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Study on the clinical efficacy and intestinal barrier function of the ‘method of clearing heat and resolving phlegm’ in patients with phlegm-heat congestion of the lungs during acute exacerbation of chronic obstructive pulmonary disease

Study on the clinical efficacy and intestinal barrier function of the ‘method of clearing heat and resolving phlegm’ in patients with phlegm-heat congestion of the lungs during acute exacerbation of chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091222
Enrollment
Unknown
Registered
2024-10-23
Start date
2021-06-20
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease (COPD)

Interventions

Control group:control group: the use of conventional Western medicine treatment.
combined treatment group:Combined treatment group: Combined treatment group, i.e. on the basis of the control group, add the formula for clearing heat and resolving phlegm to be taken orally, 1 dose p

Sponsors

Wuhu Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Enrolled patients need to meet the following conditions at the same time: 1. The Western medicine diagnostic criteria are consistent with the diagnostic criteria of the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) (2017 Update)". COPD: There is dyspnea, chronic cough and sputum, and a history of exposure to risk factors; the forced expiratory volume in the first second after inhalation of bronchodilators (FEV1/FVC) is less than 70% in pulmonary function test, that is, there is persistent airflow limitation, with or without cough, sputum, obvious shortness of breath and other symptoms; and other diseases are excluded. AECOPD: COPD patients' condition exceeds daily variation, respiratory symptoms worsen acutely, and drug treatment needs to be changed. Typical manifestations: worsening dyspnea, worsening cough, increased sputum volume, changes in sputum color and/or viscosity, and fever. Classification criteria: Grade I (no respiratory failure), respiratory rate 20-30 times/min; no auxiliary respiratory muscles used; no changes in mental consciousness; hypoxemia can be improved by nasal cannula/Venturi mask oxygen inhalation; no hypercapnia. Grade II (acute respiratory failure-no life-threatening), respiratory rate>30 times/min; auxiliary respiratory muscles used; no changes in mental consciousness; hypoxemia can be improved by Venturi mask oxygen inhalation; hypercapnia PaCO2 increased to 50-60 mmHg (1 mm Hg=0.133 kPa). 2. Patients with phlegm-heat obstructing the lungs according to TCM syndrome differentiation: refer to the "Guidelines for TCM Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2011 Edition)" to formulate the syndrome differentiation criteria for phlegm-heat obstructing the lungs. Main symptoms: cough or shortness of breath; a lot of sputum, yellow or white sticky, uncomfortable coughing up sputum; secondary symptoms: fever or thirst and preference for cold drinks; dry stool; red tongue, yellow or greasy tongue coating, rapid or slippery pulse. 3. Acute exacerbation time is less than 5 days. 4. No participation in other clinical studies of intervention measures within 1 month before enrollment. 5. Voluntarily accept the treatment plan and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the western medical diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease, and those whose Chinese medicine identification does not belong to the phlegm-heat congestion of the lungs syndrome. 2. Patients with combination of severe interstitial pulmonary fibrosis, pulmonary embolism, massive pleural effusion or pneumothorax. 3. Pregnant and lactating women. 4. Allergic or previously allergic to the components of the test drug. 5. Patients with severe infections in other parts of the body. 6. Patients with mental illness. 7. Patients with severe cardiovascular and cerebrovascular diseases, severe liver and renal insufficiency, digestive system diseases, haematological system and other primary diseases and malignant tumours. 8. Patients who refuse to participate in the study and refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Chinese Medicine Symptom Score;Points for gastrointestinal symptoms;

Secondary

MeasureTime frame
lung function;C-reactive protein;Neutrophil/lymphocyte ratio;citrulline;D-lactic acid value;intestinal flora;

Countries

China

Contacts

Public ContactXiao Ma

Wuhu Hospital of Traditional Chinese Medicine

maxiao15922302838@163.com+86 159 2230 2838

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026