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RecruitingNot ApplicableNCT07131020

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

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

Sponsor

Henan University of Traditional Chinese Medicine

Enrollment

120 participants

Start Date

May 11, 2024

Study Type

INTERVENTIONAL

Conditions

Stable COPD Patients

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using a traditional Chinese medicine technique called Yifei Moxibustion — a heat-based therapy applied to specific points on the body — to see if it can improve immune function in people with stable COPD (chronic obstructive pulmonary disease), by analyzing changes in small molecules in the blood. **You may be eligible if...** - You have been diagnosed with stable COPD - Your COPD matches specific Traditional Chinese Medicine patterns related to lung or spleen or kidney qi deficiency - You are between 18 and 80 years old - You have signed informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have cognitive impairment, dementia, or a serious mental disorder - You have unstable chest pain or have recently had a heart attack - You have a history of fainting after exercise or bone/joint conditions that affect movement - You have pneumothorax, pleural effusion, pulmonary embolism, or a lung tumor - You are allergic to ingredients in the moxibustion powder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALYifei moxibustion

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.

DRUGConventional Western medicine treatment

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.

DRUGTCM syndrome differentiation treatment

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.

Locations(1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

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NCT07131020