Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Radboud University Medical Center

Status: Unknown

Conditions: Hypertension; Inflammation; Dyslipidemias; Vasodilation; Oxidative Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Salvia miltiorrhiza extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01563770

QPHT-35

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

Salvia miltiorrhiza extract (Danshen)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Salvia miltiorrhiza extract

placebo

Placebo Comparator group

Description:

p.o. placebo, twice daily

Treatment:

Dietary Supplement: Placebo