Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Sponsor

Radboud University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01563770

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias Hypertension Vasodilation Oxidative Stress Inflammation	Dietary Supplement: Salvia miltiorrhiza extract Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double Blind, Randomized Placebo-controlled Cross-over Study on the Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen) in Patients With Hypertension and Hyperlipidemia.

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Salvia miltiorrhiza extract (Danshen) p.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks	Dietary Supplement: Salvia miltiorrhiza extract 3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks Other Names: Danshen
Placebo Comparator: placebo p.o. placebo, twice daily	Dietary Supplement: Placebo 3 placebo capsules, twice daily for four consecutive weeks

Arm

Intervention/Treatment

Experimental: Salvia miltiorrhiza extract (Danshen)

p.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks

Dietary Supplement: Salvia miltiorrhiza extract

3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks

Other Names:

Danshen

Placebo Comparator: placebo

p.o. placebo, twice daily

Dietary Supplement: Placebo

3 placebo capsules, twice daily for four consecutive weeks

Outcome Measures

Primary Outcome Measures

Hyperlipidemia [after 4 weeks of treatment with Danshen]
Blood tests: lipids, in particular LDL-cholesterol.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 40-70
Women:
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

Exclusion Criteria:

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)