Efficacy and Safety of Lung Dispersing, Turbid Descending and Gut Clearing Decoction on Clinically Stable Bronchiectasis (LUNG-CLEAR): A Multicenter, Randomized, Cross-over Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
时间窗: 6 months
Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
次要结局
- the frequency of bronchiectasis exacerbation(6 months)
- the time to the first bronchiectasis exacerbation(6 months)
- changes in forced expiratory volume in one second at month 6 compared with baseline(6 months)
- changes in sputum purulence score at month 6 compared with baseline(6 months)
- 24-hour sputum volume at month 6 compared with baseline(6 months)
- the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline(6 months)
研究者
Weijie Guan
associate professor
Guangzhou Institute of Respiratory Disease