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

Hanyang University120 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

120

Conditions

Sjögren's Syndrome Rheumatic Diseases Korean Red Ginseng

Interventions

Korean Red GinsengDIETARY_SUPPLEMENT

Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hanyang University

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Central Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

CONTACT

82-2-2290-9250 sungyk@hanyang.ac.kr

Data from ClinicalTrials.gov

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