Fatigue
Conditions
Keywords
Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin
Brief summary
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.
Detailed description
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.
Interventions
DRUGKRG (Korea Red ginseng)
3 weeks of KRG capsule (3,000 mg/day)
DRUGPlacebo (for KRG)
Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis
Exclusion criteria
* viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Enzymes | 3 weeks of KRG | aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue as Measured by KRUPP's Fatigue Severity Scale | 3 weeks of KRG | 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). Scores range from 9 to 63, with higher scores indicating higher fatigue |
| Pro-inflammatory Cytokine | 3 weeks of KRG | tumor necrosis factor-alpha, interleukin-6 |
| Adiponectin | 3 weeks of KRG | enzyme-linked immunosorbent assay |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 34 |
| 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 | 31 |
| Total | 65 |
Baseline characteristics
| Characteristic | Placebo (for KRG) | Korea Red Ginseng (KRG) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 31 Participants | 58 Participants |
| Age, Continuous | 50.0 years STANDARD_DEVIATION 12.8 | 45.8 years STANDARD_DEVIATION 12.7 | 47.8 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Korea, Republic of | 31 participants | 34 participants | 65 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Liver Enzymes
aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase
Time frame: 3 weeks of KRG
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Korea Red Ginseng (KRG) | Liver Enzymes | aspartate aminotransferase | 52.1 U/L | Standard Deviation 30.7 |
| Korea Red Ginseng (KRG) | Liver Enzymes | alanine aminotransferase | 81.0 U/L | Standard Deviation 43.7 |
| Korea Red Ginseng (KRG) | Liver Enzymes | gamma glutamyl transferase | 106.9 U/L | Standard Deviation 68.6 |
| Korea Red Ginseng (KRG) | Liver Enzymes | lactate dehydrogenase | 226.7 U/L | Standard Deviation 99 |
| Placebo (for KRG) | Liver Enzymes | lactate dehydrogenase | 218.6 U/L | Standard Deviation 34.1 |
| Placebo (for KRG) | Liver Enzymes | aspartate aminotransferase | 59.1 U/L | Standard Deviation 37.2 |
| Placebo (for KRG) | Liver Enzymes | gamma glutamyl transferase | 139.3 U/L | Standard Deviation 198.2 |
| Placebo (for KRG) | Liver Enzymes | alanine aminotransferase | 81.6 U/L | Standard Deviation 32.2 |
Secondary
Adiponectin
enzyme-linked immunosorbent assay
Time frame: 3 weeks of KRG
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korea Red Ginseng (KRG) | Adiponectin | 7751.2 pg/mL | Standard Deviation 3108.1 |
| Placebo (for KRG) | Adiponectin | 7711.6 pg/mL | Standard Deviation 3041.3 |
Secondary
Fatigue as Measured by KRUPP's Fatigue Severity Scale
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). Scores range from 9 to 63, with higher scores indicating higher fatigue
Time frame: 3 weeks of KRG
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korea Red Ginseng (KRG) | Fatigue as Measured by KRUPP's Fatigue Severity Scale | 33.0 scores on a scale | Standard Deviation 11.6 |
| Placebo (for KRG) | Fatigue as Measured by KRUPP's Fatigue Severity Scale | 29.8 scores on a scale | Standard Deviation 14.1 |
Secondary
Pro-inflammatory Cytokine
tumor necrosis factor-alpha, interleukin-6
Time frame: 3 weeks of KRG
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Korea Red Ginseng (KRG) | Pro-inflammatory Cytokine | tumor necrosis factor-alpha | 108.0 pg/mL | Standard Deviation 54.8 |
| Korea Red Ginseng (KRG) | Pro-inflammatory Cytokine | interleukin-6 | 2.3 pg/mL | Standard Deviation 1.9 |
| Placebo (for KRG) | Pro-inflammatory Cytokine | tumor necrosis factor-alpha | 123.1 pg/mL | Standard Deviation 42.1 |
| Placebo (for KRG) | Pro-inflammatory Cytokine | interleukin-6 | 1.5 pg/mL | Standard Deviation 0.4 |