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

Study Overview
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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.

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

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Ginsengberry concentrate
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginsengberry concentrate<br>This group takes Ginsengberry concentrate for 8 weeks. | Dietary Supplement: Ginsengberry concentrate<br>* Ginsengberry concentrate<br>|
| Placebo Comparator: Placebo<br>This group takes placebo for 8 weeks. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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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 |