Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
- Conditions
- Rheumatic DiseasesKorean Red GinsengSjögren's Syndrome
- Interventions
- Dietary Supplement: Korean Red GinsengDietary Supplement: Placebo
- Registration Number
- NCT03983408
- Lead Sponsor
- Hanyang University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description KRG group Korean Red Ginseng * Enrollment: 60 patients * Drug: Korean Red Ginseng (KRG) 2,000 mg/day for total 24 weeks (2 Korean Red Ginseng extract tablet twice a day, ginsenoside Rg1+Rb1+Rg3 7.0 mg/g per each tablet) Placebo group Placebo * Enrollment: 60 patients * Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks
- Primary Outcome Measures
Name Time Method The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) 12 weeks Improvement of FACIT-F after using KRG
- Secondary Outcome Measures
Name Time Method Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued]) 12 weeks Improvement of FACIT-VAS after using KRG
ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity) 12 weeks Improvement of ESSDAI after using KRG
EuroQol 5 dimensions questionnaire (EQ-5D, a person's health status is defined by a 5-digit number, ranging from 11111 [having no problems in all dimensions] to 33333 [having extreme problems in all dimensions]) 12 weeks Improvement of EQ-5D after using KRG
Trial Locations
- Locations (1)
Hanyang University
🇰🇷Seoul, Korea, Republic of