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The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00316641
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients

Condition or Disease Intervention/Treatment Phase
  • Drug: Lipid-lowing Tea
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China Medical University Hospital Taichung Taiwan 404

    Sponsors and Collaborators

    • China Medical University Hospital

    Investigators

    • Principal Investigator: Chia-I Tsai, V.S, China Medical University Hospital,Taichung,Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00316641
    Other Study ID Numbers:
    • DMR93-IRB-71
    First Posted:
    Apr 21, 2006
    Last Update Posted:
    Nov 7, 2006
    Last Verified:
    Mar 1, 2006
    Additional relevant MeSH terms:
    Hyperlipidemias
    Hyperlipoproteinemias

    Study Results

    No Results Posted as of Nov 7, 2006