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

Eun Jung Kim

Status: Unknown

Conditions: Chronic Fatigue Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: red ginseng powder capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02847845

B080017-KCT0001935

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Red ginseng powder capsule

Experimental group

Description:

People in this group take a red ginseng powder capsule.

Treatment:

Dietary Supplement: red ginseng powder capsule

Placebo powder capsule

Placebo Comparator group

Description:

People in this group take a placebo powder capsule.

Treatment:

Dietary Supplement: Placebo