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The clinical effects of Daeshiho-tang on hyperlipidemia patients

The clinical effects of Daeshiho-tang on hyperlipidemia patients: Randomized double blind pilot study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0006132
Enrollment
60
Registered
2021-05-12
Start date
2019-07-17
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Oral administration with Daeshiho-tang twice a day after every meal for 8 weeks

Sponsors

Kyung Hee University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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/dL

Exclusion criteria

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 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.

Design outcomes

Primary

MeasureTime frame
Changes of TG from the baseline after 8-week treatment

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactByung-Cheol Lee

Kyung Hee University Oriental Medical Center

hydrolee99@gmail.com@hydrolee99@gmail.com+82-2-958-9182

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026