Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis (LUNG-CLEAR)

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Bronchiectasis Adult; Traditional Chinese Medicine; Quality of Life; Exacerbation

Treatments: Combination Product: Traditional Chinese Medicine (TCM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03177889

GWJ-TCM-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Usual treatment

Sham Comparator group

Description:

oral mucolytics \[ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid\]

Treatment:

Combination Product: Traditional Chinese Medicine (TCM)

TCM treatment

Active Comparator group

Description:

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

Treatment:

Combination Product: Traditional Chinese Medicine (TCM)