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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng

Intervention / Treatment
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* Dietary Supplement: Korean Red Ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KRG group<br>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) | Dietary Supplement: Korean Red Ginseng<br>* Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.<br>* Other names: KRG;|
| Placebo Comparator: Placebo group<br>Enrollment: 60 patients Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) | Improvement of FACIT-F after using KRG | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued]) | Improvement of FACIT-VAS after using KRG | 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) | Improvement of ESSDAI after using KRG | 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]) | Improvement of EQ-5D after using KRG | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjögren's Syndrome, Korean Red Ginseng