Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

NCT01563770 | Unknown DMC

• 1 other identifier: QPHT-35
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Hyperlipidemia

  Blood tests: lipids, in particular LDL-cholesterol.

  after 4 weeks of treatment with Danshen

Secondary Outcomes (6)

• Hypertension

  after 4 weeks of treatment with Danshen

• Endothelial function

  after 4 weeks of treatment with Danshen

• Plasma markers of oxidative stress

  after 4 weeks of treatment with Danshen

• Vascular inflammation and inflammatory activation of adipose tissue

  after 4 weeks of treatment with danshen

• Hemostasis and hemorheological parameters

  after 4 weeks of treatment with Danshen

Study Arms (2)

Salvia miltiorrhiza extract (Danshen)

EXPERIMENTAL

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

Dietary Supplement: Salvia miltiorrhiza extract

placebo

PLACEBO COMPARATOR

p.o. placebo, twice daily

Dietary Supplement: Placebo

Interventions

Salvia miltiorrhiza extract DIETARY_SUPPLEMENT

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

Also known as: Danshen

Salvia miltiorrhiza extract (Danshen)

Placebo DIETARY_SUPPLEMENT

3 placebo capsules, twice daily for four consecutive weeks

placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 26192328 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Hypertension; Aneurysm; Inflammation; Hyperlipidemias; Cardiovascular Diseases

Interventions

dan-shen root extract

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Rongen, MD, PhD, Professor

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Breedveld, PhD

CONTACT

+31243614597; p.breedveld@pharmtox.umcn.nl

Pleun van Poppel, MD

CONTACT

+31243667211; p.vanpoppel@aig.umcn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 24, 2012

Record last verified: 2012-01

Locations

NL (1)