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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Traditional Chinese Medicine plus oral mucolytics \[ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid\]; 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 Optional formulae: bile arisaema 15g, polygala tenuifolia 15g, Mangnolia officinalis 10g, Fructus aurantii immaturus 10g; Magnetite 15-30g and reddle15-30g
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
Time frame: 6 months
the frequency of bronchiectasis exacerbation
the frequency of bronchiectasis exacerbation
Time frame: 6 months
the time to the first bronchiectasis exacerbation
the time to the first bronchiectasis exacerbation
Time frame: 6 months
changes in forced expiratory volume in one second at month 6 compared with baseline
changes in forced expiratory volume in one second at month 6 compared with baseline
Time frame: 6 months
24-hour sputum volume at month 6 compared with baseline
24-hour sputum volume at month 6 compared with baseline
Time frame: 6 months
changes in sputum purulence score at month 6 compared with baseline
changes in sputum purulence score at month 6 compared with baseline
Time frame: 6 months
the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline
the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline
Time frame: 6 months
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