Clinical trial NCT01563770: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hyperlipidemia
timeFrame: after 4 weeks of treatment with Danshen
Secondary outcomes:
measure: Hypertension
timeFrame: after 4 weeks of treatment with Danshen
measure: Endothelial function
timeFrame: after 4 weeks of treatment with Danshen
measure: Plasma markers of oxidative stress
timeFrame: after 4 weeks of treatment with Danshen
measure: Vascular inflammation and inflammatory activation of adipose tissue
timeFrame: after 4 weeks of treatment with danshen
measure: Hemostasis and hemorheological parameters
timeFrame: after 4 weeks of treatment with Danshen
measure: Insulin sensitivity
timeFrame: after 4 weeks of treatment with Danshen
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Gerard Rongen, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.