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临床试验/NCT04694755
NCT04694755Unknown早期 1 期

An Exploratory Clinical Study on Reducing AECOPD of Chronic Respiratory Failure With COPD by Syndrome Differentiation

Henan University of Traditional Chinese Medicine0 个研究点目标入组 120 人开始时间: 2021年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
120
主要终点
Frequency of acute exacerbation

研究概览

简要总结

Taking the patients with chronic respiratory failure caused by COPD as the research object and the acute exacerbation of COPD as the main outcome index, the investigators hope to establish the syndrome differentiation and treatment scheme of COPD treated by traditional Chinese medicine, reduce the acute exacerbation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality, preliminarily explore the mechanism of action, and lay the foundation for further research.

详细描述

Chronic respiratory failure of chronic obstructive pulmonary disease belongs to the category of "lung distention", "asthma syndrome", "dyspnea" and "phlegm drink" in traditional Chinese medicine. According to traditional Chinese medicine, the pathology of this disease is mainly the dysfunction of lung ventilation. The basic pathogenesis is that the viscera are repeatedly affected by evil, the lung qi is damaged due to long-term disease, the lung function is damaged, the air mechanism is blocked, the application is publicized, the phlegm is turbid, the blood stasis is inevitable for a long time, and the lung qi is further damaged. The main clinical manifestations are shortness of breath, wheezing, shortness of breath, superficial shortness of breath and "drama of wheezing when moving", which may be accompanied by cough, expectoration, chest tightness, palpitation, lips, purple darkness, swelling of floating limbs, etc. The treatment of chronic respiratory failure patients with COPD can be significantly improved clinical symptoms such as shortness of breath and wheezing, reduce the number of acute exacerbations of patients, but there is still a lack of high-level evidence-based medicine research. Therefore, this project puts forward the hypothesis that "syndrome differentiation therapy can reduce AECOPD of COPD".It is proposed to adopt a multicenter, randomized, double-blind, placebo-controlled trial design, taking the patients with chronic respiratory failure caused by chronic obstructive pulmonary disease as the research object. The patients who meet the inclusion criteria, are divided into heart lung qi deficiency and lung kidney qi deficiency according to syndrome differentiation. The participants are randomly divided into the experimental group of 60 cases and the control group of 60 cases. The control group is given placebo treatment, and the experimental group is given Chinese medicine granules. The patients were followed up for 26 weeks. The main outcome indicators include the number of times of acute exacerbation of COPD, and the secondary outcome indicators include all-cause mortality, severity of acute exacerbation of COPD, clinical symptoms, CCQ score of COPD clinical questionnaire, quality of life score, dyspnea score, 6MWD, arterial blood gas analysis index, incidence and use time of mechanical ventilation, use time of oxygen therapy, serology index, health and economy Learning indicators, safety indicators, etc. To establish the TCM treatment scheme of chronic respiratory failure of COPD, reduce the acute aggravation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality rate, preliminarily explore the mechanism of action, and lay the foundation for further research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

It is jointly completed by the person in charge of the project, the drug preparation personnel and the statistician, and the two-level blind method is adopted. Blinding at the first level: that is to say, blinding is set for experimental Chinese medicine. The test drug and the control drug shall be packed uniformly; the second level shall be provided with blindness, that is, the number of the test drug packaging box shall be provided with blindness.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Heart lung qi deficiency syndrome placebo group

Placebo Comparator

Buyixinfei placebo was given.Tianjiang brand formula granules were used. One dose a day, two times orally, five days a week.

干预措施: Placebo (Drug)

Deficiency of lung and Kidney Qi placebo group

Placebo Comparator

Tonifying kidney and protecting lung prescription placebo was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week.

干预措施: Placebo (Drug)

Heart lung qi deficiency syndrome drugs group

Experimental

Buyixinfei formula was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week.

干预措施: Traditional Chinese medicine prescription (Drug)

Deficiency of lung and Kidney Qi drugs group

Experimental

The prescription of invigorating the kidney and protecting the lung was given. The drug was Tianjiang brand granule, one dose a day, two times orally, five days a week

干预措施: Traditional Chinese medicine prescription (Drug)

结局指标

主要结局

Frequency of acute exacerbation

时间窗: Up to week 52.

It will be assessed by frequencies of AECOPD-related hospitalizations.

Duration of acute exacerbation

时间窗: Up to week 52.

Duration of acute exacerbation will be recorded.

次要结局

  • PaCO2(Change from baseline ABG at week 13, 26, 39 and 52.)
  • Dyspnea(Change from baseline mMRC scores at week 4, 13, 26, 39 and 52.)
  • COPD assessment test (CAT)(Change from baseline CAT scores at week 4, 13, 26, 39 and 52.)
  • All-cause mortality(up to 52 weeks.)
  • Six-minute walking distance(6MWD)(Change from baseline 6MWD at week 4, 13, 26, 39 and 52)
  • FVC(Change from baseline FVC at week 26 and 52.)
  • PaO2(Change from baseline ABG at week 13, 26, 39 and 52.)
  • Duration of oxygen inhalation(Change from baseline Duration of oxygen inhalation at week 4, 13, 26, 39 and 52.)
  • Clinical symptoms and Signs(Change from baseline clinical symptoms assessment questionnaire scores at week 4, 13, 26, 39 and 52.)
  • CCQ(Change from baseline clinical symptom assessment questionnaire scores at week 4, 13, 26, 39 and 52.)
  • FEV1(Change from baseline FEV1 at week 26 and 52.)

研究者

发起方
Henan University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

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