Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 10
- 主要终点
- TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed）
研究概览
简要总结
The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as examples to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).
- Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes of CHD and self-administrated scale of Stable Angina Pectoris
- research on all indicators of CHD, and analyze their characteristics, target and function
- theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and dissolving stasis as an example for clinical efficacy evaluation.
详细描述
Clinical efficacy is the basis of traditional Chinese medicine development, and scientific evaluation of TCM clinical efficacy and its effectiveness is the way to push TCM modernized and international. TCM theories of Overall concept and Differentiation for life science and diseases are hard to be generally accepted. Besides, no unified and standard methods fit to evaluate the TCM clinical efficacy. Thus, there is a need to do a deeper research of methodology, evaluative index, and evaluative criteria in order to guide the evaluation of TCM clinical efficacy.
Based on the situation above, the study aims to choose the best and characteristic evaluative index of clinical efficacy, compare the demand among practitioners, patients and care givers. After data collected, a new cluster of index among Biochemical, patients report outcomes, endpoint indicators, and TCM soft indicators could be constituted and analyzed to use in respective way according to their characteristics, target and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phlegm and blood stasis Syndrome G
干预措施: Louxiangdan Tongxin granules (Drug)
Phlegm and blood stasis Syndrome G
干预措施: Western basis treatment (Drug)
Phlegm and blood stasis control G
干预措施: TCM granules placebo (Drug)
Phlegm and blood stasis control G
干预措施: Western basis treatment (Drug)
Qi deficiency and blood stasis G
干预措施: Chixiangshen Tongxin granules (Drug)
Qi deficiency and blood stasis G
干预措施: Western basis treatment (Drug)
Qi deficiency and blood stasis control G
干预措施: TCM granule placebo plus western basis treatment (Drug)
Qi deficiency and blood stasis control G
干预措施: Western basis treatment (Drug)
结局指标
主要结局
TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed）
时间窗: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: patients report outcomes for SAP
时间窗: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: self-administrated scale of SAP
时间窗: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
次要结局
- Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification(Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week; and all except MYMOP taken one more at expected day 7 in screen)
- Biochemical index: ECG, ECG exercise test, blood lipids, blood glucose (fasting glucose), Blood, urine, liver function, renal function, coagulation, echocardiography (including heart function), coronary CT (some hospitals choose to do)(Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week)
- Quality of life evaluative index: Seattle angina questionnaire (SAQ)(Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week)
- Quality of life evaluative index: short form-12 (SF-12)(Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week)
- TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria)(Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week)
- Endpoint index （Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases）(Taken at 2nd, 4th, 8th, 12th, 26th week)
研究者
YANG Guan-lin
Principal of Liaoning university of TCM
Liaoning University of Traditional Chinese Medicine