Clincosm LogoSign in Get a demo

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

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03775837
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
20
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Panax Ginseng C.A. Mey Extract group
  • Dietary Supplement: Placebo group
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Alanine aminotransferase [8 weeks]

    Alanine aminotransferase

Secondary Outcome Measures

  1. Aspartate aminotransferase [8 weeks]

    Aspartate aminotransferase

  2. Gamma-glutamyl transferase [8 weeks]

    Gamma-glutamyl transferase

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrated Research Institute for Natural Ingredients and Functional Foods Yangsan Korea, Republic of 50612

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT03775837
Other Study ID Numbers:
  • 02-2018-031
First Posted:
Dec 14, 2018
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases

Study Results

No Results Posted as of Sep 16, 2020