NCT03775837

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

7.1 years

First QC Date

December 11, 2018

Last Update Submit

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

EXPERIMENTAL

This group takes Panax Ginseng C.A. Mey Extract for 8 weeks

Dietary Supplement: Panax Ginseng C.A. Mey Extract group

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 8 weeks

Dietary Supplement: Placebo group

Interventions

This group takes Panax Ginseng C.A. Mey Extract for 8 weeks

Panax Ginseng C.A. Mey Extract group
Placebo groupDIETARY_SUPPLEMENT

This group takes placebo for 8 weeks

Placebo group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Sang Yeoup Lee

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Yeoup Lee

CONTACT

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

Locations