Fatigue
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGinsengberry concentrate
Ginsengberry concentrate
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Inha University Hospital
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed