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

NCT03983408 | Unknown

• 1 other identifier: HUHRD-SPE-19-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjögren's Syndrome; Rheumatic Diseases; Korean Red Ginseng

Keywords

Sjögren's Syndrome; Korean Red Ginseng

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

KRG group

ACTIVE COMPARATOR

* 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

Placebo group

PLACEBO COMPARATOR

* Enrollment: 60 patients * Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks

Dietary Supplement: Placebo

Interventions

Korean Red Ginseng DIETARY_SUPPLEMENT

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

Also known as: KRG

KRG group

Placebo DIETARY_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.

Placebo group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead
• The Korean Society of Ginseng: collaborator

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

RECRUITING

Related 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.

  PMID: 29719460 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Rheumatic Diseases

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yoon-Kyoung Sung, MD, PhD, MPH

  Hanyang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 17, 2019
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)