The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- miRNAs spectrum
研究概览
简要总结
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
详细描述
The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
- •Postoperative routine drug treatment
- •Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- •Aged 35 to 75 years old
- •Must sign a consent form.
排除标准
- •Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- •With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- •Serious cardiac insufficiency (EF < 35%)
- •Uncontrolled patients with high blood pressure
- •Merger or severe valvular heart disease in acute cerebrovascular disease
- •Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
- •Patients with severe mental illness
- •Patients with malignant tumor or life expectancy in less than three years
- •Patients with severe hematopoietic system disease
- •Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
- •Pregnancy or ready to pregnant women, nursing mothers;
- •Participated in nearly three months, or is in other clinical subjects . -
研究组 & 干预措施
Tongguan capsule
Tongguan capsule (0.5 g tid. for 6 months)
干预措施: Tongguan capsule (Drug)
placebo capsule
same volume/day of placebo capsule (0.5 g tid. for 6 months)
干预措施: placebo capsule (Drug)
结局指标
主要结局
miRNAs spectrum
时间窗: six months
Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
次要结局
- Serum E(6 months)
- Inflammatory mediators(6 months)
- Echocardiography measure of left ventricular systolic function(6 months)
- New York Heart Association functional classification(6 months)
- major adverse cardiac event(six months)
- Ang II predicts cardiovascular homeostasis and ventricular remodeling(6 months)
- Brain Natriuretic Peptide(6 months)
- Echocardiography measure of left ventricular diastolic function(6 months)
- Coronary angiography(6 months)
- Renin predicts cardiovascular homeostasis and ventricular remodeling(6 months)
- Seattle Angina Questionnaire score(6 months)
- The traditional Chinese medicine syndrome scale(6 months)
研究者
Huizheng Zhu
physician
Guangdong Provincial Hospital of Traditional Chinese Medicine