NCT02331589

Brief Summary

Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue. Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 31, 2014

Results QC Date

January 7, 2015

Last Update Submit

February 8, 2015

Conditions

Fatigue

Keywords

FatiguePanax ginsengChronic hepatitisNon-alcoholic Fatty Liver DiseaseAdiponectin

Outcome Measures

Primary Outcomes (1)

  • Liver Enzymes

    aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase

    3 weeks of KRG

Secondary Outcomes (3)

  • Fatigue as Measured by KRUPP's Fatigue Severity Scale

    3 weeks of KRG

  • Pro-inflammatory Cytokine

    3 weeks of KRG

  • Adiponectin

    3 weeks of KRG

Study Arms (2)

Korea Red Ginseng (KRG)

ACTIVE COMPARATOR

KRG capsule (3,000 mg/day) for 3 weeks

Drug: KRG (Korea Red ginseng)

Placebo (for KRG)

PLACEBO COMPARATOR

placebo (for KRG) for 3 weeks

Drug: Placebo (for KRG)

Interventions

KRG (Korea Red ginseng)DRUG

3 weeks of KRG capsule (3,000 mg/day)

Also known as: Korea Red ginseng capsule (3,000 mg/day)
Korea Red Ginseng (KRG)
Placebo (for KRG)DRUG

Placebos with same shape and size were manufactured and at Korea Ginseng Corporation

Also known as: Placebo
Placebo (for KRG)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

You may not qualify if:

  • viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueHepatitis, ChronicNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesFatty Liver

Results Point of Contact

Title
Dr. Ki Tae Suk
Organization
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
ktsuk@hallym.ac.kr
+82-33-240-5826

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor, assistant professor

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 6, 2015

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 10, 2015

Results First Posted

February 10, 2015

Record last verified: 2014-12