FatiguePhase 4NCT02331589
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
A Phase 4 study testing KRG (Korea Red ginseng) in people with Fatigue, run by Chuncheon Sacred Heart Hospital.
Trial summary
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue. Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatigue
- What is being tested?
- KRG (Korea Red ginseng)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis
Who cannot join
- viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
About this study
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.
Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
Read the detailed description
Fatigue Severity Scale
We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.
- Conditions
- Fatigue
- Being tested
- KRG (Korea Red ginseng), Placebo (for KRG)
- Keywords
- Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin
- Medical subject headings
- Fatigue, Hepatitis, Chronic, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRG (Korea Red ginseng)Drug
Also called Korea Red ginseng capsule (3,000 mg/day)
3 weeks of KRG capsule (3,000 mg/day)
Placebo (for KRG)Drug
Also called Placebo
Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
| Study group | Role | What they receive |
|---|---|---|
| Korea Red Ginseng (KRG) | Active comparator | KRG capsule (3,000 mg/day) for 3 weeks Receives: Drug: KRG (Korea Red ginseng) |
| Placebo (for KRG) | Placebo comparator | placebo (for KRG) for 3 weeks Receives: Drug: Placebo (for KRG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Enzymes
aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase
Measured: 3 weeks of KRG
Secondary outcomes (3)
Fatigue as Measured by KRUPP's Fatigue Severity Scale
KRUPP's fatigue severity scale.
The survey has nine questions as following:
- my motivation is lower, when I am fatigued
- exercise brings on my fatigue
- I am easily fatigued
- fatigue interferes with my physical functioning
- fatigue causes frequent problems for me
- my fatigue prevents sustained physical functioning
- fatigue interferes with carrying out certain duties and responsibilities
- fatigue is among my 3 most disabling symptoms
- fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree).
Scores range from 9 to 63, with higher scores indicating higher fatigue
Measured: 3 weeks of KRG
Pro-inflammatory Cytokine
tumor necrosis factor-alpha, interleukin-6
Measured: 3 weeks of KRG
Adiponectin
enzyme-linked immunosorbent assay
Measured: 3 weeks of KRG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FatigueStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331589
- Sponsor's protocol ID
- AFEKRG
- Status last verified
- Dec 2014
- First submitted
- 31 Dec 2014
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02331589
- Acronym / sponsor ID
- AFEKRG
- Conditions
- Fatigue
- Keywords
- Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.
Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
Detailed description
Fatigue Severity Scale
We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korea Red Ginseng (KRG) | Active comparator | Drug: KRG (Korea Red ginseng)KRG capsule (3,000 mg/day) for 3 weeks |
| Placebo (for KRG) | Placebo comparator | Drug: Placebo (for KRG)placebo (for KRG) for 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis
Key exclusion criteria (1 listed)
- viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
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 |
|---|---|---|
| KRG (Korea Red ginseng)Also: Korea Red ginseng capsule (3,000 mg/day)3 weeks of KRG capsule (3,000 mg/day) | Drug | Korea Red Ginseng (KRG) |
| Placebo (for KRG)Also: PlaceboPlacebos with same shape and size were manufactured and at Korea Ginseng Corporation | Drug | Placebo (for KRG) |
Primary outcome
Liver Enzymes
Time frame: 3 weeks of KRG
aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase
3 secondary outcomes
Fatigue as Measured by KRUPP's Fatigue Severity Scale
Time frame: 3 weeks of KRG
Pro-inflammatory Cytokine
Time frame: 3 weeks of KRG
Adiponectin
Time frame: 3 weeks of KRG
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KRG (Korea Red ginseng) in people with Fatigue, run by Chuncheon Sacred Heart Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Enzymes (time frame: 3 weeks of KRG). 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 10 Feb 2015.