NCT05725044

Brief Summary

The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

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

December 13, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

May 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 26, 2023

Last Update Submit

May 24, 2023

Conditions

Fatigue

Outcome Measures

Primary Outcomes (6)

  • CIS

    Checklist Individual Strength (20-item questionnaire, 1-7 Likert score, the minimum and maximum values is 20\~140. Higher scores mean a worse outcome.)

    8 weeks

  • FSS

    Fatigue severity Index (9-item questionnaire, 1-7 Likert scale, the minimum and maximum values is 9\~63. Higher scores mean a worse outcome.)

    8 weeks

  • NRS

    Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)

    8 weeks

  • Blood Indicators Related to Physical Fatigue

    lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)

    8 weeks

  • Blood Indicators Related to Mental Fatigue

    Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)

    8 weeks

  • exercise test

    VO2max (ml/kg/min, maximal oxygen consumption)

    8 weeks

Study Arms (2)

Ginsengberry concentrate

EXPERIMENTAL

This group takes Ginsengberry concentrate for 8 weeks.

Dietary Supplement: Ginsengberry concentrate

Placebo

PLACEBO COMPARATOR

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo

Interventions

Ginsengberry concentrateDIETARY_SUPPLEMENT

Ginsengberry concentrate

Ginsengberry concentrate
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age30 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- CIS \> 76 points

You may not qualify if:

  • A person who feels tired due to surgical operation within 6 months.
  • drug/alcoholic hepatitis, cirrhosis, and fatty liver
  • anorexia or bulimia
  • a person on night duty, shift work, or heavy redundancy
  • A person who is unable to perform an exercise load test
  • A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
  • A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
  • A person who continues to exercise regularly within three months of visiting
  • Immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung Lim Joa, Dr

    Inha University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 13, 2023

Study Start

December 13, 2021

Primary Completion

March 3, 2023

Study Completion

May 3, 2023

Last Updated

May 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)