Yifei moxibustion to improve immune function in stable COPD via exosome miR-125b

Study on the Mechanism of Yifei Moxibustion in Enhancing Immune Function in Chronic Obstructive Pulmonary Disease Based on Plasma Exosomal miRNAs

This study will test whether Yifei moxibustion helps people with stable COPD by boosting immune function through changes in exosomal miR-125b and macrophage polarization.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Henan University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07131020 on ClinicalTrials.gov

What this trial studies

This randomized controlled study enrolls 90 patients with stable COPD and 30 healthy volunteers and randomizes patients to Yifei moxibustion, conventional Western medicine, or TCM syndrome-differentiation treatment for three months. Blood samples from patients and healthy volunteers will be analyzed for T cell subsets, immunoglobulins, exosomal microRNAs (including miR-125b), and markers of macrophage polarization. Techniques such as nanoparticle tracking and flow cytometry will be used to characterize exosomes and immune cell changes, and preliminary molecular targets will be explored. The design combines clinical immune readouts with mechanistic laboratory assays to link moxibustion treatment to potential molecular effects.

Who should consider this trial

Good fit: Adults aged 18–80 with stable COPD who meet the trial's TCM pattern criteria (lung qi deficiency, lung-spleen qi deficiency, or lung-kidney qi deficiency) and who can give informed consent are ideal candidates.

Not a fit: Patients with acute COPD exacerbations, serious unstable cardiac or other comorbid conditions, pregnant or lactating women, or those allergic to the moxibustion ingredients are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a non-drug complementary therapy that helps normalize immune responses and reduce airway inflammation in people with stable COPD.

How similar studies have performed: Some small studies report immunomodulatory effects of moxibustion, but using exosomal miR-125b to modulate macrophage polarization is a novel and not yet widely confirmed approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Zhengzhou, Henan

• the First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yang Xie, Doctor — the First Affiliated Hospital of Henan University of Chinese Medicine
• Study coordinator: Yang Xie, Doctor

Conditions Stable COPD Patients; COPD; Yifei moxibustion; miR-125b; macrophage polarization