Discipline of Chinese Medicine, School of Health Sciences and Health Innovations Research Institute (HIRi), RMIT University, Bundoora, VIC, Australia.
Trials. 2011 Jun 30;12:164. doi: 10.1186/1745-6215-12-164.
Chronic obstructive pulmonary disease (COPD) impairs quality of life and leads to premature mortality. COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities. Ginseng has been used for thousands of years in Chinese medicine for respiratory symptoms. Several controlled clinical trials using ginseng for COPD have shown promising clinical effect, however these studies were generally small and with some potential bias, prompting the need for rigorously designed studies.
The objective of this study is to evaluate the therapeutic value and safety profile of a standardised root extract of Panax ginseng C.A Meyer (ginseng) for symptomatic relief, with a focus on quality of life (QoL) improvements in individuals with moderate (Stage II) COPD FEV1/FVC < 0.7 and FEV₁ 50%-80% predicted.
This paper describes the design of a randomised, multi-centre, double-blind, placebo controlled, two-armed parallel clinical trial. Two trial sites in Melbourne Australia will proportionately randomise a total of 168 participants to receive either ginseng capsule (100 mg) or matching placebo twice daily for 24 weeks. The primary outcomes will be based on three validated QoL questionnaires, St Georges Respiratory Questionnaire (SGRQ), Short Form Health Survey (SF-36) and the COPD Assessment Test (CAT). Secondary outcomes are based on lung function testing, relief medication usage and exacerbation frequency and severity. Safety endpoints include blood tests and adverse event reporting. Intention-to-treat will be applied to all data analyses.
Findings from this study may lead to new therapeutic development for chronic respiratory diseases, particularly COPD. This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000768099.
慢性阻塞性肺疾病（COPD）会降低生活质量并导致过早死亡。COPD 患者的肺部功能会逐渐恶化，日常活动能力也会下降。人参在中国医学中已经使用了数千年，用于治疗呼吸症状。几项使用人参治疗 COPD 的对照临床试验显示出了有前景的临床效果，但这些研究通常规模较小，存在一定的潜在偏倚，因此需要进行严格设计的研究。
本研究旨在评估标准化人参根提取物（Panax ginseng C.A Meyer，人参）对症状缓解的治疗价值和安全性，重点关注中重度（II 期）COPD 患者（FEV1/FVC < 0.7 且 FEV₁ 为 50%-80%预计值）的生活质量（QoL）改善。
本文描述了一项随机、多中心、双盲、安慰剂对照、双臂平行临床试验的设计。澳大利亚墨尔本的两个试验地点将按比例随机分配总共 168 名参与者，分别接受每日两次人参胶囊（100 毫克）或匹配安慰剂治疗 24 周。主要结局将基于三个经过验证的 QoL 问卷，即圣乔治呼吸问卷（SGRQ）、简短健康调查（SF-36）和 COPD 评估测试（CAT）。次要结局基于肺功能测试、缓解药物使用和加重频率和严重程度。安全性终点包括血液测试和不良事件报告。所有数据分析均采用意向治疗。
这项研究的结果可能为慢性呼吸系统疾病，特别是 COPD 的治疗开发带来新的方向。本方案也可能为未来其他研究人员开发高质量草药药物临床试验提供指导。
澳大利亚和新西兰临床试验注册（ANZCTR）：ACTRN12610000768099。
