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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00316641
• Other study ID #: DMR93-IRB-71
• Status: Recruiting
• Phase: Phase 3
• First received: April 20, 2006
• Last updated: November 6, 2006

Study information

• Verified date: March 2006
• Source: China Medical University Hospital
• Contact: Chia-I Tsai, V.S
• Phone: 886-4-22052121
• Email: josepho777[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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, ß-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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Lipid-lowing Tea

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan,