4
  • Time Frame: baseline, week 4
  • Lung CT shows complete absorption of inflammation.
• The change of the WHO QOL-BREF score from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change of the SAS score from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change of the SDS score from baseline
  • Time Frame: baseline, week 4, week 8
  • 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.
• The change of the blood CRP/LYMPH#/NEUT% value from baseline
  • Time Frame: baseline, week 4
  • 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.
• subtype analysis
  • Time Frame: baseline, week 4
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Guang’anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborator
  • Hubei Hospital of Traditional Chinese Medicine
• Provider of Information About this Clinical Study
  • Principal Investigator: Xiaopin Wang, Secretary of Guang’anmen Hospital of China Academy of Chinese Medical Sciences – Guang’anmen Hospital of China Academy of Chinese Medical Sciences
• Overall Official(s)
  • Xiaopin Wang, Principal Investigator, Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Zhongyu Zhou, Principal Investigator, Hubei Hospital of Traditional Chinese Medicine
• Overall Contact(s)
  • Jiani Wu, +86 13426116653, handsom_mars@126.com