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

July 27, 2016 updated by: Eun Jung Kim
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Gyeonggi-do,
      • Seongnam-si, Gyeonggi-do,, Korea, Republic of, 13601
        • Recruiting
        • Dongguk University Bundang Oriental Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Red ginseng powder capsule
People in this group take a 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.
Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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).
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
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.
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
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
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
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
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
Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure antioxidant levels in blood
at 2(baseline) and 5(after 6 weeks of administration) visit
Biological Antioxidant Potential (BAP) change
Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure antioxidant levels in blood
at 2(baseline) and 5(after 6 weeks of administration) visit
Thiobarbituric Reactive Acid Substances(TBARs) change
Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure antioxidant levels in blood
at 2(baseline) and 5(after 6 weeks of administration) visit
Superoxide Dismutase(SOD) change
Time Frame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure antioxidant levels in blood
at 2(baseline) and 5(after 6 weeks of administration) visit
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

at 2(baseline) and 5(after 6 weeks of administration) visit
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Eun Jung Kim, Ph.D, DongGuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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