None listed
Conditions
Interventions
Dietary Supplement : Korean red ginseng extracts and placebo(cellulose) twice daily, 1000mg(500mg X 2 tablets) per time orally 30 minutes before the meal in an empty stomach every morning and evening
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Person who agreed to participate in this study and signed voluntarily on the written informed consent form 2)Person who has a diagnosis of adult-onset rhumatoid arthritis as defined by the American College of Rheumatology(ACR) 1987 Criteria or the American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 Criteria 3)Person who aged between 18 and 80 4)Person who has low disease active score(below 3.2) defined as the 28-joints Disease Assessment Score(DAS 28) 5)The dose of disease modifying antirheumatic drugs(DMARDs) must have been stable for at least the 8 weeks prior to study entry.
Exclusion criteria
Exclusion criteria: 1)A Pregnant or a breast-feeding woman 2)Person who has taken a functional food contains ginseng components in 2 months 3)Person who has a experience of hypersensitivity to a functional food contains ginseng components 4)Person who has taken contraindicated drug ·Anti-thrombus drugs: anticoagulants, anti-platelet agents, thrombolytic agents etc ·Psychiatric drugs ·Insulin, sulphonylurea drugs ·Regular stroidcorticoids ·Herb Extracts ·Other health functional foods 5)Person who has a laboratory abnormality ·White Blood Cell = 3.5 x ?10?^9/L ·Hemoglobin = 8.5 g/dL ·Platelet = 100 x ?10?^9/L ·Creatinine= 2.0 mg/dL ·Aspartate aminotransferase(AST) or Alanine aminotransferase(ALT) = 2.5 times of upper limits of normal(ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistency in low disease activity score based on the 28-joint Disease Activity Score (DAS 28) before and after 8 and 16 weeks of trial drug intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Analogue Scale (VAS) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score before and after 8 and 16 weeks of trial drug intake;Change in Health Assessment Questionnaire(HAQ) total score before and after 8 and 16 weeks of trial drug intake | — |
Countries
Korea, Republic of
Contacts
Public ContactDasomi Yoo
Hanyang University Seoul Hospital
Outcome results
None listed