Back to resultsMoxibustion Plus Cupping in Convalescent Patients With COVID-19
Primary Purpose
COVID-19, Convalescence
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Moxibustion plus Cupping
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Moxibustion, COVID-19, Randomized Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
- 18-70 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;
Exclusion Criteria:
- 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.
Sites / Locations
- Hubei Province HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Moxibustion plus Cupping
Basic therapy
Arm Description
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).
Basic therapy: rehabilitation direction and basic breathing exercise.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
The proportion of patients whose lung CT return to normal at week 4
Lung CT shows complete absorption of inflammation.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04374084
First Posted
April 20, 2020
Last Updated
November 16, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Hubei Hospital of Traditional Chinese Medicine, Hubei Provincial Hospital of Integrated Chinese & Western Medicine, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Third Hospital, Huangshi 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
1. Study Identification
Unique Protocol Identification Number
NCT04374084
Brief Title
Moxibustion Plus Cupping in Convalescent Patients With COVID-19
Official Title
Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Hubei Hospital of Traditional Chinese Medicine, Hubei Provincial Hospital of Integrated Chinese & Western Medicine, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Third Hospital, Huangshi 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Convalescence
Keywords
Moxibustion, COVID-19, Randomized Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moxibustion plus Cupping
Arm Type
Experimental
Arm Description
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).
Arm Title
Basic therapy
Arm Type
No Intervention
Arm Description
Basic therapy: rehabilitation direction and basic breathing exercise.
Intervention Type
Other
Intervention Name(s)
Moxibustion plus Cupping
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of responder at week 4
Description
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.
Time Frame
baseline, week 4
Secondary Outcome Measure Information:
Title
The proportion of responder at week 8
Description
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.
Time Frame
baseline, week 8
Title
The change in the average VAS score of main symptoms from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change in the severity VAS score of main symptoms from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change in the average VAS score of other symptoms from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change in mean frequency of diarrhea and spontaneous bowel movements from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The proportion of participants with ≥50%/75% improvement of VAS from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change of the walking distance of six-minute-walking test from baseline
Description
At the end of week 4 and week 8, the walking distance of six-minute-walking test changed from baseline.
Time Frame
baseline, week 4, week 8
Title
The change of the lowest oxygen saturation of six-minute-walking test from baseline
Description
At the end of week 4 and week 8, the lowest oxygen saturation of six-minute-walking test changed from baseline.
Time Frame
baseline, week 4, week 8
Title
The proportion of patients in recovery of pulmonary function at week 4
Description
At the end of week 4, the proportion of patients in recovery of pulmonary function in all participants.
Time Frame
baseline, week 4
Title
The proportion of patients whose lung CT return to normal at week 4
Description
Lung CT shows complete absorption of inflammation.
Time Frame
baseline, week 4
Title
The change of the WHO QOL-BREF score from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change of the SAS score from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change of the SDS score from baseline
Description
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.
Time Frame
baseline, week 4, week 8
Title
The change of the blood CRP/LYMPH#/NEUT% value from baseline
Description
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.
Time Frame
baseline, week 4
Title
subtype analysis
Description
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.
Time Frame
baseline, week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
18-70 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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiani Wu
Phone
+86 13426116653
Email
handsom_mars@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaopin Wang
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhongyu Zhou
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Province Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongyu Zhou
Phone
+86 18672308659
Email
2209447940@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Moxibustion Plus Cupping in Convalescent Patients With COVID-19
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