Chronic Fatigue SyndromeNCT02847845
A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
A study testing red ginseng powder capsule in people with Chronic Fatigue Syndrome, run by Eun Jung Kim at 1 site in South Korea.
Trial summary
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- red ginseng powder capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk university Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, 13601
Eun Jung Kim, Ph.D, +82-31-710-3751, hanijjung@naver.com
About this study
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- red ginseng powder capsule, Placebo
- Keywords
- chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red ginseng powder capsuleDietary supplement
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
PlaceboDietary supplement
Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
| Study group | Role | What they receive |
|---|---|---|
| Red ginseng powder capsule | Experimental | People in this group take a red ginseng powder capsule. Receives: Dietary Supplement: red ginseng powder capsule |
| Placebo powder capsule | Placebo comparator | People in this group take a placebo powder capsule. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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 outcomes (13)
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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: at 2(baseline) and 5(after 6 weeks of administration) visit
Biological Antioxidant Potential (BAP) change
measure antioxidant levels in blood
Measured: at 2(baseline) and 5(after 6 weeks of administration) visit
Thiobarbituric Reactive Acid Substances(TBARs) change
measure antioxidant levels in blood
Measured: at 2(baseline) and 5(after 6 weeks of administration) visit
Superoxide Dismutase(SOD) change
measure antioxidant levels in blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Jung Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eun Jung Kim, DongGuk University
- Investigators
- Eun Jung Kim, Ph.D, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847845
- Sponsor's protocol ID
- B080017-KCT0001935
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
- ClinicalTrials.gov ID
- NCT02847845
- Acronym / sponsor ID
- B080017-KCT0001935
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eun Jung KimUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red ginseng powder capsule | Experimental | Dietary Supplement: red ginseng powder capsulePeople in this group take a red ginseng powder capsule. |
| Placebo powder capsule | Placebo comparator | Dietary Supplement: PlaceboPeople in this group take a placebo powder capsule. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red ginseng powder capsuleusage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks | Dietary supplement | Red ginseng powder capsule |
| PlaceboControl (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks | Dietary supplement | Placebo powder capsule |
Primary outcome
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'
13 secondary outcomes
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
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
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
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
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
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
derivatives of Reactive Oxygen Metabolites (d-ROMs) change
Time frame: 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
Thiobarbituric Reactive Acid Substances(TBARs) change
Time frame: 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
Stress hormone test
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Jung Kim, Ph.D principal investigator
DongGuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing red ginseng powder capsule in people with Chronic Fatigue Syndrome, run by Eun Jung Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Jung Kim, Ph.D (+82-31-710-3751, hanijjung@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.