Study on the Effects and Mechanisms of Modified Ma Xing Shi Gan Decoction in Treating Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Официальное название

Study on the Effects and Mechanisms of Modified Ma Xing Shi Gan Decoction in Treating Acute Exacerbations of Chronic Obstructive Pulmonary Disease Based on the "Lung-Large Intestine Mutual Interior-Exterior Relationship"

Обзор

This study adopted a multi-center, randomized, controlled trial design. Patients with acute exacerbation of chronic obstructive pulmonary disease who met the inclusion criteria were randomly assigned to the experimental group and the control group. Both groups were treated under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines. The experimental group was treated with modified Maxing Shigan Decoction. The modified Ma Xing Shi Gan Decoction was administered twice a day for 14 days. Taking the length of hospital stay (days) of the patients as the primary efficacy indicator, and the TCM syndrome score, dyspnea score (mMRC), 6-minute walk test and mechanical ventilation demand rate as the secondary efficacy indicators, the clinical efficacy of modified Maxing Shigan Decoction in the treatment of acute exacerbation of chronic obstructive pulmonary disease was evaluated.

Вмешательства

• Препарат modified Ma Xing Shi Gan Decoction
  The patient was given basic Western medical treatment combined with modified Ma Xing Shi Gan Decoction, orally twice a day for 14 days of intervention.
• Препарат The specific drug comes from "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised Edition 2023)" and the GOLD guidelines
  Under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines, basic Western medical treatment was given. The main types include third-generation cephalosporins, expectorants, short-acting anticholinergic drugs, and short-acting β2 receptor agonists, etc.

Первичные конечные точки

• Length of Hospital Stay (days) [Срок оценки: collected at baseline, 7 days, and 14 days post-treatment.]

Вторичные конечные точки (6)

• Traditional Chinese Medicine symptom score [Срок оценки: collected at baseline, 7 days, and 14 days post-treatment]
• Dyspnea assessment [Срок оценки: collected at baseline, 7 days, and 14 days post-treatment.]
• Mechanical Ventilation Requirement Rate [Срок оценки: collected at baseline, 7 days, and 14 days post-treatment.]
• 6-Minute Walk Test Distance [Срок оценки: Measured at baseline, 7 days, and 14 days.]
• Complete blood count (CBC) [Срок оценки: Collected at baseline, 7 days, and 14 days.]
• C-reactive protein (CRP) [Срок оценки: collected at baseline, 7 days, and 14 days post-treatment.]

Критерии участия

Критерии включения

• Patients meeting diagnostic criteria for COPD exacerbation, as defined by "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" ;
• Patients meeting the diagnostic criteria for phlegm-heat stagnation in the lungs syndrome within COPD, as referenced in the "Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine: Syndromes" and the 2020 International Guidelines for Clinical Practice of Traditional Chinese Medicine;
• Age > 18 years;
• Hospitalized patients;
• Voluntarily consent to treatment and sign an informed consent form.

Критерии исключения

• History of allergy to the study drug;
• History of active liver disease;
• Patients undergoing dialysis or with known moderate to severe renal impairment;
• Suspected or confirmed active systemic infection;
• Patients with host immune dysfunction, host immunodeficiency, or host immune reconstitution.

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: NCT07403032 · 2025PHB449-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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