Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

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 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]

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