Moxibustion Plus Cupping in Convalescent Patients With COVID-19

NCT ID: NCT04374084

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-10

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Convalescence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Moxibustion COVID-19 Randomized Clinical Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Moxibustion plus Cupping

Intervention Type 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.

Basic therapy

Basic therapy: rehabilitation direction and basic breathing exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Hubei Provincial Hospital of Integrated Chinese & Western Medicine

UNKNOWN

Sponsor Role collaborator

Wuhan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan Third Hospital

OTHER

Sponsor Role collaborator

Huangshi Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Yichang Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Ezhou Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The Hospital of Jiangxi University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaopin Wang

Secretary of Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaopin Wang

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Zhongyu Zhou

Role: PRINCIPAL_INVESTIGATOR

Hubei Hospital of Traditional Chinese Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hubei Province Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jiani Wu

Role: CONTACT

Phone: +86 13426116653

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhongyu Zhou

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020YFC0845000

Identifier Type: -

Identifier Source: org_study_id