NCT01563770Unknown不适用
A Double Blind, Randomized Placebo-controlled Cross-over Study on the Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen) in Patients With Hypertension and Hyperlipidemia.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hyperlipidemia
研究概览
简要总结
Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and myocardial infarction. Several preclinical studies point towards promising effects of Danshen on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and hypertension.
Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on hypertension. Further objectives are to determine its effect on endothelial function, oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40-70
- •postmenopausal, or
- •use of contraceptive pill
- •Hyperlipidemia:
- •elevated level of triglycerides: > 1.7 mmol/L, or
- •elevated level of LDL-cholesterol: > 3.5 mmol/L
- •Hypertension:
- •systolic pressure > 140 mm Hg, or
- •diastolic pressure > 90 mm Hg
- •Signed informed consent
排除标准
- •Alcohol or drug abuse
- •History of cardiovascular disease (myocard infarct, angina pectoris, CVA)
- •Diabetes mellitus, when treated with insulin
- •Pregnancy
- •Hyperlipidemia which needs conventional treatment
- •elevated level of triglycerides: > 8 mmol/L
- •elevated level of LDL-cholesterol: > 5 mmol/L
- •Hypertension which needs conventional treatment:
- •systolic pressure > 180 mm Hg
- •diastolic pressure > 110 mm Hg
- •Clinically significant liver disease (3 times the upper normal limit of ALAT,ASAT)
- •Clinically significant anemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L)
- •Renal disease defined as MDRD < 60 ml/min/1.73m2
- •Participation to any drug-investigation during the previous 90 days
- •Use of any herbal product during the previous 30 days
- •Concomitant (chronic) use of:
- •Medicinal products:
- •ACE-inhibitors, including a.o. captopril, enalapril, ramipril
- •AT1-antagonists, including a.o. losartan, valsartan, irbesartan
- •Statins, including a.o. simvastatin, rosuvastatin
- •Anticoagulant drugs, including a.o. aspirin
- •Calciumantagonists (including a.o. amlodipine, nifedipine, verapamil)
- •Use of more than 1 antihypertensive drug
- •High-dose antihypertensive medication (above defined daily dose)
- •Drugs which are exclusively metabolised by CYP3A4 (Flockhart DA; P450 drug interaction table, including a.o. erythromycin, midazolam, cyclosporine, HIV antivirals)
- •Food products:
- •(Antioxidant) vitamin supplements
- •Other herbs, including a.o. St John's wort
- •Grapefruit juice
结局指标
主要结局
Hyperlipidemia
时间窗: after 4 weeks of treatment with Danshen
Blood tests: lipids, in particular LDL-cholesterol.
次要结局
- Hypertension(after 4 weeks of treatment with Danshen)
- Endothelial function(after 4 weeks of treatment with Danshen)
- Plasma markers of oxidative stress(after 4 weeks of treatment with Danshen)
- Vascular inflammation and inflammatory activation of adipose tissue(after 4 weeks of treatment with danshen)
- Hemostasis and hemorheological parameters(after 4 weeks of treatment with Danshen)
- Insulin sensitivity(after 4 weeks of treatment with Danshen)
研究者
研究点 (2)
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