Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

NCT06777472 | Not Yet Recruiting

• 1 other identifier: 2024PHB342-001
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

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

Keywords

asthma out of control; lung-benefiting moxibustion; Treating winter diseases in summer; RCT

Outcome Measures

Primary Outcomes (1)

• Annual number of flare-up of asthma

  Frequency

  1year

Secondary Outcomes (5)

• ACT and ACQ questionnaires

  Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.

• AQLQ scale

  Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.

• Pulmonary ventilation test and Diastolic test

  Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.

• FeNO

  Before treatment,and at 52, 104 weeks.

• Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets

  Before treatment,and at 7, 52, 59, 104 weeks.

Study Arms (2)

test group

EXPERIMENTAL

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.

Other: lung-benefiting moxibustion; Drug: The specific drug comes from "GINA (2024)"

control group

ACTIVE COMPARATOR

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.

Drug: The specific drug comes from "GINA (2024)"

Interventions

lung-benefiting moxibustion OTHER

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

test group

The specific drug comes from "GINA (2024)" DRUG

Refer to "GINA (2024)".

control group; test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cuiling Feng: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

C Feng

CONTACT

010-88325882; fengcuiling@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01