A double blind, randomized placebo-controlled cross-over study on the cardiovascular effects of Salvia miltiorrhiza extract (Danshen) in patients with hypertension and hyperlipidemia

• Conditions: elevated levels of lipids in the blood; hyperlipidemia; 10013317; 10057166

• Registration Number: NL-OMON35218
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Age: 40-70 (50% men / 50% women)
* 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

Exclusion Criteria

* Smoking
* Alcohol or drug abuse
* History of cardiovascular disease (myocard infarct, angina pectoris, CVA, CI)
* Diabetes mellitus
* Pregnancy
* Concomitant (chronic) use of:
- ACE-inhibitors
- Statins
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome parameters will be assessed in the 4th week of each treatment period.<br /><br>To study the effect of Danshen on hyperlipidemia, in particular<br /><br>LDL-cholesterol, but also HDL-cholesterol, total cholesterol, total<br /><br>triglycerides, apolipoprotein B plasma levels and LDL oxidation will be<br /><br>measured.</p><br>