Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

NCT ID: NCT06777472

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-08-31

Brief Summary

For patients with poor asthma control, on the basis of treatment guided by GINA guidelines, lung-benefiting moxibustion treatment will be given, and it will be applied 10 days before "early onset", once every 10 days, and the follow-up was 45 weeks, 1 cycle per year, for 2 consecutive cycles (2 years). The annual number of flare-up of asthma patients will be used as the main outcome index to evaluate the clinical effect of lung-benefiting moxibustion on reducing exacerbations of asthma. By observing immunoglobulin, T cell subsets and other indicators, the advantage population and mechanism of moxibustion in treating patients with poor asthma control will be clarified.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

test group

On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows：

1. The procedure of moxibustion includes 13 steps: selecting the body position, choosing the point, disinfecting, applying ginger juice, sprinkling moxibustion powder, covering mulberry paper, laying ginger mud, placing moxa cone, lighting moxa cone, changing moxa cone, removing ginger mud, gently rubbing moxibustion spot and placing blisters; The time of each application of moxibustion is 90 minutes.

2. Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles.

Group Type: EXPERIMENTAL

lung-benefiting moxibustion

Intervention Type: OTHER

A kind of external treatment，the treatment theory is to treat winter diseases in summer.

The specific drug comes from "GINA (2024)"

Intervention Type: DRUG

Refer to "GINA (2024)".

control group

Refer to "GINA (2024)". Regulations on combined medication: When complications occur during treatment, symptomatic treatment can be given according to the clinical situation. At the same time, the name, manufacturer, batch number, usage, dosage, course of treatment, etc. of the drug should be recorded in detail.

Group Type: ACTIVE_COMPARATOR

The specific drug comes from "GINA (2024)"

Intervention Type: DRUG

Refer to "GINA (2024)".

Interventions

lung-benefiting moxibustion

A kind of external treatment，the treatment theory is to treat winter diseases in summer.

Intervention Type: OTHER

The specific drug comes from "GINA (2024)"

Refer to "GINA (2024)".

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who meet the diagnosis of asthma (remission);
• Patients with poor clinical control;
• Age 18-80 years old;
• Voluntarily undergo treatment and sign an informed consent form;

Exclusion Criteria

• Patients combined with pulmonary abscess, pulmonary fibrosis, active pulmonary tuberculosis, bronchiectasis or other lung diseases;
• Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac functional classification≥III, stroke, cerebral hemorrhage, etc.)；
• Patients with severe liver diseases (liver cirrhosis, portal hypertension, bleeding due to esophageal and gastric varices, etc.) or severe kidney diseases (renal dialysis, kidney transplantation, etc.)；
• Patients with confusion, various mental disorders, etc., who are unable to communicate normally;
• Pregnant and lactating women;
• Patients with heat phlegm pattern through TCM pattern differentiation；
• Patients participating in other clinical trials within 1 month prior to enrollment;
• Received TCM external treatment such as lung-benefiting moxibustion for 1 year;
• Patients allergic to moxibustion drugs, smoke, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

UNKNOWN

Sponsor Role: collaborator

Cuiling Feng

OTHER

Sponsor Role: lead

Responsible Party

Cuiling Feng

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

C Feng

Role: CONTACT

fengcuiling@sina.com

010-88325882

Other Identifiers

2024PHB342-001

Identifier Type: -

Identifier Source: org_study_id