Bronchiectasis
Conditions
Interventions
Experimental Group:Lifei Qingchang Granules + Postural Drainage
Placebo Group:TCM Placebo + Postural Drainage
Sponsors
First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-75 years old, regardless of gender; 2) Diagnosed with bronchiectasis by high-resolution CT (HRCT) scan; 3) In a stable phase of bronchiectasis; 4) Experienced at least one acute exacerbation of bronchiectasis in the past 12 months; 5) Classified as having Phlegm-Heat Obstructing Lungs syndrome according to Traditional Chinese Medicine (TCM) syndrome differentiation; 6) Able to sign the informed consent form and understand the study protocol.
Exclusion criteria
Exclusion criteria: 1) Allergic to any component of the investigational drug or placebo; 2) Co-morbidity with other severe systemic diseases (such as coronary heart disease, stroke, severe hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg), active gastric ulcer, uncontrolled diabetes (fasting venous blood glucose = 10 mmol/L), malignant tumors, abnormal liver and kidney function (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) level > 2 times the upper limit of normal; or creatinine (Cr) level > 2 times the upper limit of normal), etc.) or psychiatric disorders at screening; 3) Co-morbidity with asthma, allergic bronchopulmonary aspergillosis, or active pulmonary tuberculosis at screening; 4) Co-morbidity with COPD where COPD is the primary clinical manifestation (judged by the investigator); 5) Used inhaled, oral, or intravenous antibiotics within 4 weeks prior to enrollment; 6) Type II respiratory failure requiring long-term use of non-invasive mechanical ventilation or oxygen therapy (>10 hours/day); 7) History of drug abuse, psychotropic drug dependence, or alcohol abuse; 8) Smokers or those unable to stop smoking during the study; 9) Pregnant or lactating women, planning to become pregnant during the study, or disagreeing to use reliable contraceptive methods throughout the study; 10) Participated in other clinical trials within 3 months prior to enrollment; 11) Considered unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Quality of Life Bronchiectasis Questionnaire (Respiratory Domain) score at month 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in St. George's Respiratory Questionnaire (SGRQ) score at months 1, 2, and 3;Change from baseline in 24-hour sputum volume at months 1, 2, and 3;Change from baseline in Traditional Chinese Medicine (TCM) syndrome score at months 1, 2, and 3;Change from baseline in sputum characteristics (color and thickness) at months 1, 2, and 3;Change from baseline in forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) at month 3;Change from baseline in sputum bacteriological profile at month 3; | — |
Countries
China
Contacts
Public ContactZhimin Zhang
First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed