HyperlipidemiaPhase 3NCT00316641
The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles
A Phase 3 study testing Lipid-lowing Tea in people with Hyperlipidemia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Lipid-lowing Tea
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patient aged 20-65 years;either sex
- Patient diagnosed with hyperlipidemia(fasting levels of TC>=200mg/dL),or TG>=200mg/dL but <400mg/dL,or LDL-C>=130mg/dL)
- Patient who has signed the informed consent form
Who cannot join
- Patient with pregnancy (or child bearing potential),or in lactation
- Patient with any lipid regulating agents within 4 weeks prior to study period
- Patient currently taking concomitant medications, such as oral contraceptives, or any medical treatment capable of interfering with lipid metabolism(eg thiazides, β-blockers, cyclosporins, itraconazole erythromycin,and danazol)
- Patient with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, primary biliary cirrhosis.
- Patient with liver dysfunction (SGOT or SGPT>2x ULN)
- Patient with renal insufficiency (serum creatinine>1.3mg/dL)
- Patient with myocardial infarction,cerebrovascular disease,or major operations within 6 months prior to the study period.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Chia-I Tsai, MD, 886-4-22052121 ext. 5065, josepho777@yahoo.com.tw
Chia-I Tsai, MD
About this study
The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients
- Conditions
- Hyperlipidemia
- Being tested
- Lipid-lowing Tea
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-lowing TeaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chia-I Tsai, V.S, Principal investigator, China Medical University Hospital,Taichung,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316641
- Sponsor's protocol ID
- DMR93-IRB-71
- Status last verified
- Mar 2006
- First submitted
- 20 Apr 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles
- ClinicalTrials.gov ID
- NCT00316641
- Acronym / sponsor ID
- DMR93-IRB-71
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- First posted
- 21 Apr 2006 (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.
The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 20-65 years;either sex
- Patient diagnosed with hyperlipidemia(fasting levels of TC>=200mg/dL),or TG>=200mg/dL but <400mg/dL,or LDL-C>=130mg/dL)
- Patient who has signed the informed consent form
Key exclusion criteria (7 listed)
- Patient with pregnancy (or child bearing potential),or in lactation
- Patient with any lipid regulating agents within 4 weeks prior to study period
- Patient currently taking concomitant medications, such as oral contraceptives, or any medical treatment capable of interfering with lipid metabolism(eg thiazides, β-blockers, cyclosporins, itraconazole erythromycin,and danazol)
- Patient with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, primary biliary cirrhosis.
- Patient with liver dysfunction (SGOT or SGPT>2x ULN)
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 |
|---|---|---|
| Lipid-lowing Tea | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
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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.
Chia-I Tsai, V.S principal investigator
China Medical University Hospital,Taichung,Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lipid-lowing Tea in people with Hyperlipidemia, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 7 Nov 2006. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chia-I Tsai, V.S (886-4-22052121 ext. 5065, josepho777@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Nov 2006.