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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Qingkepingchuan Granules; Other: conventional treatment

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meet the diagnostic criteria of AECOPD.
2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
3. 40 years old ≤ age ≤ 90 years old
4. Patients who signed the informed consent form and volunteered to participate in the study

Exclusion Criteria:

1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
3. Pregnant or lactating patients.
4. Allergic to the clinical trial drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: Zhang Zhijie

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SY-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No