Clinical Study on Reducing Recurrent Attacks of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie Based on "winter Disease Being Cared in Summer"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,312
- 试验地点
- 1
- 主要终点
- Asthma part：Number of acute attacks per year
研究概览
简要总结
Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.
详细描述
Asthma and Chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases, and their recurrent episodes or acute exacerbations are the main reasons for the decline in patients' quality of life and heavy economic burden. Based on the of "winter disease being cared in summer", traditional Chinese medicine (TCM) has a long history and wide application in preventing and treating the recurrence of chronic air diseases, with obvious advantages of combining TCM and Western medicine. However, there is a lack of integrated TCM and Western medicine technical schemes for chronic airway based on high-level evidence-based evidence. The Shu Fei Tie developed by our project team is a medical institution preparation that has been used clinically for a long. Therefore, this study conducted a multi-center, large-sample, randomized controlled clinical study of the Shu Fei Tie to prevent the recurrence of asthma and COPD. The study subjects were patients in the remission period of asthma (1332 cases) and the stable period of COPD (980 cases) On the basis of treatment guided by the guidelines, the experimental group was given the Shu Fei Tie, and the control group was given a placebo of theu Fei Tie. The treatment started 10 days before the " the first Fu" and was conducted every 10 days, A total of 5 times, Each treatment lasted 6-8 hours, and the follow-up period was 45 weeks, for a total of 3 cycles (3 years). The outcome indicators were the number of acute attacks per year for asthma and the number of acute exacerbations per year for COPD. The secondary outcome indicators for asthma included Asthma Control Test (ACT) score, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). For COPD, the secondary outcome indicators included clinical symptom scores and lung function. This study scientifically evaluated the clinical efficacy and safety of the Shu Fei Tie reducing the recurrence of chronic airway diseases, identified the advantageous population, elucidated the mechanism of efficacy, and established a technical scheme for preventing and treating the recurrence of chronic airway diseases with the Shu Fei Tie.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Meets the diagnostic criteria for asthma/COPD(Group E in the GOLD classification); ② Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
- •The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
排除标准
- •Patients with other pulmonary diseases (lung abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis，etc);
- •Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, heart grade 3 or above, stroke, cerebral hemorrhage, etc.);
- •Patients with severe liver diseases (liver cirrhosis, portal hypertension, and caused by esophageal and gastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.);
- •Patients with impaired consciousness or various illnesses who cannot communicate normally; ⑤Pregnant and lactating women; ⑥Patients who are participating in other clinical trials within one month prior to enrollment; ⑦Patients who have received acupuncture or other traditional Chinese medicine external treatments within the past year; ⑧ Patients who are allergic to external patches
研究组 & 干预措施
Shu Fei Tie group for Asthma/COPD
Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie
干预措施: Shu Fei Tie (Drug)
Shu Fei Tie Placebo group for Asthma/COPD
Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie Placebo
干预措施: Shu Fei Tie placebo (Drug)
结局指标
主要结局
Asthma part：Number of acute attacks per year
时间窗: Count once a year for three consecutive years
Record the number of acute attacks per year for each patient, and evaluate the effect of the lung-clearing patch on reducing the number of acute attacks
COPD part：The number of acute exacerbations per year
时间窗: Count once a year for three consecutive years
Record the number of acute exacerbations in patients per year to evaluate the treatment effect of Shu Fei Tie on patients.
COPD part：the interval between successive acute exacerbations
时间窗: at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
COPD part:the number of rehospitalizations within a year
时间窗: Count once a year until the end of the 3-year cycle
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
次要结局
- Asthma part：Asthma Quality of Life Questionnaire(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：Frequency of anti-inflammatory and analgesic use(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：Asthma Control Questionnaire(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：readmission rate(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：Forced expiratory volume in the first second(Before treatment, at weeks 52, 104, and 156 of treatment)
- Asthma part：Asthma Control Test(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：Disease Control Rate(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- Asthma part：Peak expiratory flow(Before treatment, at weeks 52, 104, and 156 of treatment)
- Asthma part：Fractional exhaled nitric oxide(Before treatment, at weeks 52, 104, and 156 of treatment)
- Asthma part：clinical symptoms and signs questionnaire(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- COPD part：clinical symptoms and signs questionnaire(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- COPD part：mMRC(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- COPD part：CAT(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- COPD part：SGRQ(at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year))
- COPD part：Forced expiratory volume in the first second(Before treatment, at weeks 52, 104, and 156 of treatment)
- COPD part：Forced Vital Capacity(Before treatment, at weeks 52, 104, and 156 of treatment)
- COPD part：Forced expiratory volume in the first Second Percentage of predicted value(Before treatment, at weeks 52, 104, and 156 of treatment)
- COPD part：Maximal Mid-Expiratory Flow(Before treatment, at weeks 52, 104, and 156 of treatment)
- COPD part：Forced expiratory flow at 50% of FVC exhaled(Before treatment, at weeks 52, 104, and 156 of treatment)
- COPD part：Forced expiratory flow at 75% of FVC exhaled(Before treatment, at weeks 52, 104, and 156 of treatment)