Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

Not Applicable

• Conditions: Quality of Life; Bronchiectasis Adult; Traditional Chinese Medicine; Exacerbation
• Interventions: Combination Product: Traditional Chinese Medicine (TCM)

• Registration Number: NCT03177889
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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 Timeline

• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-04
• Study First Posted: 2017-06-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-08
• Last Update Posted: 2020-02-11
• Study Start: 2021-12-31
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual treatment	Traditional Chinese Medicine (TCM)	oral mucolytics \[ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid\]
TCM treatment	Traditional Chinese Medicine (TCM)	Traditional Chinese Medicine plus oral mucolytics (described above); Agastache rugosus 5g, Scutellaria baicalensis 10g, Radix Puerariae 10g, Acorus tatarinowii schott 10g, Fructus Liquidambaris 5g, gypsum 15 g, Rheum officinale 5 g, Folium sennae 5 g, Codonopsis pilosula 10g, Radix Salviae Miltiorrhizae 10g, Lignum millettiae 10 g, Liquiritia glycyrrhiza 10 g

Primary Outcome Measures

Name	Time	Method
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline	6 months	Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

Secondary Outcome Measures

Name	Time	Method
the frequency of bronchiectasis exacerbation	6 months	the frequency of bronchiectasis exacerbation
the time to the first bronchiectasis exacerbation	6 months	the time to the first bronchiectasis exacerbation
changes in forced expiratory volume in one second at month 6 compared with baseline	6 months	changes in forced expiratory volume in one second at month 6 compared with baseline
changes in sputum purulence score at month 6 compared with baseline	6 months	changes in sputum purulence score at month 6 compared with baseline
24-hour sputum volume at month 6 compared with baseline	6 months	24-hour sputum volume at month 6 compared with baseline
the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline	6 months	the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline