Effects of Chinese Medicine on Patients With Coal Worker's Pneumoconiosis: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- COPD assessment test (CAT)
研究概览
简要总结
This study aims to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of pneumoconiosis and to provide high-quality evidence for the prevention and treatment of pneumoconiosis.
详细描述
Pneumoconiosis refers to a group of occupational lung diseases characterized by diffuse fibrosis of the lung tissue. It is caused mainly by long-term inhalation and deposition of mineral dust, with varying levels of pathogenicity, into the lungs during occupational activities. Currently, there are a lack of effective therpy options for pneumoconiosis. Traditional Chinese Medicine (TCM) present a favorable prospect in treating pneumoconiosis. But the quality of the research was low. This needs to be further investigated by well-designed RCT to demonstrate the effect of TCM for pneumoconiosis.
In this study, a multicenter, randomized, double-blind, parallel controlled trial was designed. Patients with coal worker's pneumoconiosis were randomly divided into treatment group and control group by central random distribution system. For the treatment group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound based on TCM syndrome differentiation. For the control group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound placebo based on TCM syndrome differentiation. The intervention course is 52 weeks.The Six-minute Walking Distance (6MWD) and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score were taken as the primary outcomes, while the Modified British Medical Research Council Dyspnea Scale (mMRC) score, Pulmonary function, Clinical symptoms and signs questionnaire, the Hospital Anxiety and Depression Scale (HADS) score, and the Short Form 36 Health Survey Questionnaire (SF-36) score as the secondary outcomes, third-party data management and blind evaluation were adopted.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Pneumoconiosis (coal workers' pneumoconiosis) patients aged 18 to 75 years;
- •Comply with TCM syndrome differentiation standards;
- •Sign informed consent forms.
排除标准
- •Patients who do not get rid of the dust;
- •Patients with active tuberculosis, idiopathic pulmonary fibrosis, asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases;
- •Acute exacerbations occurred within 1 month before selection;
- •Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, HF New York Heart Association classes III to IV, stroke, cerebral hemorrhage);
- •Patients with severe liver and kidney disease (liver cirrhosis, portal hypertension, dialysis, kidney transplantation);
- •Tumor patients undergoing resection, radiotherapy and chemotherapy within 5 years before selection;
- •Patients with activity difficulties caused by neuromuscular diseases;
- •Patients with severe arthritis;
- •Patients with severe peripheral vascular disease;
- •Pregnant and lactating women;
- •Patients with severe cognitive and mental disorders;
- •Clinical investigators who are participating in other interventions within 1 month before selection.
研究组 & 干预措施
Chinese medicine compound combined with symptomatic treatments
Patients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments.
干预措施: Chinese medicine compound combined with symptomatic treatments (Drug)
Chinese medicine compound placebod combined with symptomatic treatments
Patients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments.
干预措施: Chinese medicine compound placebo combined with symptomatic treatments (Drug)
结局指标
主要结局
COPD assessment test (CAT)
时间窗: Change from baseline CAT scores at week 13, 26, 39, and 52.
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).
Six-minute walk distance (6MWD)
时间窗: Change from baseline 6MWD at week 13, 26, 39, and 52.
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity.
次要结局
- Clinical Symptoms and Signs Questionnaire(Change from baseline clinical symptoms and signs questionnaire scores at week 13, 26, 39, and 52.)
- modified Medical Research Council (mMRC)(Change from baseline mMRC scores at week 13, 26, 39, and 52.)
- MOS 36-Item Short-Form Health Survey (SF-36)(Change from baseline SF-36 scores at week 13, 26, 39, and 52.)
- Pulmonary Function(Changes from baseline to week 26, and 52 in pulmonary function parameters [FEV1 (L),FVC (L),FEV1/FVC (%),FEV1%,PEF (L/sec),DLCO (mL/mmHg/min)])
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline HADS scores at week 13, 26, 39, and 52.)