Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases.

Primary objective

: Improvement of fatigue after using KRG in patients with rheumatic diseases according to

Secondary objectives

1. Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)
2. Improvement of quality of life after using KRG in patients with rheumatic diseases according to EuroQol 5 dimensions questionnaire (EQ-5D)

The study population will be adult patients with rheumatic diseases, especially primary or secondary Sjögren's syndrome who have experienced dryness for more than 3 months. Participants are ramdomly assigned to KRG and placebo group and they are using KRG or placebo for the first 12 weeks. After 12 weeks, the concealment of allocation is lifted and all patients are provided with KRG for next 12 weeks with open-label extension study

Inclusion Criteria:

• Patients who meet for Classification Criteria for Sjögren's syndrome
• Patients who have experienced fatigue for over 3 months
• Patients aged ≥ 19 and <75
• Patients who provide a written consent of participating in this study.

Exclusion Criteria:

• Patients who have experienced hypersensitivity or adverse events to Korean Red ginseng
• Patients who used dietary supplements containing KRG during recent 2 months
• Patients who are pregnant or breast-feeding
• Patients who use oral glucocorticoids or opioids continuously
• Patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression.
• Patients having fibromyalgia or chronic fatigue syndrome
• Patients who presented abnormal laboratory findings at the time of enrollment White blood cell (WBC) ≤ 3.5 x 10^9/L or, Hemoglobin (Hb) ≤ 8.5 g/dL or, Platelet (PLT) ≤ 100 x 10^9/L or, Serum creatinine (Cr) ≥ 2.0 mg/dL or, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥ 2.5 times of upper limits of normal