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

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

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

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ginsengberry concentrate

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Collaborators: Inha University Hospital
• Investigators: Study Director: Kyung Lim Joa, Dr, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: AP-PV-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No