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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983408
• Other study ID #: HUHRD-SPE-19-01
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2020
• Source: Hanyang University
• Contact: Yoon-Kyoung Sung, MD, PhD, MPH
• Phone: 82-2-2290-9250
• Email: sungyk[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fatigue
• Korean Red Ginseng
• Rheumatic Diseases
• Sjogren's Syndrome
• Sjögren's Syndrome

Intervention

Dietary Supplement:
• Korean Red Ginseng
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
• Placebo
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.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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