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

Sponsor

Amorepacific Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05725044

Collaborator

Inha University Hospital (Other)

Enrollment

Location

Arms

23.7

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Dietary Supplement: Ginsengberry concentrate Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.

Actual Study Start Date :

Dec 13, 2021

Anticipated Primary Completion Date :

Mar 3, 2023

Anticipated Study Completion Date :

Dec 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ginsengberry concentrate This group takes Ginsengberry concentrate for 8 weeks.	Dietary Supplement: Ginsengberry concentrate Ginsengberry concentrate
Placebo Comparator: Placebo This group takes placebo for 8 weeks.	Dietary Supplement: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Ginsengberry concentrate

This group takes Ginsengberry concentrate for 8 weeks.

Dietary Supplement: Ginsengberry concentrate

Ginsengberry concentrate

Placebo Comparator: Placebo

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

CIS [8 weeks]
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 [8 weeks]
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 [8 weeks]
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
Blood Indicators Related to Physical Fatigue [8 weeks]
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Blood Indicators Related to Mental Fatigue [8 weeks]
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
exercise test [8 weeks]
VO2max (ml/kg/min, maximal oxygen consumption)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inha University Hospital	Incheon		Korea, Republic of

Sponsors and Collaborators

Amorepacific Corporation
Inha University Hospital

Investigators

Study Director: Kyung Lim Joa, Dr, Inha University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amorepacific Corporation

ClinicalTrials.gov Identifier:

NCT05725044

Other Study ID Numbers:

AP-PV-2021-01

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Feb 13, 2023