Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults

Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults: a Randomized, Double-blinded, Placebo-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases
• Intervention / Treatment: Dietary supplement: Panax Ginseng C.A. Mey Extract group; Dietary supplement: Placebo group

Detailed Description

Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on liver function in adults; the safety of the compound are also evaluate. The Investigators examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey Extract or a placebo each day for 8 weeks;

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ye Li Lee; Phone Number: 055 360-2860; Email: yeri1230@gmail.com
• Study Contact Backup: Name: Sang Yeoup Lee; Phone Number: 055 360-2860; Email: saylee@pnu.edu

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 50612
    • Recruiting
    • Integrated Research Institute for Natural Ingredients and Functional Foods
    • Contact: Sang Yeoup Lee, MD; Phone Number: 82-55-360-2860; Email: saylee@pnu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ALT ranging from upper limit of reference to three times of upper limit

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panax Ginseng C.A. Mey Extract group; This group takes Panax Ginseng C.A. Mey Extract for 8 weeks	Dietary supplement: Panax Ginseng C.A. Mey Extract group; This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
Placebo Comparator: Placebo group; This group takes placebo for 8 weeks	Dietary supplement: Placebo group; This group takes placebo for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine aminotransferase	Alanine aminotransferase	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspartate aminotransferase	Aspartate aminotransferase	8 weeks
Gamma-glutamyl transferase	Gamma-glutamyl transferase	8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 02-2018-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No