Chronic Pseudomonas aeruginosa (PA) Infection in Bronchiectasis
Conditions
Interventions
Experimental Group:Standard treatment plus experimental intervention (Weijing Decoction combined with Beimu Gualou Powder): Oral administration of: Reed Rhizome () 30g Coix Seed () 15g Wax Gourd See
Control Group:Standard Treatment
Sponsors
The first teaching hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for chronic infection in bronchiectasis-associated PA; 2. Experienced more than 2 acute exacerbations of bronchiectasis in the past year, and received at least one course of anti-PA antibiotic treatment; 3. Discontinued any anti-PA antibiotics within the past 3 weeks prior to screening; 4. Pulmonary function FEV1% >50%; 5. Age between 18 and 80 years (inclusive of 18 and 80 years); 6. The subject has provided informed consent and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Confirmed as allergic bronchopulmonary aspergillosis; (2) Confirmed as other pulmonary structural destructive diseases, including but not limited to old pulmonary tuberculosis, interstitial lung disease, etc., or pulmonary space-occupying lesions; (3) Confirmed as other chronic airway inflammatory diseases, including but not limited to bronchial asthma, chronic obstructive pulmonary disease; (4) Within the past 1 year, required continuous inhalation or oral administration of bronchodilators/corticosteroids for more than 4 weeks; (5) Had fever within 1 week prior to the visit; (6) Started oxygen therapy or began using any of the following medications or therapies within 4 weeks prior to screening: azithromycin, hypertonic saline, mucolytics, bronchodilators, oral corticosteroids, or physical therapy; (7) Had massive hemoptysis (>300ml or requiring blood transfusion) within the past 6 months; (8) Has severe underlying diseases of the heart, liver, kidney, digestive, or hematopoietic systems, or severe mental disorders; (9) Serum BUN =1.5 ULN, or serum transaminases >3 ULN; (10) Has a history of long-term alcohol abuse or substance abuse; (11) Pregnant women, breastfeeding women, or women of childbearing age planning to conceive within the next 3 months; (12) Allergic constitution (allergic to two or more substances), or allergic to the investigational drug or its components; (13) Determined by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Time to First Acute Exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative Incidence of Acute Exacerbation in Bronchiectasis;Severity of Acute Exacerbation in Bronchiectasis;Change in Total TCM Symptom Score;Changes in TCM Symptom Scores; | — |
Countries
China
Contacts
Public ContactLi guiwei
The first teaching hospital of Tianjin University of TCM
Outcome results
None listed