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

Eun Jung Kim50 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Chronic Fatigue Syndrome

Interventions

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dongguk university Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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'

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

Secondary Outcomes

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

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

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

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).

beck depression inventory, BDI change

Central Contacts

Eun Jung Kim, Ph.D

CONTACT

+82-31-710-3751 hanijjung@naver.com

Data from ClinicalTrials.gov

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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.

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

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

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

derivatives of Reactive Oxygen Metabolites (d-ROMs) change

measure antioxidant levels in blood