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A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng

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ClinicalTrials.gov Identifier: NCT02847845
Recruitment Status : Unknown
Verified July 2016 by Eun Jung Kim, DongGuk University.
Recruitment status was:  Recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Eun Jung Kim, DongGuk University

Brief Summary:
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Dietary Supplement: red ginseng powder capsule Dietary Supplement: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Red ginseng powder capsule
People in this group take a red ginseng powder capsule.
Dietary Supplement: red ginseng powder capsule
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks

Placebo Comparator: Placebo powder capsule
People in this group take a placebo powder capsule.
Dietary Supplement: Placebo
Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks




Primary Outcome Measures :
  1. 100mm visual analogue scale(VAS) about fatigue change [ 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 ]
    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'


Secondary Outcome Measures :
  1. fatigue severity scale change [ 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 ]
    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

  2. Chalder fatigue severity questionnaire change [ 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 ]
    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

  3. a short form of stress response inventory,SRI-short form change [ 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 ]
    SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression).

  4. beck depression inventory, BDI change [ Time Frame: at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit ]
    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.

  5. insomnia severity index, ISI change [ 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 ]
    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

  6. EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change [ 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 ]
    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

  7. derivatives of Reactive Oxygen Metabolites (d-ROMs) change [ Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit ]
    measure antioxidant levels in blood

  8. Biological Antioxidant Potential (BAP) change [ Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit ]
    measure antioxidant levels in blood

  9. Thiobarbituric Reactive Acid Substances(TBARs) change [ Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit ]
    measure antioxidant levels in blood

  10. Superoxide Dismutase(SOD) change [ Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit ]
    measure antioxidant levels in blood

  11. Stress hormone test [ Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit ]

    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


  12. ginseng subjective symptoms questionnaire change [ 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 ]
    ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng

  13. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. At least 19 years of age, but below 65 years of age
  2. A subject who appear repetitive or continuous fatigue of unknown cause.
  3. A subject who has not abnormal findings of blood pressure, complete blood cell count(Hb, Hct, WBC, glucose), biochemical examination(AST, ALT, creatinine), thyroid gland function test(TSH, FT4), Urine test(Urine glucose, Urine protein), Chest X-ray, and ECG for causing fatigue
  4. A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial

Exclusion Criteria:

  1. A subject who has history or PI for chronic fatigue
  2. A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc.
  3. Pregnant, lactating women or a subject who has plan pregnancy.
  4. A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks.
  5. A subject who has night duty, shift work or heavy work
  6. A subject who is judged as being not fit by a specialist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847845


Contacts
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Contact: Eun Jung Kim, Ph.D +82-31-710-3751 hanijjung@naver.com

Locations
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Korea, Republic of
Dongguk university Bundang Oriental Hospital Recruiting
Seongnam-si, Gyeonggi-do,, Korea, Republic of, 13601
Contact: Eun Jung Kim, Ph.D    +82-31-710-3751    hanijjung@naver.com   
Sponsors and Collaborators
Eun Jung Kim
Investigators
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Principal Investigator: Eun Jung Kim, Ph.D DongGuk University

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Responsible Party: Eun Jung Kim, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier: NCT02847845     History of Changes
Other Study ID Numbers: B080017-KCT0001935
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eun Jung Kim, DongGuk University:
chronic fatigue syndrome
idiopathic chronic fatigue
red ginseng
cortisol
anti-oxidant
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases