Study on the Mechanism of Yifei Moxibustion Improving Immune Function in COPD Based on Plasma Exosome miRNAs

NCT07131020 | Recruiting DMC

• 1 other identifier: Yifei moxibustion for COPD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopted a randomized controlled design, enrolling 90 patients and 30 healthy volunteers. The patients were randomly divided into the Yifei Moxibustion group, the conventional Western medicine treatment group, and the TCM syndrome differentiation treatment group, and were treated for 3 months. Peripheral venous blood was collected from both the healthy volunteers and the patients to observe indicators such as T cell subsets and immunoglobulins, to evaluate the effect of Yifei Moxibustion on improving immune function. The regulation of target genes by exosomes and potential action targets and molecular mechanisms were preliminarily verified through techniques such as nanoparticle tracking technology and flow cytometry.

Conditions

Stable COPD Patients

Keywords

COPD; Yifei moxibustion; miR-125b; macrophage polarization

Outcome Measures

Primary Outcomes (2)

• The level of plasma exosomal miR-125b

  The regulatory effect of Yifei moxibustion on miR-125b was evaluated through the detection of peripheral venous blood.

  Before treatment and 3 months after treatment

• T-cell subsets and immunoglobulin levels

  By detectingCD3+、CD4+、CD8+、CD4+/CD8+、Th17、Treg、Th17/Treg 、IgG、IgA、IgM, the regulatory effect of Yifei moxibustion on the immune function of COPD was evaluated.

  Before treatment and 3 months after treatment

Secondary Outcomes (9)

• Clinical Symptoms and Signs Assessment Questionnaire Assessment

  Before treatment, the first month, the second month and the third month

• The modified Medical Research Council (mMRC) scale

  Before treatment, the first month, the second month and the third month

• lung function

  Time Frame：Before treatment and 3 months after treatment

• Six-Minute Walk Distance（6MWD）

  Before treatment, the first month, the second month and the third month

• The COPD Assessment Test (CAT)

  Before treatment, the first month, the second month and the third month

Study Arms (3)

Yifei moxibustion group

EXPERIMENTAL

The patients in the Yifei Moxibustion group are treated with conventional Western medicine combined with Yifei Moxibustion.

Behavioral: Yifei moxibustion

Conventional Western medicine treatment group

ACTIVE COMPARATOR

The patients in the conventional Western medicine treatment group receives standard Western medication therapy.

Drug: Conventional Western medicine treatment

TCM syndrome differentiation treatment group

ACTIVE COMPARATOR

Patients in the TCM syndrome differentiation treatment group receives TCM pattern-based therapy in addition to conventional Western medical treatment.

Drug: TCM syndrome differentiation treatment

Interventions

Yifei moxibustion BEHAVIORAL

The conventional Western medicine treatment is based on the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the 2021 Chinese Thoracic Society guidelines for the diagnosis and management of chronic obstructive pulmonary disease. Bronchodilators, inhaled corticosteroids, or a combination therapy are administered.The Yifei moxibustion is applied from the Dazhui to Yaoshu acupoints along the Governor Vessel. Ginger juice is spread over the treatment area, followed by sprinkling moxa powder and covering with mulberry bark paper. A 2.5 cm thick layer of ginger paste and a 3 cm thick layer of moxa wool are then placed on the mulberry bark paper. The moxa wool is ignited and allowed to burn out naturally, being replaced every 30 minutes. After 90 minutes, the ginger paste is removed. The treatment is performed once every 15 days, with 6 sessions constituting one course of treatment, totaling 3 months.

Yifei moxibustion group

Conventional Western medicine treatment DRUG

The conventional Western medicine treatment is based on the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the 2021 Chinese Thoracic Society guidelines for the diagnosis and management of chronic obstructive pulmonary disease. Bronchodilators, inhaled corticosteroids, or a combination therapy are administered.

Conventional Western medicine treatment group

TCM syndrome differentiation treatment DRUG

The conventional Western medicine treatment followes the same protocol as described above. The diagnosis of TCM pattern-based therapy is made in accordance with the TCM Syndrome Diagnostic Criteria for Chronic Obstructive Pulmonary Disease issued by the Pulmonary Disease Committee of the Internal Medicine Branch, China Association of Chinese Medicine and the treatment is based on the 2019 Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease issued by the China Association of Chinese Medicine.

TCM syndrome differentiation treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the diagnostic criteria for stable chronic obstructive pulmonary disease;
• Patients who meet the TCM diagnostic criteria for lung qi deficiency, lung-spleen qi deficiency, and lung-kidney qi deficiency; ③ Aged 18 to 80 years old; ④ Voluntarily signed the informed consent form.

You may not qualify if:

• Pregnant and lactating women;
• Patients with cognitive impairment, confusion, dementia, or various mental disorders;
• Patients with unstable angina pectoris or acute myocardial infarction;
• Patients with a history of syncope after exercise or bone and joint diseases that affect exercise; ⑤ Patients with pneumothorax, pleural effusion, pulmonary embolism, or tumors;
• Patients known to be allergic to the ingredients of the moxibustion powder.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450056, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Xie, Doctor

  the First Affiliated Hospital of Henan University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Xie, Doctor

CONTACT

13526621325; xieyanghn@163.com

Yanmin Shi, Master

CONTACT

18838906711

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 19, 2025
• Study Start: May 11, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)