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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03775837
• Other study ID #: 02-2018-031
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Pusan National University Yangsan Hospital
• Contact: Sang Yeoup Lee
• Phone: 360-2860
• Email: saylee[@]pnu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Dietary Supplement:
• Panax Ginseng C.A. Mey Extract group
This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
• Placebo group
This group takes placebo for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Integrated Research Institute for Natural Ingredients and Functional Foods	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine aminotransferase	Alanine aminotransferase	8 weeks
Secondary	Aspartate aminotransferase	Aspartate aminotransferase	8 weeks
Secondary	Gamma-glutamyl transferase	Gamma-glutamyl transferase	8 weeks