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Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01563770
First received: March 23, 2012
Last updated: May 23, 2012
Last verified: January 2012
  Purpose

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 Intervention
Dyslipidemias
Hypertension
Vasodilation
Oxidative Stress
Inflammation
Dietary Supplement: Salvia miltiorrhiza extract
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Hyperlipidemia [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]
    Blood tests: lipids, in particular LDL-cholesterol.


Secondary Outcome Measures:
  • Hypertension [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]
  • Plasma markers of oxidative stress [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]
  • Vascular inflammation and inflammatory activation of adipose tissue [ Time Frame: after 4 weeks of treatment with danshen ] [ Designated as safety issue: No ]
  • Hemostasis and hemorheological parameters [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: after 4 weeks of treatment with Danshen ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563770

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

Locations
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
Principal Investigator: Gerard Rongen, MD, PhD, Professor Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01563770     History of Changes
Other Study ID Numbers: QPHT-35
Study First Received: March 23, 2012
Last Updated: May 23, 2012
Health Authority: Netherlands: De Voedsel en Waren Autoriteit

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:
Dyslipidemias
Hypertension
Inflammation
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Dan-shen root extract
Molecular Mechanisms of Pharmacological Action
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014