Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

NCT ID: NCT01563770

Last Updated: 2012-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-03-31

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.

Conditions

Dyslipidemias; Hypertension; Vasodilation; Oxidative Stress; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Salvia miltiorrhiza extract (Danshen)

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

Group Type: EXPERIMENTAL

Salvia miltiorrhiza extract

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

p.o. placebo, twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

3 placebo capsules, twice daily for four consecutive weeks

Interventions

Salvia miltiorrhiza extract

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

3 placebo capsules, twice daily for four consecutive weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Danshen

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Rongen, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Pauline Breedveld, PhD

Role: CONTACT

p.breedveld@pharmtox.umcn.nl

+31243614597

Pleun van Poppel, MD

Role: CONTACT

p.vanpoppel@aig.umcn.nl

+31243667211

Facility Contacts

Pauline Breedveld, PhD

Role: primary

p.breedveld@pharmtox.umcn.nl

+31-243614597

Pleun van Poppel, MD

Role: backup

p.vanpoppel@aig.umcn.nl

+31-243667211

References

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.

Reference Type: DERIVED

PMID: 26192328 (View on PubMed)

Other Identifiers

QPHT-35

Identifier Type: -

Identifier Source: org_study_id