None listed
Conditions
Interventions
Dietary Supplement : • ginseng berry extract group: 1 times a day, 2 capsules once, after breakfast, a duration of 12 weeks(1000 mg/day, ginseng berry extract for 600 mg/day)
• placebo group: 1 times
Sponsors
Korea Genetic Bio Pharm Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 19 years or older and 60 years or less at the screening examination 2) Participants with score of 27 or higher on the Fatigue Severity Scale (Fatigue severity scale) 3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions
Exclusion criteria
Exclusion criteria: (1) Subjects with a BMI of less than 18.5 kg/m² or 30 kg/m² or higher at the time of screening (2) Subjects with clinically significant acute or chronic cardiovascular, cerebrovascular, endocrine, immune, hepatobiliary, renal and urological, neuropsychiatric, inflammatory, hematologic/oncologic, gastrointestinal, or musculoskeletal diseases requiring treatment (3) Subjects with hypertension at the time of screening (4) Subjects with major depressive disorder, bipolar affective disorder, schizophrenia, dementia, or delusional disorder (5) Subjects with insomnia (6) Subjects with a history or current presence of renal failure, heart failure, myocardial infarction, or stroke (7) Subjects who are unable to perform physical exercise (8) Subjects with a history of clinically significant hypersensitivity to ginseng or red ginseng components (9) Subjects who have ingested medications, herbal medicines, or health functional foods related to fatigue improvement within 1 month prior to the screening test (10) Subjects who have experience ingesting ergogenic aids (exercise performance enhancers) within 2 weeks prior to the screening test (11) Subjects who have received antipsychotic drug therapy within 2 months prior to the screening test (12) Subjects with a history or suspicion of alcoholism or drug abuse (13) Subjects who have participated in other clinical trials within 3 months prior to the screening test (14) Women who are pregnant or lactating (15) Women of childbearing potential who do not agree to use appropriate methods of contraception (16) Subjects deemed unsuitable for study participation by the principal investigator due to laboratory test results or other clinical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue severity scale;Blood fatigue indicators | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Exercise duration;Antioxidant indicators;Safety outcomes: Adverse events, laboratory tests, vital signs, physical examination, and electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo Jung Park
Woosuk University Korean Medicine Medical Center
Outcome results
None listed