Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Not Applicable

• Conditions: Dyslipidemias; Hypertension; Vasodilation; Oxidative Stress; Inflammation
• Interventions: Dietary Supplement: Salvia miltiorrhiza extract; Dietary Supplement: Placebo

• Registration Number: NCT01563770
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-24
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salvia miltiorrhiza extract (Danshen)	Salvia miltiorrhiza extract	p.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks
placebo	Placebo	p.o. placebo, twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands