Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

Study Overview
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Brief Summary
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Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.

Official Title
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Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Qingkepingchuan Granules
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria of AECOPD. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence 40 years old ≤ age ≤ 90 years old Patients who signed the informed consent form and volunteered to participate in the study Exclusion Criteria: Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases. Pregnant or lactating patients. Allergic to the clinical trial drugs.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Qingkepingchuan Granules
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Qingkepingchuan Granules+Conventional basic therapy | Drug: Qingkepingchuan Granules<br>* Qingkepingchuan Granules,Take it three times a day with water after meals.<br>|
| Other: control subjects<br>Conventional basic therapy | Other: conventional treatment<br>* Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese Medicine Symptoms Scale | Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes. | Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up | 
| COPD assessment test | Record changes in the patient's condition | Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up | 
| breathlessness measurement using the modified British Medical Research Council | Record changes in the patient's condition | Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walking test | Record changes in the patient's condition | Before the start of treatment, 2 weeks of treatment |