Evaluating the Efficacy and Safety of Modified Qing-Zao-Jiu-Fei Decoction on Pneumoconiosis Patients: A Randomized, Double-blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20.
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to investigate the beneficial efficacy and safety of Chinese medicine formula Modified Qing Zao Jiu Fei Decoction (MQZJFD) on pneumoconiosis patients. Participants will be randomized into one of the two groups (MQZJFD treatment group or placebo control group), and both undergo a consultation process by the Chinese Medicine practitioner (CMP). Eligible participants will be randomized and receive either MQZJFD granules or placebo granules for 16 weeks followed by post-treatment visits at week 20. The study will last for 20 weeks with a treatment period of 16 weeks plus a follow-up period of 4 weeks.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)
A chinese medicine formular
干预措施: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD) (Drug)
Placebo
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20.
时间窗: Baseline, weeks 4, 8, 12, 16 and 20.
The 6MWT, developed by Balke in 1963, is one of the tests widely used to assess functional exercise capacity evaluated by measuring the distance walked during 6 min. The test is easy to administer and is better tolerated and more reflective of the activities of daily living than other walk tests. Most activities of daily life usually are performed at a submaximal level of exertion, so the 6MWT seems to better reflect the functional exercise level for daily physical activities. Accordingly, the 6MWT would be a good estimation tool for objective health and assessment in pneumoconiosis and the test will be carried out according to the standards of the American Thoracic Society . The 6MWT will be conducted by trained investigators or research assistants.
次要结局
- Change of St. George's Respiratory Questionnaire - Hong Kong version (SGRQ-HK) at weeks 4, 8, 12, 16 and 20(Baseline, weeks 4, 8, 12, 16 and 20)
- Change of Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8, 12, 16 and 20(Baseline, weeks 4, 8, 12, 16 and 20)
- Change of Hospital anxiety and depression scale (HADS) at weeks 4, 8, 12, 16 and 20(Baseline, weeks 4, 8, 12, 16 and 20)
- Change of COPD Assessment Test (CAT) at weeks 4, 8, 12, 16 and 20(Baseline, weeks 4, 8, 12, 16 and 20)
- Change of Patient Global Impression of Change (PGIC) at weeks 4, 8, 12, 16, 20(Baseline, weeks 4, 8, 12, 16, 20)
- Frequency of patients suffering from colds after baseline(From baseline to week 20)
- Incidence of patient hospitalization during the trial(From baseline to week 20)
- Change of the measurement of the body weight of patients(From baseline to week 20)
- Adverse events related to study treatment(From baseline to week 20)
研究者
XIAN Yanfang
Prof. XIAN Yanfang, Assistant professor, School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong
Chinese University of Hong Kong