Tests Bailing Capsules with Guben Kechuan Granules in stable bronchiectasis
Tests two traditional Chinese medicines added to standard care in adults with stable bronchiectasis.
Plain-language title generated from the registry record
Registry title: Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
Key facts
- Where
- Hangzhou, Huzhou, Jinhua, Yueqing, and Zhoushan, ChinaSee the 5 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07114120, who can take part
Where in China
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Huzhou Central HospitalHuzhou, ChinaNot yet recruiting
- Jinhua Central HospitalJinhua, ChinaNot yet recruiting
- Yueqing People's HospitalYueqing, ChinaNot yet recruiting
- Zhoushan hospitalZhoushan, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07114120
- Record updated
- 11 August 2025
- Original description
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:Read full original descriptionShow less
Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
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
Inclusion: 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.
Exclusion: Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.); Inability to swallow the research drug; Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization; Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period; Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, 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; Known allergy to the test drug; In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse; 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; Women or men of childbearing age refused to use contraceptive measures during the study period; Dry bronchiectasis mainly characterized by hemoptysis; Pregnant or lactating women; Any other factors that may not be suitable for participation in clinical research as determined by the researcher.