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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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

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Detailed Description

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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

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Chronic Fatigue Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Red ginseng powder capsule

People in this group take a red ginseng powder capsule.

Group Type EXPERIMENTAL

red ginseng powder capsule

Intervention Type DIETARY_SUPPLEMENT

usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks

Placebo powder capsule

People in this group take a placebo powder capsule.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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

Interventions

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red ginseng powder capsule

usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes