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| Name | Class |
|---|---|
| The Korean Society of Ginseng | OTHER |
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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.
Primary objective
: Improvement of fatigue after using KRG in patients with rheumatic diseases according to
Secondary objectives
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRG group | Active Comparator |
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| Placebo group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean Red Ginseng | Dietary Supplement | Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoon-Kyoung Sung, MD, PhD, MPH | Contact | 82-2-2290-9250 | sungyk@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yoon-Kyoung Sung, MD, PhD, MPH | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University | Recruiting | Seoul | 04763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29719460 | Background | 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. |
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IPD is not shared with other researchers
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.
| 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. |
|
Improvement of ESSDAI after using KRG |
| 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]) | Improvement of EQ-5D after using KRG | 12 weeks |
| D014987 |
| Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |