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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03983408 |
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Date of registration:
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10/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
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Scientific title:
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Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease |
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Date of first enrolment:
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June 17, 2019 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03983408 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Yoon-Kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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82-2-2290-9250 |
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Email:
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sungyk@hanyang.ac.kr |
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Affiliation:
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Name:
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Yoon-Kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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82-2-2290-9250 |
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Email:
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sungyk@hanyang.ac.kr |
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Affiliation:
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Name:
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Yoon-Kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hanyang University |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatic Diseases
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Sjögren's Syndrome
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Korean Red Ginseng
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Intervention(s)
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Dietary Supplement: Korean Red Ginseng
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Dietary Supplement: Placebo
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Primary Outcome(s)
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The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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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]
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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]
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Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])
[Time Frame: 12 weeks]
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Secondary ID(s)
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HUHRD-SPE-19-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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