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

NCT ID: NCT03775837

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2025-12-31

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.

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;

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Panax Ginseng C.A. Mey Extract group

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

Group Type: EXPERIMENTAL

Panax Ginseng C.A. Mey Extract group

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

This group takes placebo for 8 weeks

Interventions

Panax Ginseng C.A. Mey Extract group

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

This group takes placebo for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Yeoup Lee

Role: CONTACT

saylee@pnu.edu

360-2860 ext. 055

Ye Li Lee

Role: CONTACT

yeri1230@gmail.com

360-2860 ext. 055

Facility Contacts

Sang Yeoup Lee, MD

Role: primary

saylee@pnu.edu

82-55-360-2860

Other Identifiers

02-2018-031

Identifier Type: -

Identifier Source: org_study_id