NL-OMON35218尚未招募不适用
A double blind, randomized placebo-controlled cross-over study on the cardiovascular effects of Salvia miltiorrhiza extract (Danshen) in patients with hypertension and hyperlipidemia - Cardiovascular effects of Salvia miltiorrhiza extract (Danshen)
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age: 40-70 (50% men / 50% women)
- •- postmenopausal, or
- •- use of contraceptive pill
- •* Hyperlipidemia
- •- elevated level of triglycerides: > 1.7 mmol/L
- •- elevated level of LDL-cholesterol: > 3.5 mmol/L
- •- reduced level of HDL-cholesterol: < 1.03 mmol/L
- •* Hypertension:
- •- systolic pressure > 90 mm Hg
- •- diastolic pressure > 140 mm Hg
- •* Signed informed consent
排除标准
- •* Alcohol or drug abuse
- •* History of cardiovascular disease (myocard infarct, angina pectoris, CVA, CI)
- •* Diabetes mellitus
- •* Pregnancy
- •* Concomitant (chronic) use of:
- •- ACE-inhibitors
- •- Anticoagulant drugs
- •- > 1 antihypertensive drug
- •- High-dose antihypertensive medication (above defined daily dose)
- •- (Antioxidant) vitamin supplements
- •* Clinically significant liver disease (3 times the upper normal limit of ALAT,ASAT,AF, *GT or LDH)
- •* Clinically significant anemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L)
- •* Abnormal creatinine clearance (adjusted for age of subject)
- •* Participation to any drug-investigation during the previous 90 days
研究者
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