Clinical trial NCT03983408: Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
Official title: Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sjögren's Syndrome
Rheumatic Diseases
Korean Red Ginseng
Keywords: Sjögren's Syndrome
Korean Red Ginseng
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: The Korean Society of Ginseng
First posted: 2019-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])
timeFrame: 12 weeks
measure: ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity)
timeFrame: 12 weeks
measure: 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])
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
affiliation: Hanyang University
name: Yoon-Kyoung Sung, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho SK, Kim D, Yoo D, Jang EJ, Jun JB, Sung YK. Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study. J Ginseng Res. 2018 Apr;42(2):144-148. doi: 10.1016/j.jgr.2017.01.006. Epub 2017 Jan 20.