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

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ginsengberry concentrate
Placebo
Sponsored by
Amorepacific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

30 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Inha University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginsengberry concentrate

Placebo

Arm Description

This group takes Ginsengberry concentrate for 8 weeks.

This group takes placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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.)
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.)
NRS
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
Blood Indicators Related to Physical Fatigue
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Blood Indicators Related to Mental Fatigue
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
exercise test
VO2max (ml/kg/min, maximal oxygen consumption)

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
May 24, 2023
Sponsor
Amorepacific Corporation
Collaborators
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05725044
Brief Title
Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.
Acronym
fatigue
Official Title
Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amorepacific Corporation
Collaborators
Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginsengberry concentrate
Arm Type
Experimental
Arm Description
This group takes Ginsengberry concentrate for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginsengberry concentrate
Intervention Description
Ginsengberry concentrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
CIS
Description
Checklist Individual Strength (20-item questionnaire, 1-7 Likert score, the minimum and maximum values is 20~140. Higher scores mean a worse outcome.)
Time Frame
8 weeks
Title
FSS
Description
Fatigue severity Index (9-item questionnaire, 1-7 Likert scale, the minimum and maximum values is 9~63. Higher scores mean a worse outcome.)
Time Frame
8 weeks
Title
NRS
Description
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
Time Frame
8 weeks
Title
Blood Indicators Related to Physical Fatigue
Description
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Time Frame
8 weeks
Title
Blood Indicators Related to Mental Fatigue
Description
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Time Frame
8 weeks
Title
exercise test
Description
VO2max (ml/kg/min, maximal oxygen consumption)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Lim Joa, Dr
Organizational Affiliation
Inha University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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