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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eun Jung Kim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B080017-KCT0001935

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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