Evaluation of the Curative Effect and Health Economics of Bufei Yishen Prescription on Patients With Frequent Acute Exacerbation of COPD in Stable Stage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 848
- 主要终点
- The number of acute exacerbations
研究概览
简要总结
To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase.
详细描述
This study is based on a real world using a multicenter, randomized, double-blind, placebo-controlled trial.Based on a real-world multi-center, randomized, double-blind, placebo-controlled trial, this study will clinically observe patients with frequent acute exacerbations of chronic obstructive pulmonary disease in the stable phase.The study will evaluate the clinical efficacy and safety of Chinese medicine treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization and application of Chinese medicine therapy in chronic obstructive pulmonary disease.This study will scientifically evaluate the clinical efficacy and safety of TCM treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization of TCM evidence-based treatment in chronic obstructive pulmonary disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD at a stable stage.
- •Stable COPD patients with frequent acute exacerbation.
- •Age 40-80 years old.
- •The condition was stable 4 weeks before enrollment.
- •5 did not participate in other drug clinical studies within 1 month before enrollment.
- •At least 3 months of maintenance therapy with triple inhalation preparation was used before enrollment.
- •Washout period was 2 weeks before enrollment.
- •Voluntarily receive treatment and sign informed consent.
排除标准
- •complicity with other diagnosed and clinically significant respiratory diseases, including but not limited to: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary hypertension, pulmonary embolism, pneumothorax, pleural effusion, interstitial lung disease, or other active pulmonary diseases requiring intervention.
- •Patients with severe or acute cardiovascular and cerebrovascular diseases (acute cardiovascular and cerebrovascular events, malignant arrhythmias, unstable angina pectoris, cardiac function grade 3 or above, uncontrolled hypertension, etc.).
- •Complicated with severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, serious kidney disease including dialysis, kidney transplantation).
- •Any item of liver function index (ALT, AST) exceeds the upper limit of normal reference value by 1.5 times, and renal function index Scr exceeds the upper limit of normal reference value.
- •Tumor patients who have undergone surgical resection, radiotherapy and chemotherapy in the past five years.
- •Patients with mobility difficulties caused by severe osteoarthropathy, neuromuscular disease, and peripheral vascular disease.
- •Combined with absolute or relative prohibition of 6-minute walking test: such as resting heart rate > 120 beats/min, systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg; Or have limited activity to complete the 6-minute walking test.
- •Combined with cognitive or mental disorders.
- •Glucocorticoids were taken orally within 2 weeks before enrollment.
- •Had taken any Chinese medicine preparations (decoction, formula granule, proprietary Chinese medicine, etc.) prohibited during the study period according to the protocol within 2 weeks before enrollment.
- •People who are known to be allergic to therapeutic drugs.
- •Pregnant and lactating women, people who plan to become pregnant or cannot use effective contraceptive measures.
结局指标
主要结局
The number of acute exacerbations
时间窗: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.
The number of acute exacerbations
次要结局
- The number of AECOPD leading to hospitalization and death(Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.)
- Time of onset of the first AECOPD(Immediately after the intervention)
- Severity of AECOPD(Change from baseline severity of AECOPD at month 3, 6, 9and 12.)
- Lung function(Change from baseline lung function at month 3, 6, 9and 12.)
- Score for clinical signs and symptoms(Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.)
- 6-minute walking distance (6MWD)(Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.)
- Duration of AECOPD(Change from baseline duration of AECOPD at month 3, 6, 9and 12.)
- Case fatality rate(Up to month 12)
- The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)(Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.)
- The MOS item short fromhealth survey（SF-36）(Change from baseline SF-36 scale at month 3, 6, 9and 12.)