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Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Primary Purpose

Dyslipidemias, Hypertension, Vasodilation

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Salvia miltiorrhiza extract

Placebo

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring 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

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Radboud University Nijmegen Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salvia miltiorrhiza extract (Danshen)

placebo

Arm Description

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

p.o. placebo, twice daily

Outcomes

Primary Outcome Measures

Hyperlipidemia

Blood tests: lipids, in particular LDL-cholesterol.

Secondary Outcome Measures

Hypertension

Endothelial function

Plasma markers of oxidative stress

Vascular inflammation and inflammatory activation of adipose tissue

Hemostasis and hemorheological parameters

Insulin sensitivity

Full Information

NCT ID

NCT01563770

First Posted

March 23, 2012

Last Updated

May 23, 2012

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01563770

Brief Title

Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

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 Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias, Hypertension, Vasodilation, Oxidative Stress, Inflammation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Salvia miltiorrhiza extract (Danshen)

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

p.o. placebo, twice daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Salvia miltiorrhiza extract

Other Intervention Name(s)

Danshen

Intervention Description

3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

3 placebo capsules, twice daily for four consecutive weeks

Primary Outcome Measure Information:

Title

Hyperlipidemia

Description

Blood tests: lipids, in particular LDL-cholesterol.

Time Frame

after 4 weeks of treatment with Danshen

Secondary Outcome Measure Information:

Title

Hypertension

Time Frame

after 4 weeks of treatment with Danshen

Title

Endothelial function

Time Frame

after 4 weeks of treatment with Danshen

Title

Plasma markers of oxidative stress

Time Frame

after 4 weeks of treatment with Danshen

Title

Vascular inflammation and inflammatory activation of adipose tissue

Time Frame

after 4 weeks of treatment with danshen

Title

Hemostasis and hemorheological parameters

Time Frame

after 4 weeks of treatment with Danshen

Title

Insulin sensitivity

Time Frame

after 4 weeks of treatment with Danshen

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pauline Breedveld, PhD

Phone

+31243614597

p.breedveld@pharmtox.umcn.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Pleun van Poppel, MD

Phone

+31243667211

p.vanpoppel@aig.umcn.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard Rongen, MD, PhD, Professor

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pauline Breedveld, PhD

Phone

+31-243614597

p.breedveld@pharmtox.umcn.nl

First Name & Middle Initial & Last Name & Degree

Pleun van Poppel, MD

Phone

+31-243667211

p.vanpoppel@aig.umcn.nl

First Name & Middle Initial & Last Name & Degree

Gerard Rongen, MD, PhD, Professor

First Name & Middle Initial & Last Name & Degree

Cees J. Tack, MD, PhD, Prof

12. IPD Sharing Statement

Citations:

PubMed Identifier

26192328

Citation

van Poppel PC, Breedveld P, Abbink EJ, Roelofs H, van Heerde W, Smits P, Lin W, Tan AH, Russel FG, Donders R, Tack CJ, Rongen GA. Salvia Miltiorrhiza Root Water-Extract (Danshen) Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial. PLoS One. 2015 Jul 20;10(7):e0128695. doi: 10.1371/journal.pone.0128695. eCollection 2015.

Results Reference

derived

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Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

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