Brief Title
Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis
Official Title
Efficacy and Safety of Lung Dispersing, Turbid Descending and Gut Clearing Decoction on Clinically Stable Bronchiectasis (LUNG-CLEAR): A Multicenter, Randomized, Cross-over Trial
Brief Summary
Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Here, the investigators will explore the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.
Detailed Description
Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Symptomatic treatment may be effective and safe for ameliorating respiratory symptoms and hindering disease progression of bronchiectasis. Here, the investigators have explored the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.
Study Type
Interventional
Primary Outcome
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
Secondary Outcome
the frequency of bronchiectasis exacerbation
Condition
Bronchiectasis Adult
Intervention
Traditional Chinese Medicine (TCM)
Study Arms / Comparison Groups
Usual treatment
Description: oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid]
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Combination Product
Estimated Enrollment
80
Start Date
December 31, 2021
Completion Date
December 31, 2023
Primary Completion Date
August 31, 2023
Eligibility Criteria
Inclusion Criteria: - aged between 18 and 75 years; - remained clinically stable (respiratory symptoms and lung function parameters not exceeding normal daily variations) for 4 consecutive weeks; - no acute upper respiratory tract infections within 4 weeks; - 1 or more BEs within the previous 2 years Exclusion Criteria: - Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction); - Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis; - Concomitant chronic obstructive pulmonary disease as the predominant diagnosis; - Treatment with inhaled, oral or systemic antibiotics within 4 weeks; - Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation; - Females during lactation or pregnancy; - Poor understanding or failure to properly operate the instrument; - Participation in other clinical trials within 3 months.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Wei-jie Guan, MD, +86-13826042052, [email protected]
Administrative Informations
NCT ID
NCT03177889
Organization ID
GWJ-TCM-2017
Responsible Party
Principal Investigator
Study Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Sponsor
Wei-jie Guan, MD, Study Chair, First Affiliated Hospital of Guangzhou Medical University
Verification Date
February 2020