Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,100
- 主要终点
- Incidence rate of COPD
研究概览
简要总结
Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.
详细描述
Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Risk factors for chronic obstructive pulmonary disease. Having one item from a, b, and c (risk factors will be further optimized based on the screening results of high-risk populations):
- •smoking history (including previous and current smokers);
- •1 year or more of exposure to dust or chemical toxins;
- •Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
- •Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:
- •Cough (more than 3 months per year, continuous for 2 years or more);
- •Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
- •Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
- •The lung function test meets the following criteria: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 70% and FEV1 accounting for%<80% of the expected value.
- •Meets the diagnostic criteria for lung qi deficiency syndrome.
- •Age range from 18 to 80 years old.
- •Voluntarily participate in the study and sign an informed consent form.
排除标准
- •Pregnant and planned pregnancy, lactating women.
- •Dementia and various mental illness patients.
- •Other diseases with chronic cough, sputum production, or difficulty breathing.
- •Merge tumors.
- •Merge severe cardiovascular and cerebrovascular diseases.
- •Concomitant severe liver and kidney diseases.
- •Participants in clinical trials of other drugs.
- •Allergies to intervention drugs.
研究组 & 干预措施
Bufei Recipe
Bu Fei Fang: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
干预措施: Bufei Recipe (Drug)
Bufei Recipe placebo
The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.
干预措施: Bufei Recipe placebo (Drug)
结局指标
主要结局
Incidence rate of COPD
时间窗: Change from baseline in the number of people with COPD at month 24.
Incidence rate of COPD
次要结局
- COPD-PS(Change from baseline in COPD-PS score at months 6, 12, 18, and 24.)
- FEV1% pred(Change from baseline in FEV1% pred at months 12 and 24.)
- Clinical symptoms(Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.)
- FVC(Change from baseline in FVC at months 12 and 24.)
- FEV1(Change from baseline in FEV1 at months 12 and 24.)
- FEV1/FVC(Change from baseline in FEV1/FVC at months 12 and 24.)
- IPAG-Q(Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.)
- LFQ(Change from baseline in LFQ score at months 6, 12, 18, and 24.)
- CAT(Change from baseline in CAT score at months 6, 12, 18, and 24.)
- Biochemical indicators(Change from baseline in biochemical indicators at month 12 and 24.)
- SF-36(Change from baseline in SF-36 score at months 6, 12, 18, and 24.)