Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hanyang University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
Study Overview
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
- Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
KRG group
- 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)
Intervention: Korean Red Ginseng (Dietary Supplement)
Placebo group
- Enrollment: 60 patients
- Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
Time Frame: 12 weeks
Improvement of FACIT-F after using KRG
Secondary Outcomes
- Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])(12 weeks)
- 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)
- 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)
Investigators
Yoon-Kyoung Sung
Professor
Hanyang University