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Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

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ClinicalTrials.gov Identifier: NCT01563770
Recruitment Status : Unknown
Verified January 2012 by Radboud University.
Recruitment status was:  Recruiting
First Posted : March 27, 2012
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
Radboud University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Salvia

Arms and Interventions
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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 Name: Danshen
Placebo Comparator: placebo
p.o. placebo, twice daily
 Dietary Supplement: Placebo
3 placebo capsules, twice daily for four consecutive weeks


Outcome Measures
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Primary Outcome Measures :
  1. Hyperlipidemia [ Time Frame: after 4 weeks of treatment with Danshen ]
    Blood tests: lipids, in particular LDL-cholesterol.


Secondary Outcome Measures :
  1. Hypertension [ Time Frame: after 4 weeks of treatment with Danshen ]
  2. Endothelial function [ Time Frame: after 4 weeks of treatment with Danshen ]
  3. Plasma markers of oxidative stress [ Time Frame: after 4 weeks of treatment with Danshen ]
  4. Vascular inflammation and inflammatory activation of adipose tissue [ Time Frame: after 4 weeks of treatment with danshen ]
  5. Hemostasis and hemorheological parameters [ Time Frame: after 4 weeks of treatment with Danshen ]
  6. Insulin sensitivity [ Time Frame: after 4 weeks of treatment with Danshen ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563770


Contacts
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Contact: Pauline Breedveld, PhD +31243614597 p.breedveld@pharmtox.umcn.nl
Contact: Pleun van Poppel, MD +31243667211 p.vanpoppel@aig.umcn.nl

Locations
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Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Pauline Breedveld, PhD    +31-243614597    p.breedveld@pharmtox.umcn.nl   
Contact: Pleun van Poppel, MD    +31-243667211    p.vanpoppel@aig.umcn.nl   
Principal Investigator: Gerard Rongen, MD, PhD, Professor         
Sub-Investigator: Cees J. Tack, MD, PhD, Prof         
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Gerard Rongen, MD, PhD, Professor Radboud University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01563770    
Other Study ID Numbers: QPHT-35
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: January 2012
Keywords provided by Radboud University:
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
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Inflammation
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases