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

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ClinicalTrials.gov Identifier: NCT03983408
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Yoon-Kyoung Sung, Hanyang University

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.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Rheumatic Diseases Korean Red Ginseng Dietary Supplement: Korean Red ginseng Dietary Supplement: Placebo Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.
Primary Purpose: Supportive Care
Official Title: Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
Estimated Study Start Date : June 17, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Active Comparator: KRG
  • Enrollment: 60
  • Drug: Korean Red Ginseng 2,000 mg/day (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
Participants are provided with 2 Korean Red Ginseng extract tablet twice a day for total 24 weeks.
Other Name: KRG

Placebo Comparator: Placebo
  • Enrollment: 60
  • Drug: Placebo
Dietary Supplement: Placebo
Placebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets




Primary Outcome Measures :
  1. The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) [ Time Frame: 12 weeks ]
    Improvement of FACIT-F after using KRG


Secondary Outcome Measures :
  1. Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued]) [ Time Frame: 12 weeks ]
    Improvement of FACIT-VAS after using KRG

  2. ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity) [ Time Frame: 12 weeks ]
    Improvement of ESSDAI after using KRG

  3. 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]) [ Time Frame: 12 weeks ]
    Improvement of EQ-5D after using KRG



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983408


Contacts
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Contact: Yoon-Kyoung Sung, MD, PhD, MPH 82-2-2290-9250 sungyk@hanyang.ac.kr

Locations
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Korea, Republic of
Hanyang University
Seoul, Korea, Republic of, 04763
Sponsors and Collaborators
Hanyang University
The Korean Society of Ginseng

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Responsible Party: Yoon-Kyoung Sung, Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT03983408     History of Changes
Other Study ID Numbers: HUHRD-SPE-19-01
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is not shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yoon-Kyoung Sung, Hanyang University:
Sjögren's Syndrome
Korean Red Ginseng
Additional relevant MeSH terms:
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Eye Diseases
Sjogren's Syndrome
Rheumatic Diseases
Collagen Diseases
Fatigue
Signs and Symptoms
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases