Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: lung-benefiting moxibustion; Drug: The specific drug comes from "GINA (2024)"

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: C Feng; Phone Number: 010-88325882; Email: fengcuiling@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows： 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.; 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; A kind of external treatment，the treatment theory is to treat winter diseases in summer.; Drug: The specific drug comes from "GINA (2024)"; Refer to "GINA (2024)".
Active Comparator: 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.	Drug: The specific drug comes from "GINA (2024)"; Refer to "GINA (2024)".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual number of flare-up of asthma	Frequency	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACT and ACQ questionnaires	ACT asthma control test A score of 25 indicates well-controlled asthma, 20-24 indicates partially controlled asthma, and 20 indicates uncontrolled.; Asthma Control Questionnaire <0.75 points indicates that asthma is completely controlled: 0.75-1.5 points indicates good control of asthma: >.15 points indicates that asthma is not well controlled	Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.
AQLQ scale	Asthma Quality of Life Questionnaire When calculating the overall score, the scores of each dimension are averaged to obtain a score between 0 and 7. The higher the score, worse the patient's quality of life. According to the AQLQ scoring criteria, a score above 5 indicates a relatively good quality of life, while a below 3 indicates a poor quality of life.	Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.
Pulmonary ventilation test and Diastolic test	Ventilation function test ml	Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.
FeNO	The fractional concentration of exhaled nitric oxide	Before treatment,and at 52, 104 weeks.
Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets	EO# x 10^9/L Ig E IU/mL percent of CD4+ cell、CD8+ cell 、CD4+/CD8+ cell	Before treatment,and at 7, 52, 59, 104 weeks.

Collaborators and Investigators

• Sponsor: Cuiling Feng
• Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: RCT; asthma out of control; lung-benefiting moxibustion; Treating winter diseases in summer
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 2024PHB342-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: have not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No