- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00316641
The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles
November 6, 2006 updated by: China Medical University Hospital
The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
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Contact:
- Chia-I Tsai, MD
- Phone Number: 5065 886-4-22052121
- Email: josepho777@yahoo.com.tw
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Principal Investigator:
- Chia-I Tsai, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chia-I Tsai, V.S, China Medical University Hospital,Taichung,Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 20, 2006
First Submitted That Met QC Criteria
April 20, 2006
First Posted (Estimate)
April 21, 2006
Study Record Updates
Last Update Posted (Estimate)
November 7, 2006
Last Update Submitted That Met QC Criteria
November 6, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR93-IRB-71
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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