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Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.
Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
Fatigue Severity Scale
We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korea Red Ginseng (KRG) | Active Comparator | KRG capsule (3,000 mg/day) for 3 weeks |
|
| Placebo (for KRG) | Placebo Comparator | placebo (for KRG) for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRG (Korea Red ginseng) | Drug | 3 weeks of KRG capsule (3,000 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Enzymes | aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase | 3 weeks of KRG |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue as Measured by KRUPP's Fatigue Severity Scale | KRUPP's fatigue severity scale. The survey has nine questions as following:
Scores range from 9 to 63, with higher scores indicating higher fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Korea Red Ginseng (KRG) | KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day) |
| FG001 | Placebo (for KRG) | placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Korea Red Ginseng (KRG) | KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day) |
| BG001 | Placebo (for KRG) | placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Liver Enzymes | aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase | Posted | Mean | Standard Deviation | U/L | 3 weeks of KRG |
|
Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Korea Red Ginseng (KRG) | KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ki Tae Suk | Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea | +82-33-240-5826 | ktsuk@hallym.ac.kr |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D006521 | Hepatitis, Chronic |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
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| Placebo (for KRG) | Drug | Placebos with same shape and size were manufactured and at Korea Ginseng Corporation |
|
|
| 3 weeks of KRG |
| Pro-inflammatory Cytokine | tumor necrosis factor-alpha, interleukin-6 | 3 weeks of KRG |
| Adiponectin | enzyme-linked immunosorbent assay | 3 weeks of KRG |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Fatigue as Measured by KRUPP's Fatigue Severity Scale | KRUPP's fatigue severity scale. The survey has nine questions as following:
Scores range from 9 to 63, with higher scores indicating higher fatigue | Posted | Mean | Standard Deviation | scores on a scale | 3 weeks of KRG |
|
|
|
| Secondary | Pro-inflammatory Cytokine | tumor necrosis factor-alpha, interleukin-6 | Posted | Mean | Standard Deviation | pg/mL | 3 weeks of KRG |
|
|
|
| Secondary | Adiponectin | enzyme-linked immunosorbent assay | Posted | Mean | Standard Deviation | pg/mL | 3 weeks of KRG |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo (for KRG) | placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation | 0 | 0 | 0 | 0 |
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| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D005234 | Fatty Liver |