Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Bronchiectasis; COPD

Treatments: Drug: Bailing Capsules in combination Guben Kechuan Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT07114120

2025-0537

Details and patient eligibility

About

The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are:

Does Bailing Capsules in combination Guben Kechuan Granules lower the number of acute exacerbation in patients with stable bronchiectasis? The safety of the combination of Bailing Capsules and Guben Kechuan Granules ? Researchers will compare the combination of Bailing Capsules and Guben Kechuan Granules to standard Western medical treatment to see if them works to treat stable bronchiectasis.

Participants will:

Take Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules ( three times a day, 1 bag each time )on the basis of standard Western medical treatment or only standard Western medical treatment for 24 weeks Visit the clinic for checkups and tests on 4, 12, 24, 48 weeks Keep a diary of their symptoms

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-80 years old, gender not limited;
2. It conforms to the Western medical diagnosis of bronchiectasis;
3. There has been no acute exacerbation or respiratory tract infection in the past 4 weeks. (Acute exacerbation is defined as the deterioration of three or more of the following six conditions: cough, changes in sputum volume, purulent sputum, breathing difficulties or exercise tolerance, fatigue or discomfort, and hemoptysis, lasting for more than 48 hours, and considered by the clinician to require treatment);
4. There have been at least two documented acute exacerbations in the past year, prescribed by doctors and diagnosed as signs and symptoms of respiratory tract infections;
5. Pulmonary function tests can be conducted, and there is evidence of airflow limitation when screening vital capacity (FEV1/FVC ratio <70%, and clinically stable at the time of entering the study);
6. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

1. Dry bronchiectasis mainly characterized by hemoptysis;
2. Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
3. Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
4. Combined with serious diseases of the heart, liver, kidneys, digestive system, blood system, etc., evaluated by the researcher, including but not limited to acute severe hepatitis, liver failure, liver cirrhosis, acute renal failure, acute myocardial infarction, heart failure, gastric perforation, gastrointestinal bleeding, gastric cancer, intestinal cancer, acute leukemia, acute aplastic anemia, etc., subject to the judgment of the researcher;
5. Abnormal liver function was found in the patient screening examination, with the following criteria: total bilirubin > 1.5×ULN; ALT > 3×ULN; AST > 3×ULN;
6. Inability to swallow the research drug;
7. Known allergy to the test drug;
8. Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;
9. Women or men of childbearing age refused to use contraceptive measures during the study period;
10. Pregnant or lactating women;
11. Any other factors that may not be suitable for participation in clinical research as determined by the researcher;
12. In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;
13. Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

214 participants in 2 patient groups

Experimental group

Experimental group

Description:

Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules (1 bag each time, three times a day) on the basis of standard Western medical treatment

Treatment:

Drug: Bailing Capsules in combination Guben Kechuan Granules

Control group

No Intervention group

Description:

standard Western medical treatment