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

NCT06143358 | Completed

• 1 other identifier: SY-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 6-minute walking test

  Before the start of treatment, 2 weeks of treatment

Study Arms (2)

treatment group

EXPERIMENTAL

Qingkepingchuan Granules+Conventional basic therapy

Drug: Qingkepingchuan Granules

control subjects

OTHER

Conventional basic therapy

Other: conventional treatment

Interventions

Qingkepingchuan Granules DRUG

Qingkepingchuan Granules,Take it three times a day with water after meals.

treatment group

conventional treatment OTHER

Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments

control subjects

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang Zhijie: lead

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Qingkepingchuan Granules

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

CN (1)