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

NCT ID: NCT07114120

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2027-12-30

Brief Summary

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

Conditions

Bronchiectasis; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Bailing Capsules in combination Guben Kechuan Granules

Intervention Type: DRUG

Bailing Capsules (four capsules each time, three times a day) in combination Guben Kechuan Granules (1 bag each time，three times a day,)

Control group

standard Western medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bailing Capsules in combination Guben Kechuan Granules

Bailing Capsules (four capsules each time, three times a day) in combination Guben Kechuan Granules (1 bag each time，three times a day,)

Intervention Type: DRUG

Other Intervention Names

Bailing Capsules; Guben Kechuan Granules

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZhuZhou Central Hospital

OTHER

Sponsor Role: collaborator

Jinhua Central Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Affiliated Yueqing Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Huzhou Central Hospital

Huzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Yueqing People's Hospital

Yueqing, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Zhoushan Hospital

Zhoushan, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Haibin Dai

Role: CONTACT

haibindai@163.com

（0571）87783759

Facility Contacts

Haibin Dai

Role: primary

HREC2013@126.com

0571-87783759

Wei Zhang

Role: primary

Junwei Tu

Role: primary

Jifa Li

Role: primary

Huaiyu Zheng

Role: primary

Other Identifiers

2025-0537

Identifier Type: -

Identifier Source: org_study_id