Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 4, 2025
June 1, 2025
7.1 years
December 11, 2018
June 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Alanine aminotransferase
Alanine aminotransferase
8 weeks
Secondary Outcomes (2)
Aspartate aminotransferase
8 weeks
Gamma-glutamyl transferase
8 weeks
Study Arms (2)
Panax Ginseng C.A. Mey Extract group
EXPERIMENTALThis group takes Panax Ginseng C.A. Mey Extract for 8 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 8 weeks
Interventions
This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
Eligibility Criteria
You may qualify if:
- ALT ranging from upper limit of reference to three times of upper limit
You may not qualify if:
- Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
- Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
- History of viral hepatitis or cancer
- Uncontrolled hypertension
- History of serious cardiac disease such as angina or myocardial infarction
- History of gastrectomy
- History of medication for psychiatric disease
- Administration of oriental medicine including herbs within the past 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, 50612, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee
Pusan National University Yangsan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 14, 2018
Study Start
December 1, 2018
Primary Completion
December 30, 2025
Study Completion
December 31, 2025
Last Updated
June 4, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share