DyslipidemiasPhase 4NCT01697735
The Therapeutic Effects of Statins and Berberine on the Hyperlipemia
A Phase 4 study testing Berberine;Atorvastatin or Rosuvastatin and Atorvastatin or Rosuvastatin in people with Dyslipidemias, run by Wenzhou Medical University at 1 site in China.
Trial summary
Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Berberine;Atorvastatin or Rosuvastatin and Atorvastatin or Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2015
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current use of lipid-lowering medications;
- Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);
- Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease [glomerular filtration rate (GFR) < 60 mL/min/1.73㎡];
- Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
- A calculated SCORE ≥1% for 10 year risk of fatal CVD
Who cannot join
- Cancer;
- HIV infected;
- Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
- Active liver disease or unexplained persistent elevated transaminase levels；
- Major surgery or hospitalization in the 3 months prior to study entry;
- Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
Show all 11Show fewer
- Female of childbearing potential;
- Severe gastrointestinal disease;
- With berberine using contraindications;
- Secondary hyperlipidemia
- Current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
About this study
Official title: The Therapeutic Effects of Combination of Statins With Berberine on the Patients With Hyperlipemia:a Single-center, Open Clinical Trial
Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. If investigators are simply doubling the statins, that only 6% of the benefit can be received. And it often has significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
Read the detailed description
Patients at risk for cardiovascular disease (CVD) are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these patients have a lower incidence of coronary artery disease, ischemic stroke, and peripheral arterial disease and so on. But there are many patients whose hyperlipemia are not well controlled.If investigators are simply doubling the statins, that only 6% of the benefit can be received.And it often bring significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lowering blood lipids.The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
This study will enroll patients who currently take cholesterol-lowering medications，but the level of lipid is not controlled well. Patients will be assigned to receive 500mg of Berberine twice a day(meanwhile they are taking 20mg of Atorvastatin daily for 8 weeks or 10mg of Rosuvastatin daily for 8 weeks). Investigators will occur at baseline and Weeks 4 and 8. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue at baseline and weeks 4 and 8. Pill count will be used to assess adherence of Berberine and statins treatment at weeks 4 and 8. At weeks 4 and 8, medication side effects will be monitored and tests of alanine aminotransferase (ALT) and creatine phosphate kinase (CPK) will be performed. At weeks 4 and 8, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.
- Conditions
- Dyslipidemias
- Being tested
- Berberine;Atorvastatin or Rosuvastatin, Atorvastatin or Rosuvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine;Atorvastatin or RosuvastatinDrug
Also called Berberine;, Liptor, Crestor
Participants will receive 500mg Berberine twice a day for 8 weeks; Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily.
Atorvastatin or RosuvastatinDrug
Also called Liptor, Crestor
Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.
| Study group | Role | What they receive |
|---|---|---|
| Berberine;Atorvastatin or Rosuvastatin | Experimental | Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily; Besides taking statins, Participants will receive 500mg berberine twice a day for 8 weeks. Receives: Drug: Berberine;Atorvastatin or Rosuvastatin |
| Atorvastatin or Rosuvastatin | Active comparator | Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia. Receives: Drug: Atorvastatin or Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in combination statins with berberine on lipid level
Measured: Measured at baseline, weeks 4 and 8
Secondary outcomes (1)
Adherence of statins and berberine treatment
Measured: Measured at weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Because of lack of participants and funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- 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 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kangting Ji, MD, Wenzhou Medical University
- Investigators
- Jifei Tang, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697735
- Sponsor's protocol ID
- WZ medical college
- Status last verified
- Apr 2016
- First submitted
- 28 Sep 2012
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of Combination of Statins With Berberine on the Patients With Hyperlipemia:a Single-center, Open Clinical Trial
- ClinicalTrials.gov ID
- NCT01697735
- Acronym / sponsor ID
- WZ medical college
- Conditions
- Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of lack of participants and funds
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Oct 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.
Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. If investigators are simply doubling the statins, that only 6% of the benefit can be received. And it often has significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
Detailed description
Patients at risk for cardiovascular disease (CVD) are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these patients have a lower incidence of coronary artery disease, ischemic stroke, and peripheral arterial disease and so on. But there are many patients whose hyperlipemia are not well controlled.If investigators are simply doubling the statins, that only 6% of the benefit can be received.And it often bring significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lowering blood lipids.The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
This study will enroll patients who currently take cholesterol-lowering medications，but the level of lipid is not controlled well. Patients will be assigned to receive 500mg of Berberine twice a day(meanwhile they are taking 20mg of Atorvastatin daily for 8 weeks or 10mg of Rosuvastatin daily for 8 weeks). Investigators will occur at baseline and Weeks 4 and 8. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue at baseline and weeks 4 and 8. Pill count will be used to assess adherence of Berberine and statins treatment at weeks 4 and 8. At weeks 4 and 8, medication side effects will be monitored and tests of alanine aminotransferase (ALT) and creatine phosphate kinase (CPK) will be performed. At weeks 4 and 8, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine;Atorvastatin or Rosuvastatin | Experimental | Drug: Berberine;Atorvastatin or RosuvastatinFollow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily; Besides taking statins, Participants will receive 500mg berberine twice a day for 8 weeks. |
| Atorvastatin or Rosuvastatin | Active comparator | Drug: Atorvastatin or RosuvastatinDue to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current use of lipid-lowering medications;
- Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);
- Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease [glomerular filtration rate (GFR) < 60 mL/min/1.73㎡];
- Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
- A calculated SCORE ≥1% for 10 year risk of fatal CVD
Key exclusion criteria (11 listed)
- Cancer;
- HIV infected;
- Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
- Active liver disease or unexplained persistent elevated transaminase levels；
- Major surgery or hospitalization in the 3 months prior to study entry;
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 |
|---|---|---|
| Berberine;Atorvastatin or RosuvastatinAlso: Berberine;, Liptor, CrestorParticipants will receive 500mg Berberine twice a day for 8 weeks; Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily. | Drug | Berberine;Atorvastatin or Rosuvastatin |
| Atorvastatin or RosuvastatinAlso: Liptor, CrestorDue to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia. | Drug | Atorvastatin or Rosuvastatin |
Primary outcome
Change from baseline in combination statins with berberine on lipid level
Time frame: Measured at baseline, weeks 4 and 8
1 secondary outcome
Adherence of statins and berberine treatment
Time frame: Measured at weeks 4 and 8
Results and safety
The study was stopped early (reason given: Because of lack of participants and funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Related trials for Dyslipidemias
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Jifei Tang, MD principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Berberine;Atorvastatin or Rosuvastatin and Atorvastatin or Rosuvastatin in people with Dyslipidemias, run by Wenzhou Medical University at 1 site in China.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Apr 2016. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Because of lack of participants and funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in combination statins with berberine on lipid level (time frame: Measured at baseline, weeks 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2016.