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Completed

NCT Number: NCT06143358

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.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing University of Chinese Medicine

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qingkepingchuan Granules

Drug

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

conventional treatment

Other

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

Primary outcomes

  1. Chinese Medicine Symptoms Scale

    Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up

    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.

  2. COPD assessment test

    Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up

    Record changes in the patient's condition

  3. breathlessness measurement using the modified British Medical Research Council

    Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up

    Record changes in the patient's condition

Secondary outcomes

  1. 6-minute walking test

    Time frame: Before the start of treatment, 2 weeks of treatment

    Record changes in the patient's condition

Sponsors and collaborators

Lead sponsor

Zhang Zhijie

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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