Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.

NCT ID: NCT05725044

Last Updated: 2023-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2023-05-03

Brief Summary

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

Detailed Description

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Previous studies have indicated that ginseng root may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine FSS(fatigue severity scale), CIS, lactate, Ammonia, Exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ginsengberry concentrate

This group takes Ginsengberry concentrate for 8 weeks.

Group Type EXPERIMENTAL

Ginsengberry concentrate

Intervention Type DIETARY_SUPPLEMENT

Ginsengberry concentrate

Placebo

This group takes placebo for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Ginsengberry concentrate

Ginsengberry concentrate

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\- CIS \> 76 points

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inha University Hospital

OTHER

Sponsor Role collaborator

Amorepacific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung Lim Joa, Dr

Role: STUDY_DIRECTOR

Inha University Hospital

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AP-PV-2021-01

Identifier Type: -

Identifier Source: org_study_id

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