Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)
This study is currently recruiting participants.
Verified January 2012 by Radboud University
Sponsor:
Radboud University
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
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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
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:
|
Hyperlipidemias Hypertension Inflammation Flushing Hyperemia Hot Flashes Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Signs and Symptoms Cardiovascular Agents Dan-shen root extract |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Hematologic Agents Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013