DyslipidemiasNCT01563770
Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)
A study testing Salvia miltiorrhiza extract in people with Dyslipidemias and Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Dyslipidemias, Hypertension, Vasodilation
- What is being tested?
- Salvia miltiorrhiza extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-70
- Women:
- postmenopausal, or
- use of contraceptive pill
- Hyperlipidemia:
- elevated level of triglycerides: > 1.7 mmol/L, or
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- elevated level of LDL-cholesterol: > 3.5 mmol/L
- Hypertension:
- systolic pressure > 140 mm Hg, or
- diastolic pressure > 90 mm Hg
- Signed informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
Pauline Breedveld, PhD, +31-243614597, p.breedveld@pharmtox.umcn.nl
Pleun van Poppel, MD, +31-243667211, p.vanpoppel@aig.umcn.nl
About this study
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.
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
- Being tested
- Salvia miltiorrhiza extract, Placebo
- 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
- Medical subject headings
- Dyslipidemias, Hypertension, Aneurysm, Inflammation, Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvia miltiorrhiza extractDietary supplement
Also called Danshen
3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks
PlaceboDietary supplement
3 placebo capsules, twice daily for four consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Salvia miltiorrhiza extract (Danshen) | Experimental | p.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks Receives: Dietary Supplement: Salvia miltiorrhiza extract |
| placebo | Placebo comparator | p.o. placebo, twice daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperlipidemia
Blood tests: lipids, in particular LDL-cholesterol.
Measured: after 4 weeks of treatment with Danshen
Secondary outcomes (6)
Hypertension
Measured: after 4 weeks of treatment with Danshen
Endothelial function
Measured: after 4 weeks of treatment with Danshen
Plasma markers of oxidative stress
Measured: after 4 weeks of treatment with Danshen
Vascular inflammation and inflammatory activation of adipose tissue
Measured: after 4 weeks of treatment with danshen
Hemostasis and hemorheological parameters
Measured: after 4 weeks of treatment with Danshen
Insulin sensitivity
Measured: after 4 weeks of treatment with Danshen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Rongen, MD, PhD, Professor, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563770
- Sponsor's protocol ID
- QPHT-35
- Status last verified
- Jan 2012
- First submitted
- 23 Mar 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26192328
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01563770
- Acronym / sponsor ID
- QPHT-35
- Conditions
- Dyslipidemias, Hypertension, Vasodilation, Oxidative Stress, Inflammation
- Keywords
- Hyperlipidemia, Hypertension, Vasodilation, Oxidative stress, Inflammation, Hemostasis, Hemorheology, Cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvia miltiorrhiza extract (Danshen) | Experimental | Dietary Supplement: Salvia miltiorrhiza extractp.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks |
| placebo | Placebo comparator | Dietary Supplement: Placebop.o. placebo, twice daily |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 40-70
- Women:
- Hyperlipidemia:
- Hypertension:
- Signed informed consent
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvia miltiorrhiza extractAlso: Danshen3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks | Dietary supplement | Salvia miltiorrhiza extract (Danshen) |
| Placebo3 placebo capsules, twice daily for four consecutive weeks | Dietary supplement | placebo |
Primary outcome
Hyperlipidemia
Time frame: after 4 weeks of treatment with Danshen
Blood tests: lipids, in particular LDL-cholesterol.
6 secondary outcomes
Hypertension
Time frame: after 4 weeks of treatment with Danshen
Endothelial function
Time frame: after 4 weeks of treatment with Danshen
Plasma markers of oxidative stress
Time frame: after 4 weeks of treatment with Danshen
Vascular inflammation and inflammatory activation of adipose tissue
Time frame: after 4 weeks of treatment with danshen
Hemostasis and hemorheological parameters
Time frame: after 4 weeks of treatment with Danshen
Insulin sensitivity
Time frame: after 4 weeks of treatment with Danshen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
- Derived from this study: PubMed 26192328van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Rongen, MD, PhD, Professor principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvia miltiorrhiza extract in people with Dyslipidemias and Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline Breedveld, PhD (+31243614597, p.breedveld@pharmtox.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperlipidemia (time frame: after 4 weeks of treatment with Danshen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2012; AzTrials last refreshed its copy on 8 Nov 2026.