Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHenan University of Traditional Chinese Medicine
About this trial
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with severe AECOPD.;
Age 40-80 years old;
Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
Voluntarily accept the treatment and sign the informed consent form;
Disqualifiers
Pregnant and lactating women.
delirious, dementia, various mental patients and other people who cannot communicate normally.
Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
Trial design
Design model
Parallel
Treatments tested in this trial
Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe
DrugOn the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo
DrugOn the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
Treatment groups
468 Participants
are divided into 2 treatment groupsGroup A: Chinese medicine granules plus western medicine treatmentExperimental treatment 1 intervention
Group B: Chinese medicine granules placebo plus western medicine treatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment failure rate
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
Time frame
During the 10 days treatment period and the 3 months follow-up period.Secondary outcomes
1
The COPD Assessment Test(CAT)
The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.
Time frame
Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.2
The number and severity of acute exacerbations
The number and severity of acute exacerbations during the follow-up period.
Time frame
Within 3 months of follow-up period.3
Readmission rate of acute exacerbations
The number of readmissions due to acute exacerbations during the follow-up period.
Time frame
Within 3 months of follow-up period.4
The time to the first exacerbation of COPD
The time to the first COPD exacerbation during the study period.
Time frame
Within 3 months of follow-up period.Locations
Sponsors and contacts
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Henan University of Traditional Chinese Medicine
Lead sponsor
Peking University Third Hospital
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Collaborator
Shenzhen Hospital of Southern Medical University
Collaborator
Qingdao Haici Hospital
Collaborator
Xiangyang Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov
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