Bailing Capsules with Guben Kechuan Granules for stable bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with stable bronchiectasis who meet entry criteria are assigned to receive either Bailing Capsules plus Guben Kechuan Granules alongside standard Western medical treatment or standard Western medical treatment alone for 24 weeks. The herbal regimen is given orally (four Bailing Capsules three times daily and one bag of Guben Kechuan Granules three times daily) with clinic visits and testing at baseline and prespecified follow-ups (for example at weeks 4, 12 and 24). Key outcomes include the number of acute exacerbations over the treatment period, lung function measures (FEV1/FVC), and monitoring for adverse events to characterize safety. Eligibility requires age 18–80, documented bronchiectasis with at least two exacerbations in the past year, no recent (past 4 weeks) respiratory infection or exacerbation, and ability to perform pulmonary function tests.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Huzhou Central Hospital
  Huzhou, Zhejiang, China Not yet recruiting
• Jinhua Central Hospital
  Jinhua, Zhejiang, China Not yet recruiting
• Yueqing People's Hospital
  Yueqing, Zhejiang, China Not yet recruiting
• Zhoushan Hospital
  Zhoushan, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Haibin Dai
• Email: haibindai@163.com
• Phone: （0571）87783759

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shuttle Walking Test to predict breathing problems after lung surgery

  This project will use a simple shuttle walking test before lung surgery to see if it predicts breathing problems and quality-of-life changes in people with chronic lung disease.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Not Required For This Country · NCT07102589

• Using entropy to detect sleep breathing problems in chronic lung disease

  This project will test whether entropy measurements from simple overnight oxygen and pulse recordings can find sleep-disordered breathing in adults with chronic lung conditions such as COPD, asthma, bronchiectasis, and interstitial lung disease.

  Recruiting University College, London · London · NCT07060079

• Using the Lung Sliding Index to distinguish common lung diseases

  This project will test whether the Lung Sliding Index (LSI) measured by bedside ultrasound can tell apart various lung conditions in adults with lung disease and in healthy volunteers.

  Recruiting Assiut University · Asyut · NCT06983366

• Using breath analysis to identify multiple lung diseases

  This study is testing if analyzing breath samples can help identify different lung diseases like lung cancer and COPD in a large group of 10,000 people.

  Recruiting ChromX Health · Guangzhou, Guangdong · NCT06528418

• Using smartphone technology to evaluate airway conditions

  This study is testing if smartphone technology can help check lung health and spot breathing problems in both healthy people and those with asthma or COPD.

  Recruiting at 2 sites Indiana University · Indianapolis, Indiana and 1 other locations · NCT06512064

• Thermotherapy for persistent bacterial lung infections

  This study is testing if regular heat therapy can help people with chronic lung infections get rid of stubborn bacteria that don’t respond to regular antibiotics.

  Recruiting Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Hellerup, Capital Region · NCT05351242

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.