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

Recruiting now · Phase 4

Conditions studied: Bronchiectasis, COPD

In brief

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

Key facts

Study ID

NCT07114120

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

214

Starts

2025-07-14

Expected to finish

2027-12-30

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-80 years old, gender not limited;
• It conforms to the Western medical diagnosis of bronchiectasis;
• 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);
• 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;
• 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);
• Voluntarily participate in this clinical trial and sign the informed consent form.

You may not qualify if…

• Dry bronchiectasis mainly characterized by hemoptysis;
• Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
• Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
• 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;
• 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;
• Inability to swallow the research drug;
• Known allergy to the test drug;
• Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;
• Women or men of childbearing age refused to use contraceptive measures during the study period;
• Pregnant or lactating women;
• Any other factors that may not be suitable for participation in clinical research as determined by the researcher;
• In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;
• Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.

Where it is running

• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Huzhou Central Hospital — Huzhou, Zhejiang, China
• Jinhua Central Hospital — Jinhua, Zhejiang, China
• Yueqing People's Hospital — Yueqing, Zhejiang, China
• Zhoushan Hospital — Zhoushan, Zhejiang, China

Full record on ClinicalTrials.gov

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