Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

The purpose of this study is to evaluate the efficacy and safety of Lifei Qingchang Granules in the treatment of patients with stable bronchiectasis. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Researchers plan to enroll a total of 150 adult participants (aged 18-75) who have been diagnosed with stable bronchiectasis and experience at least one acute exacerbation in the past 12 months. Participants will be randomly assigned into two groups in a 1:1 ratio:

* The treatment group will receive Lifei Qingchang Granules along with standard postural drainage therapy. * The control group will receive a matching placebo along with standard postural drainage therapy.

The treatment period will last for 3 months. The main goal is to see if the treatment can improve patients' respiratory symptoms and overall quality of life.

Eligibility criteria

Qualifiers

Aged 18 to 75 years old, regardless of sex.

Diagnosed with bronchiectasis confirmed by High-Resolution Computed Tomography (HRCT) scan.

Bronchiectasis is currently in the stable phase.

Experienced at least one acute exacerbation of bronchiectasis within the previous 12 months.

Disqualifiers

Allergic to any ingredients of the investigational drug or placebo.

Comorbid with other severe systemic diseases (e.g., coronary heart disease, stroke, severe hypertension [systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg], active gastric ulcer, uncontrolled diabetes [fasting venous blood glucose ≥ 10 mmol/L], malignant tumors, abnormal liver or kidney function [AST, ALT, or GGT > 2 times the upper limit of normal; or serum creatinine > 2 times the upper limit of normal]) or psychiatric disorders.

Comorbid with asthma, allergic bronchopulmonary aspergillosis (ABPA), or active pulmonary tuberculosis.

Comorbid with chronic obstructive pulmonary disease (COPD) and presenting COPD as the primary clinical manifestation (as judged by the investigator).

Trial design

Treatments tested in this trial

  • Lifei Qingchang Granules
  • Placebo
  • Postural Drainage

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator