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"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Length of Hospital Stay (days)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
test group
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.
干预措施: modified Ma Xing Shi Gan Decoction (Drug)
test group
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.
干预措施: 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 (Drug)
control group
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
干预措施: 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 (Drug)
结局指标
主要结局
Length of Hospital Stay (days)
时间窗: collected at baseline, 7 days, and 14 days post-treatment.
Number of days the patient remains hospitalized during the study period.
次要结局
- Traditional Chinese Medicine symptom score(collected at baseline, 7 days, and 14 days post-treatment)
- Dyspnea assessment(collected at baseline, 7 days, and 14 days post-treatment.)
- Mechanical Ventilation Requirement Rate(collected at baseline, 7 days, and 14 days post-treatment.)
- 6-Minute Walk Test Distance(Measured at baseline, 7 days, and 14 days.)
- Complete blood count (CBC)(Collected at baseline, 7 days, and 14 days.)
- C-reactive protein (CRP)(collected at baseline, 7 days, and 14 days post-treatment.)
研究者
Cuiling Feng
professor
Peking University People's Hospital