Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
时间窗: 12 weeks
Improvement of FACIT-F after using KRG
次要结局
- 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)
研究者
Yoon-Kyoung Sung
Professor
Hanyang University