Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01563770
• Other study ID #: QPHT-35
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2012
• Last updated: May 23, 2012
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2012
• Source: Radboud University
• Contact: Pauline Breedveld, PhD
• Phone: +31243614597
• Email: p.breedveld[@]pharmtox.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: De Voedsel en Waren Autoriteit
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension
• Inflammation
• Oxidative Stress
• Vasodilation

Intervention

Dietary Supplement:
• Salvia miltiorrhiza extract
3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks
• Placebo
3 placebo capsules, twice daily for four consecutive weeks

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperlipidemia	Blood tests: lipids, in particular LDL-cholesterol.	after 4 weeks of treatment with Danshen	No
Secondary	Hypertension		after 4 weeks of treatment with Danshen	No
Secondary	Endothelial function		after 4 weeks of treatment with Danshen	No
Secondary	Plasma markers of oxidative stress		after 4 weeks of treatment with Danshen	No
Secondary	Vascular inflammation and inflammatory activation of adipose tissue		after 4 weeks of treatment with danshen	No
Secondary	Hemostasis and hemorheological parameters		after 4 weeks of treatment with Danshen	No
Secondary	Insulin sensitivity		after 4 weeks of treatment with Danshen	No