Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 216
- 主要终点
- The frequency of bronchiectasis exacerbation
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.
详细描述
Bronchiectasis is a common and frequently occurring respiratory disease, with more hospitalization rate and mortality, poor quality of life and heavy financial burden. The main clinical manifestations are persistent or recurrent cough, expectoration, sometimes accompanied by hemoptysis, which can cause respiratory dysfunction and chronic pulmonary heart disease. There are some randomized controlled trials of TCM for bronchiectasis, and have the effect in the treatment of bronchiectasis, reducing the number of acute aggravation and alleviating dyspnea. However, some TCM interventions lack comprehensive syndrome differentiation and the placebo control.
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy to evaluate the effectiveness of TCM on patients with clinically stable bronchiectasis. 216 subjects will be randomly assigned to one therapies (TCM treatments based on syndrome differentiation) and the other therapy (placebo of TCM treatment) for 24 weeks. After the treatment period, the subjects will be followed up for 24 weeks. The primary outcomes include the frequency of bronchiectasis exacerbation, and the secondary outcomes include quality of life (SGRQ, LCQ, QOL-B), pulmonary function, safety observation index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of clinically stable bronchiectasis
- •Age between 18 and 80 years
- •Syndrome differentiation meets criteria of syndrome of Qi deficiency of lung and phlegm-turbidity obstructing the lung, syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung
- •Without participations in other interventional trials in the previous one month
- •With the informed consent signed
排除标准
- •Current respiratory disorders other than bronchiectasis (e.g. COPD,bronchial asthma, lung cancer,active tuberculosis, Interstitial lung disease, pulmonary thromboembolic, or Other patients who have an impact on the observation of disease)
- •Patients with severe cardiovascular disease (e.g. Acute myocardial infarction,Acute heart failure)
- •Severe liver disease(e.g.Active phase of hepatitis, Cirrhosis, Severe impairment of liver function by portal hypertension)
- •Severe renal disease(e.g. renal transplant, dialysis)
- •Patients with large hemoptysis in the last month
- •Pregnant and lactating women
- •Insanity, Dementia, and all kinds of Psychosis
- •Smoking patients (Years of smoking10/ package year)
- •Participating in other clinical trials with other interventions;
- •Allergic to the used medicine.
研究组 & 干预措施
TCM
Patients in this group will receive two types of TCM treatment, which are Bufei Huatan granule, Yifei Qinghua granule. The herbal extract twice daily for 24 weeks for lower dosage. The two granules are corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
干预措施: Bufei Huatan granule (Drug)
TCM
Patients in this group will receive two types of TCM treatment, which are Bufei Huatan granule, Yifei Qinghua granule. The herbal extract twice daily for 24 weeks for lower dosage. The two granules are corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
干预措施: Yifei Qinghua granule (Drug)
placebo TCM
Patients in this group will be given two placebo TCM treatment, which are which are placebo Bufei Huatan granule, placebo Yifei Qinghua granule, corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
干预措施: Placebo Bufei Huatan granule (Drug)
placebo TCM
Patients in this group will be given two placebo TCM treatment, which are which are placebo Bufei Huatan granule, placebo Yifei Qinghua granule, corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
干预措施: Placebo Yifei Qinghua granule (Drug)
结局指标
主要结局
The frequency of bronchiectasis exacerbation
时间窗: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.
The bronchiectasis exacerbations often result in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of bronchiectasis exacerbations over time.
次要结局
- The time to the first bronchiectasis exacerbation(Week 24 of the treatment phase.)
- Changes in Forced expiratory volume in one second(Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.)