Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Phlegm-Heat Obstructing Lung Syndrome)
Conditions
Interventions
Control Group:Basic Western treatment + Ten-Ingredient Lung-Tonifying Pill simulator (Form: Water pill
Specification: 0.67g per 100 pills, 2g per bag): Crush and take orally, 2g (1 bag) with warm water, three times daily
Experimental Group:Basic Western treatment + Ten-Ingredient Lung-Tonifying Pill (Form: Water pill
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 40-75 years; (2) Meet COPD diagnostic criteria in 2026 GOLD report, mild/moderate AECOPD; (3) Current acute episode duration =5 days; (4) Meet TCM phlegm-heat obstructing lung syndrome criteria; (5) Voluntary participation with informed consent.
Exclusion criteria
Exclusion criteria: (1) Comorbidities with asthma, bronchiectasis, etc.; (2) NYHA cardiac function class =3; (3) Severe cardiovascular, urinary, digestive, hematopoietic system diseases or malignancies; (4) Known/suspected alcohol/drug abuse; (5) Abnormal liver/kidney function (ALT/AST/BUN >1.5×ULN, Cr >ULN); (6) Current systemic corticosteroid use; (7) Severe physical/cognitive impairment; (8) Drug allergies; (9) Pregnancy plans/pregnant/lactating women; (10) Participation in other drug trials within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in comprehensive assessment scale scores for dyspnea, cough, and sputum on day 7±1 of treatment compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in comprehensive assessment scale scores for dyspnea, cough, and sputum compared to baseline on Day 3±1 of treatment.;Improvement in individual symptom severity data for dyspnea, cough, and sputum during the trial, as assessed by a comprehensive assessment scale.;The proportion of participants during the trial period whose comprehensive assessment scores for dyspnea, cough, and sputum production returned to the pre-acute exacerbation (stable phase) scores for COPD.;The proportion of participants who recovered to 0 points on the comprehensive assessment scale for shortness of breath, cough, and phlegm during the trial.;Modified Medical Research Council (MRC) Dyspnea Scale;Chronic Obstructive Pulmonary Disease (COPD) Patient Self-Assessment Test Questionnaire Scoring;TCM Phlegm-Heat Obstructing Lung Syndrome Score;The blood oxygen saturation (SpO2) at rest without supplemental oxygen.;Prognosis (Remission, Exacerbation, No change, Hospitalization, Complications);6-minute walk test distance;Pulmonary Function (FEV1/FVC, etc.);Body Mass Index, Degree of Airflow Obstruction, Dyspnea Index, and Exercise Capacity Index;Immune Parameters: IL-6, CD4+, CD8+, IgA, IgG, IgM;Inflammatory Markers: WBC, NLR, CRP; | — |
Countries
China
Contacts
Public ContactFan Maorong
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed