fatigue: Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.
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 |
---|---|---|
|
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
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
|
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
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
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anorexia or bulimia
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a person on night duty, shift work, or heavy redundancy
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A person who is unable to perform an exercise load test
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A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
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A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
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A person who continues to exercise regularly within three months of visiting
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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.- AP-PV-2021-01