Moxibustion Plus Cupping in Convalescent Patients With COVID-19

NCT04374084 | Unknown

• 1 other identifier: 2020YFC0845000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Convalescence

Keywords

Moxibustion; COVID-19; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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 severity 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

Study Arms (2)

Moxibustion plus Cupping

EXPERIMENTAL

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

Basic therapy

NO INTERVENTION

Basic therapy: rehabilitation direction and basic breathing exercise.

Interventions

Moxibustion plus Cupping OTHER

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.

Moxibustion plus Cupping

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Hubei Provincial Hospital of Integrated Chinese & Western Medicine: collaborator
• Wuhan Hospital of Traditional Chinese Medicine: collaborator
• Wuhan Third Hospital: collaborator
• Huangshi Hospital of Traditional Chinese Medicine: collaborator
• Yichang Hospital of Traditional Chinese Medicine: collaborator
• Ezhou Hospital of Traditional Chinese Medicine: collaborator
• Hunan University of Traditional Chinese Medicine: collaborator
• The Hospital of Jiangxi University of Chinese Medicine: collaborator

Study Sites (1)

Hubei Province Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Convalescence

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Xiaopin Wang

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

• Zhongyu Zhou

  Hubei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiani Wu

CONTACT

+86 13426116653; handsom_mars@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 5, 2020
• Study Start: May 10, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: It depends.
• Access Criteria: It depends.

Locations

CN (1)