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

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02847845
• Other study ID #: B080017-KCT0001935
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 27, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: DongGuk University
• Contact: Eun Jung Kim, Ph.D
• Phone: +82-31-710-3751
• Email: hanijjung[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Dietary Supplement:
• red ginseng powder capsule
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
• 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

Locations

Country	Name	City	State
Korea, Republic of	Dongguk university Bundang Oriental Hospital	Seongnam-si	Gyeonggi-do,

Sponsors (1)

Lead Sponsor	Collaborator
Eun Jung Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'	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	No
Secondary	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	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	No
Secondary	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	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	No
Secondary	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).	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	No
Secondary	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.	at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit	No
Secondary	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	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	No
Secondary	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	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	No
Secondary	derivatives of Reactive Oxygen Metabolites (d-ROMs) change	measure antioxidant levels in blood	at 2(baseline) and 5(after 6 weeks of administration) visit	No
Secondary	Biological Antioxidant Potential (BAP) change	measure antioxidant levels in blood	at 2(baseline) and 5(after 6 weeks of administration) visit	No
Secondary	Thiobarbituric Reactive Acid Substances(TBARs) change	measure antioxidant levels in blood	at 2(baseline) and 5(after 6 weeks of administration) visit	No
Secondary	Superoxide Dismutase(SOD) change	measure antioxidant levels in blood	at 2(baseline) and 5(after 6 weeks of administration) visit	No
Secondary	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	at 2(baseline) and 5(after 6 weeks of administration) visit	No
Secondary	ginseng subjective symptoms questionnaire change	ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng	at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit	Yes
Secondary	check abnormal responses		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	Yes