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

NCT02847845 | Unknown DMC

• 1 other identifier: B080017-KCT0001935
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Fatigue Syndrome

Keywords

chronic fatigue syndrome; idiopathic chronic fatigue; red ginseng; cortisol; anti-oxidant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• fatigue severity scale change

  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

  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

• a short form of stress response inventory,SRI-short form change

  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

• beck depression inventory, BDI change

  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

  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

Study Arms (2)

Red ginseng powder capsule

EXPERIMENTAL

People in this group take a red ginseng powder capsule.

Dietary Supplement: red ginseng powder capsule

Placebo powder capsule

PLACEBO COMPARATOR

People in this group take a placebo powder capsule.

Dietary Supplement: Placebo

Interventions

red ginseng powder capsule DIETARY_SUPPLEMENT

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

Red ginseng powder capsule

Placebo 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

Placebo powder capsule

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 19 years of age, but below 65 years of age
• A subject who appear repetitive or continuous fatigue of unknown cause.
• 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
• A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial

You may not qualify if:

• A subject who has history or PI for chronic fatigue
• A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc.
• Pregnant, lactating women or a subject who has plan pregnancy.
• A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks.
• A subject who has night duty, shift work or heavy work
• A subject who is judged as being not fit by a specialist

Sponsors & Collaborators

• Eun Jung Kim: lead

Study Sites (1)

Dongguk university Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, 13601, South Korea

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eun Jung Kim, Ph.D

  DongGuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Jung Kim, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 28, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

KR (1)