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COVID-19NCT04374084

Moxibustion Plus Cupping in Convalescent Patients With COVID-19

A study testing Moxibustion plus Cupping in people with COVID-19 and Convalescence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID-19, Convalescence
What is being tested?
Moxibustion plus Cupping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
10 May 2020to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Jiani Wu contact

+86 13426116653

handsom_mars@126.com

China1 site, 1 recruiting

  • Hubei Province Hospital

    Wuhan, Hubei

    Zhongyu Zhou, +86 18672308659, 2209447940@qq.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Moxibustion plus Cupping
Keywords
Moxibustion, COVID-19, Randomized Clinical Trial
Medical subject headings
COVID-19, Convalescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moxibustion plus CuppingOther

    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.

Study groups in NCT04374084
Study groupRoleWhat they receive
Moxibustion plus CuppingExperimentalMoxibustion 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).
Receives: Other: Moxibustion plus Cupping
Basic therapyNo interventionBasic therapy: rehabilitation direction and basic breathing exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, week 4

Secondary outcomes (15)

  1. 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.

    Measured: baseline, week 8

  2. 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.

    Measured: baseline, week 4, week 8

  3. 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.

    Measured: baseline, week 4, week 8

  4. 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.

    Measured: baseline, week 4, week 8

  5. 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.

    Measured: baseline, week 4, week 8

  6. 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.

    Measured: baseline, week 4, week 8

  7. 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.

    Measured: baseline, week 4, week 8

  8. 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.

    Measured: baseline, week 4, week 8

  9. 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.

    Measured: baseline, week 4

  10. The proportion of patients whose lung CT return to normal at week 4

    Lung CT shows complete absorption of inflammation.

    Measured: baseline, week 4

  11. 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.

    Measured: baseline, week 4, week 8

  12. 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.

    Measured: baseline, week 4, week 8

  13. 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.

    Measured: baseline, week 4, week 8

  14. 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.

    Measured: baseline, week 4

  15. 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.

    Measured: baseline, week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start10 May 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04374084
Sponsor's protocol ID
2020YFC0845000
Status last verified
Aug 2021
First submitted
20 Apr 2020
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question.

Questions about this trial

What is this clinical trial studying?

A study testing Moxibustion plus Cupping in people with COVID-19 and Convalescence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiani Wu (+86 13426116653, handsom_mars@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of responder at week 4 (time frame: baseline, week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04374084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.

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