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出境医 / 临床实验 / Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

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

Study Description
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

Study Design
Layout table for study information
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: KRG group
  • 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
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
Other Name: KRG

Placebo Comparator: Placebo group
  • Enrollment: 60 patients
  • Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks
Dietary Supplement: 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.

Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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 Recruiting
Seoul, Korea, Republic of, 04763
Contact: Yoon-Kyoung Sung, MD, PhD, MPH    82-2-2290-9250    sungyk@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University
The Korean Society of Ginseng
Investigators
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Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH Hanyang University
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) [ Time Frame: 12 weeks ]
Improvement of FACIT-F after using KRG
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Fatigue visual analogue scale (VAS) [ Time Frame: 12 weeks ]
    Improvement of FACIT-VAS after using KRG
  • ESSDAI [ Time Frame: 12 weeks ]
    Improvement of ESSDAI after using KRG
  • EuroQol 5 dimensions questionnaire (EQ-5D) [ Time Frame: 12 weeks ]
    Improvement of EQ-5D after using KRG
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
Official Title  ICMJE Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Sjögren's Syndrome
  • Rheumatic Diseases
  • Korean Red Ginseng
Intervention  ICMJE
  • Dietary Supplement: Korean Red Ginseng
    Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
    Other Name: KRG
  • Dietary Supplement: 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.
Study Arms  ICMJE
  • Active Comparator: KRG group
    • 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)
    Intervention: Dietary Supplement: Korean Red Ginseng
  • Placebo Comparator: Placebo group
    • Enrollment: 60 patients
    • Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yoon-Kyoung Sung, MD, PhD, MPH 82-2-2290-9250 sungyk@hanyang.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983408
Other Study ID Numbers  ICMJE HUHRD-SPE-19-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD is not shared with other researchers
Responsible Party Yoon-Kyoung Sung, Hanyang University
Study Sponsor  ICMJE Hanyang University
Collaborators  ICMJE The Korean Society of Ginseng
Investigators  ICMJE
Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH Hanyang University
PRS Account Hanyang University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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