Efficacy and safety of Korean Red Ginseng for Patients with Rheumatoid Arthritis

Not Applicable

Active, not recruiting

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0001516

Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 80

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

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)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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