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RecruitingNCT07114120Updated Aug 11, 2025

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

A Phase 4 interventional study of Bailing Capsules in combination Guben Kechuan Granules in Bronchiectasis and COPD, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

03

In context

Bronchiectasis

368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's planned enrollment of 214 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
214 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Bailing Capsules in combination Guben Kechuan Granules

  • No intervention
    Control group

    standard Western medical treatment

Interventions

  • DrugBailing 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,)

    Also known as: Bailing Capsules, Guben Kechuan Granules

06

What researchers measure

Primary outcomes

  1. The number of acute exacerbations during treatment and follow-up

    Time frame: 24 weeks and 48 weeks

Secondary outcomes

  1. Pulmonary function

    FVC

    Time frame: 12, 24, 48 weeks

  2. Pulmonary function

    FEV1

    Time frame: 12, 24, 48 weeks

  3. Pulmonary function

    FEV1/FVC

    Time frame: 12, 24 48 weeks

  4. Pulmonary function

    TLC

    Time frame: 12, 24, 48 weeks

07

Study locations

1 of 5 sites recruiting
  • The Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
    Recruiting
  • Huzhou Central Hospital
    Huzhou, Zhejiang 313000, China
    • Wei Zhang · Contact
    Not yet recruiting
  • Jinhua Central Hospital
    Jinhua, Zhejiang 321000, China
    • Junwei Tu · Contact
    Not yet recruiting
  • Yueqing People's Hospital
    Yueqing, Zhejiang 325600, China
    • Jifa Li · Contact
    Not yet recruiting
  • Zhoushan Hospital
    Zhoushan, Zhejiang 316000, China
    • Huaiyu Zheng · Contact
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07114120
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
ZhuZhou Central Hospital, Jinhua Central Hospital, Shanghai Zhongshan Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Jul 14, 2025
Primary completion
Oct 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 11, 2025

Study contacts

Haibin Dai
Contact
haibindai@163.com
(0571)87783759

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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