Bronchiectasis Adult, Exacerbation, Quality of Life, Traditional Chinese Medicine
Conditions
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.
Interventions
COMBINATION_PRODUCTTraditional Chinese Medicine (TCM)
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
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| the frequency of bronchiectasis exacerbation | 6 months | the frequency of bronchiectasis exacerbation |
| changes in sputum purulence score at month 6 compared with baseline | 6 months | changes in sputum purulence score 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 |
| 24-hour sputum volume at month 6 compared with baseline | 6 months | 24-hour sputum volume at month 6 compared with baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes in sputum hydrogen peroxide level at month 6 compared with baseline | 6 months | changes in sputum hydrogen peroxide level at month 6 compared with baseline |
| Changes in sputum superoxide dismutase activity at month 6 compared with baseline | 6 months | Changes in sputum superoxide dismutase activity at month 6 compared with baseline |
| changes in sputum catalase activity at month 6 compared with baseline | 6 months | changes in sputum catalase activity at month 6 compared with baseline |
| changes in sputum total antioxidant capacity at month 6 compared with baseline | 6 months | changes in sputum total antioxidant capacity at month 6 compared with baseline |
| changes in airway resistance measured at 5 Hz at month 6 compared with baseline | 6 months | changes in airway resistance measured at 5 Hz at month 6 compared with baseline |
| changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline | 6 months | changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline |
| changes in sputum microbiota composition at month 6 compared with baseline | 6 months | changes in sputum microbiota composition at month 6 compared with baseline |
| Changes in AX at month 6 compared with baseline | 6 months | Changes in AX at month 6 compared with baseline |
Contacts
Primary ContactWei-jie Guan, Ph.D.
Backup ContactZhi-min Zhang, M.D.
Outcome results
None listed