An interventional study of red ginseng powder capsule and Placebo in Chronic Fatigue Syndrome, sponsored by Eun Jung Kim. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-28.
Sponsored by Eun Jung Kim · Not applicable, Interventional, and Supportive care
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The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.
Verify the efficacy and safety after taking red ginseng for chronic fatigue syndrome or idiopathic chronic fatigue patient. They were verified through not only survey like VAS change about fatigue, fatigue severity scale, Chalder fatigue severity questionnaire, SRI-short form , BDI , ISI EQ-5D-5L, ginseng subjective symptoms questionnaire but also an anti-oxidant test and a salivary cortisol test after 6 weeks after taking red ginseng or placebo drugs.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Eun Jung Kim is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People in this group take a red ginseng powder capsule.
Dietary Supplement: red ginseng powder capsule
People in this group take a placebo powder capsule.
Dietary Supplement: Placebo
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
100mm visual analogue scale(VAS) about fatigue change
The patient is asked to indicate their perceived fatigue intensity along a 100 mm horizontal line, where '0' represents 'no fatigue' and '100', 'unbearable fatigue'
Time frame: at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
fatigue severity scale change
The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
Chalder fatigue severity questionnaire change
The Chalder fatigue severity questionnaire is composed of 11 questions about fatigue. Grading of each item ranges from 0 to 9, where 0 indicate non-fatigue and 9 strong fatigue
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
a short form of stress response inventory,SRI-short form change
SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression).
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
beck depression inventory, BDI change
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity.
Time frame: at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
insomnia severity index, ISI change
The ISI is composed of seven items assessing recent problems with sleep onset, sleep maintenance and early morning awakening, interference of sleep problems with daily functioning and perceived prominence of impairment attributed to the sleep problem, concern about sleep problems and satisfaction with sleep patterns. Perceived severity of each item is rated on a 0-4 scale and a total score, which ranges from 0 to 28 obtains from summing the items ratings
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change
The EuroQOL - 5 Dimensions (EQ-5D) was employed for measuring health-related quality of life. It consisted of a weighted sum of five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression, which provided a simple descriptive profile and a single index value for health status . We used a recently developed version, the EQ-5D-5L, which includes five-level response options: no problems, slight problems, moderate problems, severe problems, and extreme problems
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
derivatives of Reactive Oxygen Metabolites (d-ROMs) change
measure antioxidant levels in blood
Time frame: at 2(baseline) and 5(after 6 weeks of administration) visit
Biological Antioxidant Potential (BAP) change
measure antioxidant levels in blood
Time frame: at 2(baseline) and 5(after 6 weeks of administration) visit
Thiobarbituric Reactive Acid Substances(TBARs) change
measure antioxidant levels in blood
Time frame: at 2(baseline) and 5(after 6 weeks of administration) visit
Superoxide Dismutase(SOD) change
measure antioxidant levels in blood
Time frame: at 2(baseline) and 5(after 6 weeks of administration) visit
Stress hormone test
measure cortisol level in saliva First saliva sample : 07:00-09:00 (within 30 minutes after waking up) Second saliva sample : 11:00-13:00 Third saliva sample : 16:00-18:00 fourth saliva sample : 22:00-00:00
Time frame: at 2(baseline) and 5(after 6 weeks of administration) visit
ginseng subjective symptoms questionnaire change
ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng
Time frame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit
check abnormal responses
Time frame: at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jun 2016, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Asian ginseng
Eun Jung Kim