The clinical effects of Daeshiho-tang on hyperlipidemia patients

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0006132
• Lead Sponsor: Kyung Hee University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-08
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. eligible subject with 19-70 years old
2. Total cholesterol: over 200 mg/dL, TG: 150-500 mg/dL, LDL-cholesterol: 130-250 mg/dL, HDL-cholesterol: below 40 mg/d

Exclusion Criteria

1. Subjects who had a history of hypersensitivity or allergies to the components of study medication
2. Subjects who have unstable angina or myocardial infarction; a history of coronary artery bypass graft or percutaneous coronary intervention within 12 weeks before screening; transient ischemic attack or cerebrovascular disease; any malignant tumor within five years before screening.
3. Subjects with unstable hypertension (SBP = 180mmHg or DBP = 110mmHg), Diabetes (HbA1c = 9%), AST or ALT = 3 x UNL / Creatinine clearance <30mL/min or Creatinine = 2 x UNL / Creatine kinase (CK) >2 UNL / Rhabdomyolysis or thyroidal disease, pancreatitis
4. Subjects who has administered a contraindication drug during the clinical trial period or is judged to be inevitable to administer a contraindication drug.
5. Subjects who receive antilipemic agents within 1 month prior to the pre-screening period.
6. Subjects who have participated in other clinical trials within the last 3 months
7. Subjects who are planning to perform a diet program during the period of participation in this clinical trial for the purpose of treating hyperlipidemia, or who are planning to discontinue diet if they are already performing a diet program.
8. Female subjects who are pregnant, lactating, or who plan to conceive.
9. Female subjects who plan to conceive.
10. Subjects who are considered by the investigator to be inappropriate to participate in this trial.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of TG from the baseline after 8-week treatment

Secondary Outcome Measures

Name	Time	Method
Changes of TG, TC, LDL-C, HDL-C, Apo A-I, Apo B from the baseline after 8-week treatment;