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

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ginsengberry concentrate

• Registration Number: NCT05725044
• Lead Sponsor: Amorepacific Corporation

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.

Study Timeline

• Study Start: 2021-12-13
• Status Verified: 2023-01
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Primary Completion: 2023-03-03
• Study Completion: 2023-05-03
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This group takes placebo for 8 weeks.
Ginsengberry concentrate	Ginsengberry concentrate	This group takes Ginsengberry concentrate for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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.)
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.)
Blood Indicators Related to Mental Fatigue	8 weeks	Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Blood Indicators Related to Physical Fatigue	8 weeks	lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
exercise test	8 weeks	VO2max (ml/kg/min, maximal oxygen consumption)

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of