Clinical Study on Guben Kechuan Granules Promoting Disease Recovery by Regulating Immune-Inflammatory Dysregulation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period

Обзор

Chronic Obstructive Pulmonary Disease (COPD) is one of the most common chronic airway diseases in China. Western medicine treatments have good clinical efficacy, but their effectiveness is limited in patients with Acute Exacerbation of COPD (AECOPD) during the peri-discharge period. Recurrent acute exacerbations remain an urgent clinical challenge to address. Traditional Chinese Medicine (TCM) has certain advantages in treating chronic airway diseases. Among them, Guben Kechuan Granules are widely used in respiratory diseases such as emphysema and COPD. However, high-level evidence for the use of Guben Kechuan Granules in patients with AECOPD during the peri-discharge period is currently lacking, and its mechanism of action has not been fully clarified.This study enrolled 126 patients with AECOPD during the peri-discharge period, who were randomly divided into the experimental group and the control group using a central randomization system. Both groups received treatment under the guidance of clinical guidelines, and the experimental group was additionally administered Guben Kechuan Granules. Follow-up assessments were conducted at 4 weeks, 8 weeks, and 12 weeks after treatment initiation, with efficacy indicators evaluated at 12 weeks. The primary efficacy endpoint was the improvement in Forced Expiratory Volume in 1 second (FEV1), while the secondary endpoints included the St. George's Respiratory Questionnaire (SGRQ), Modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT), and 6-Minute Walk Test (6MWT). This study aims to scientifically evaluate the clinical efficacy of Guben Kechuan Granules in treating AECOPD during the peri-discharge period and generate high-quality clinical evidence.By detecting COPD-related inflammatory indicators, T-cell subsets, transcriptomics, serum metabolomics, and lipidomics, the mechanism of action of Guben Kechuan Granules in this patient population will be clarified. The study intends to elucidate its molecular mechanism of inhibiting inflammatory cascades through metabolic regulation, and screen metabolite marker clusters that can predict the response to integrated TCM and Western medicine treatment, thereby providing objective evidence for individualized precision intervention strategies.

Вмешательства

• Препарат Guben Kechuan Granules group
  On the basis of receiving conventional treatment (referring to the 2025 GOLD Guidelines) and health education, patients in the Guben Kechuan Granules group were administered Guben Kechuan Granules. The granules were dissolved in warm water for oral administration at a dosage of 2 g each time, 3 times a day, for 12 consecutive weeks.
• Препарат Placebo Drug
  On the basis of receiving conventional treatment (referring to the 2025 GOLD Guidelines) and health education, patients in the control group were administered placebo. The placebo was dissolved in warm water for oral administration at a dosage of 2 g each time, 3 times a day, for 12 consecutive weeks.

Первичные конечные точки

• Degree of improvement in Forced Expiratory Volume in 1 second (FEV1) [Срок оценки: Collected at baseline, 2 weeks post-treatment, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment]

Вторичные конечные точки (4)

• St. George's Respiratory Questionnaire (SGRQ) score [Срок оценки: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment]
• Modified Medical Research Council (mMRC) Dyspnea Questionnaire [Срок оценки: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment]
• COPD Assessment Test (CAT) Questionnaire [Срок оценки: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment]
• 6-Minute Walk Test (6MWT) [Срок оценки: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment]

Критерии участия

Критерии включения

• Meet the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD), with lung function classified as Grade II-IV (Groups B and E).
• Be in the peri-discharge period of Acute Exacerbation of COPD (AECOPD).
• Conform to the Traditional Chinese Medicine (TCM) syndrome of spleen deficiency with excessive phlegm and insecure kidney qi.
• Aged 40-75 years, regardless of gender.
• Be an inpatient.
• Have no prior use of Guben Kechuan Granules.
• Be willing to participate in this study and sign the informed consent form.

Критерии исключения

• Have airflow limitation caused by other respiratory diseases such as bronchial asthma, bronchiectasis, pulmonary tuberculosis, and lung cancer.
• Have severe concurrent diseases of the heart, brain, liver, kidney, etc., which render the patient unable to cooperate with exercise.
• Have an impaired immune system or be receiving long-term ·immunosuppressive therapy.
• Be currently participating in another interventional clinical trial of drugs or medical devices.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07456813 · 2025PHB591-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗