Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng
Conditions
Keywords
Sjögren's Syndrome, Korean Red Ginseng
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
Interventions
DIETARY_SUPPLEMENTKorean Red Ginseng
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets. Participants are parovided with 2 placebo tablets twice a day for first 12 weeks, following Korean Red Ginseng extract tablets twice a day for another 12 weeks.
Sponsors
The Korean Society of Ginseng
Hanyang University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, 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
Sex/Gender
ALL
Age
19 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYoon-Kyoung Sung, MD, PhD, MPH
Outcome results
None listed