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

Primary Purpose

Liver Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Panax Ginseng C.A. Mey Extract group

Placebo group

About this trial

This is an interventional treatment trial for Liver Diseases

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Integrated Research Institute for Natural Ingredients and Functional FoodsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Panax Ginseng C.A. Mey Extract group

Placebo group

Arm Description

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

This group takes placebo for 8 weeks

Outcomes

Primary Outcome Measures

Alanine aminotransferase

Secondary Outcome Measures

Aspartate aminotransferase

Gamma-glutamyl transferase

Full Information

NCT ID

NCT03775837

First Posted

December 11, 2018

Last Updated

February 1, 2023

Sponsor

Pusan National University Yangsan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03775837

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Panax Ginseng C.A. Mey Extract group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

This group takes placebo for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Panax Ginseng C.A. Mey Extract group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo group

Intervention Description

This group takes placebo for 8 weeks

Primary Outcome Measure Information:

Title

Alanine aminotransferase

Description

Alanine aminotransferase

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Aspartate aminotransferase

Description

Aspartate aminotransferase

Time Frame

8 weeks

Title

Gamma-glutamyl transferase

Description

Gamma-glutamyl transferase

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang Yeoup Lee

Phone

360-2860

Ext

055

saylee@pnu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ye Li Lee

Phone

360-2860

Ext

055

yeri1230@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Yeoup Lee

Organizational Affiliation

Pusan National University Yangsan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integrated Research Institute for Natural Ingredients and Functional Foods

City

Yangsan

ZIP/Postal Code

50612

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang Yeoup Lee, MD

Phone

82-55-360-2860

saylee@pnu.edu

12. IPD Sharing Statement

Learn more about this trial

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

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