Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID07114120

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-08-11

214

Participants Needed

5

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

Z

ZhuZhou Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether the combination of Bailing Capsules and Guben Kechuan Granules can help treat adults with stable bronchiectasis. This study also aims to determine the safety of these combined treatments compared to the standard Western medical treatment. The main questions focus on whether this combination reduces the number of acute exacerbations in patients with stable bronchiectasis. Participants in the experimental group will take Bailing Capsules orally (four capsules three times a day) plus Guben Kechuan Granules (one bag three times a day) alongside standard Western medical treatment for 24 weeks. The control group will receive only the standard Western medical treatment. Both groups will be monitored throughout the study period, which includes visits at weeks 4, 12, 24, and 48, with symptom diaries kept by participants. During the study, participants will visit the clinic for checkups and tests to assess lung function at 12, 24, and 48 weeks. Researchers will measure the number of acute exacerbations during treatment and follow-up periods at 24 and 48 weeks. Safety and treatment adherence will be monitored throughout the trial, which lasts for nearly a year, allowing a comprehensive evaluation of treatment effects and patient health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Confirmed diagnosis of bronchiectasis by Western medical criteria
  • No acute exacerbation or respiratory infection in the past 4 weeks
  • At least two documented acute exacerbations in the past year
  • Able to perform pulmonary function tests with evidence of airflow limitation
  • Willingness to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Dry bronchiectasis mainly with hemoptysis
  • Bronchiectasis caused by cystic fibrosis or allergic bronchopulmonary aspergillosis
  • Other respiratory diseases like asthma, lung cancer, active tuberculosis, interstitial lung disease, pulmonary thromboembolism, or severe pneumonia
  • Serious heart, liver, kidney, digestive, or blood diseases as judged by researchers
  • Abnormal liver function exceeding specified limits
  • Inability to swallow the study drug
  • Known allergy to the study drug
  • Participation in other clinical trials or use of other research drugs/devices within 30 days before randomization
  • Refusal to use contraceptive measures during the study if of childbearing age
  • Pregnant or breastfeeding women
  • History of alcohol or drug abuse within the past year
  • Use of other traditional Chinese medicine treatments within 7 days before or during the study
  • Other factors deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 48 weeks

Participants receive Bailing Capsules combined with Guben Kechuan Granules along with standard Western medical treatment, or standard Western medical treatment alone.

Visits at 12, 24, and 48 weeks for pulmonary function assessments

Trial Site Locations

Total: 5 locations

1

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

2

Huzhou Central Hospital

Huzhou, Zhejiang, China, 313000

Not Yet Recruiting

3

Jinhua Central Hospital

Jinhua, Zhejiang, China, 321000

Not Yet Recruiting

4

Yueqing People's Hospital

Yueqing, Zhejiang, China, 325600

Not Yet Recruiting

5

Zhoushan Hospital

Zhoushan, Zhejiang, China, 316000

Not Yet Recruiting

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Research Team

H

Haibin Dai

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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