Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563770

Enrollment

Registered

2012-03-27

Start date

2012-04-30

Completion date

2013-03-31

Last updated

2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Hypertension, Inflammation, Oxidative Stress, Vasodilation

Keywords

Hyperlipidemia, Hypertension, Vasodilation, Oxidative stress, Inflammation, Hemostasis, Hemorheology, Cardiovascular diseases, Cardiovascular agents, Salvia miltiorrhiza, Danshen, Danshen root extract, Molecular Mechanisms of Pharmacological Action, Therapeutic Uses

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.

Interventions

DIETARY_SUPPLEMENTSalvia miltiorrhiza extract

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

DIETARY_SUPPLEMENTPlacebo

3 placebo capsules, twice daily for four consecutive weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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) Food products: * (Antioxidant) vitamin supplements * Other herbs, including a.o. St John's wort * Grapefruit juice

Design outcomes

Primary

Measure	Time frame	Description
Hyperlipidemia	after 4 weeks of treatment with Danshen	Blood tests: lipids, in particular LDL-cholesterol.

Secondary

Measure	Time frame
Endothelial function	after 4 weeks of treatment with Danshen
Plasma markers of oxidative stress	after 4 weeks of treatment with Danshen
Hypertension	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
Vascular inflammation and inflammatory activation of adipose tissue	after 4 weeks of treatment with danshen

Countries

Netherlands

Contacts

Primary ContactPauline Breedveld, PhD

p.breedveld@pharmtox.umcn.nl+31243614597

Backup ContactPleun van Poppel, MD

p.vanpoppel@aig.umcn.nl+31243667211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026