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

Primary Purpose

Chronic Fatigue Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
red ginseng powder capsule
Placebo
Sponsored by
Eun Jung Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Fatigue Syndrome focused on measuring chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dongguk university Bundang Oriental HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Red ginseng powder capsule

Placebo powder capsule

Arm Description

People in this group take a red ginseng powder capsule.

People in this group take a placebo powder capsule.

Outcomes

Primary Outcome Measures

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'

Secondary Outcome Measures

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
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
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).
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.
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
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
derivatives of Reactive Oxygen Metabolites (d-ROMs) change
measure antioxidant levels in blood
Biological Antioxidant Potential (BAP) change
measure antioxidant levels in blood
Thiobarbituric Reactive Acid Substances(TBARs) change
measure antioxidant levels in blood
Superoxide Dismutase(SOD) change
measure antioxidant levels in blood
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
ginseng subjective symptoms questionnaire change
ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng
check abnormal responses

Full Information

First Posted
July 5, 2016
Last Updated
July 27, 2016
Sponsor
Eun Jung Kim
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1. Study Identification

Unique Protocol Identification Number
NCT02847845
Brief Title
A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Official Title
A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun Jung Kim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Red ginseng powder capsule
Arm Type
Experimental
Arm Description
People in this group take a red ginseng powder capsule.
Arm Title
Placebo powder capsule
Arm Type
Placebo Comparator
Arm Description
People in this group take a placebo powder capsule.
Intervention Type
Dietary Supplement
Intervention Name(s)
red ginseng powder capsule
Intervention Description
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
100mm visual analogue scale(VAS) about fatigue change
Description
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
Secondary Outcome Measure Information:
Title
fatigue severity scale change
Description
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
Title
Chalder fatigue severity questionnaire change
Description
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
Title
a short form of stress response inventory,SRI-short form change
Description
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
Title
beck depression inventory, BDI change
Description
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
Title
insomnia severity index, ISI change
Description
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
Title
EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change
Description
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
Title
derivatives of Reactive Oxygen Metabolites (d-ROMs) change
Description
measure antioxidant levels in blood
Time Frame
at 2(baseline) and 5(after 6 weeks of administration) visit
Title
Biological Antioxidant Potential (BAP) change
Description
measure antioxidant levels in blood
Time Frame
at 2(baseline) and 5(after 6 weeks of administration) visit
Title
Thiobarbituric Reactive Acid Substances(TBARs) change
Description
measure antioxidant levels in blood
Time Frame
at 2(baseline) and 5(after 6 weeks of administration) visit
Title
Superoxide Dismutase(SOD) change
Description
measure antioxidant levels in blood
Time Frame
at 2(baseline) and 5(after 6 weeks of administration) visit
Title
Stress hormone test
Description
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
Title
ginseng subjective symptoms questionnaire change
Description
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 19 years of age, but below 65 years of age A subject who appear repetitive or continuous fatigue of unknown cause. 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 A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial Exclusion Criteria: A subject who has history or PI for chronic fatigue A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc. Pregnant, lactating women or a subject who has plan pregnancy. A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks. A subject who has night duty, shift work or heavy work A subject who is judged as being not fit by a specialist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Jung Kim, Ph.D
Phone
+82-31-710-3751
Email
hanijjung@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Jung Kim, Ph.D
Organizational Affiliation
DongGuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk university Bundang Oriental Hospital
City
Seongnam-si
State/Province
Gyeonggi-do,
ZIP/Postal Code
13601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Jung Kim, Ph.D
Phone
+82-31-710-3751
Email
hanijjung@naver.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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