Moxibustion Plus Cupping in Convalescent Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374084
• Other study ID #: 2020YFC0845000
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiani Wu
• Phone: +86 13426116653
• Email: handsom_mars[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Convalescence
• COVID-19

Intervention

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.

Locations

Country	Name	City	State
China	Hubei Province Hospital	Wuhan	Hubei

Sponsors (10)

Lead Sponsor

Collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Ezhou Hospital of Traditional Chinese Medicine, Huangshi Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Hubei Provincial Hospital of Integrated Chinese & Western Medicine, The First Hospital of Hunan University of Chinese Medicine, The Hospital of Jiangxi University of Chinese Medicine, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Third Hospital, Yichang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The proportion of patients whose lung CT return to normal at week 4	Lung CT shows complete absorption of inflammation.	baseline, week 4
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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