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Fatigue is a common feature in patients with rheumatic conditions. Fatigue can lead to a decline in physical function, self-confidence, cognitive status, and work performance and significantly impact the quality of life. While pain and inflammation of arthritis can be well controlled nowadays attributed to the advances in anti-rheumatic medications, fatigue remains a challenge. Even with proper therapies for arthritis, the prevalence of severe fatigue is more than 30%, which is a significant burden to both physicians and patients. However, there is no regimen to alleviate fatigue among patients with inflammatory arthritis. Finding a way to combat fatigue will significantly help improve patients' physical and mental state and family society.
To investigate the efficacy of Jing Si Herbal Tea Liquid Packets on fatigue in patients with inflammatory arthritis, the investigators propose a two-year research project to recruit approximately 150 patients with fatigue and inflammatory arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. This project is designed as a randomized, double-blind, placebo-controlled study. The recruited patients will be randomized to receive Jing Si Herbal Tea Liquid Packets or a matching placebo in combination with the background regular anti-rheumatic therapy. The severity of fatigue will be obtained by questionnaire. Clinical parameters, including demographic data and disease activities, will be collected during each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jing Si Herbal Tea LIQUID PACKETS | Experimental | one packet oral twice daily for three months |
|
| Placebo | Placebo Comparator | one packet oral twice daily for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jing Si Herbal Tea LIQUID PACKETS | Dietary Supplement | intake Jing Si Herbal Tea LIQUID PACKETS twice daily for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets] | Fatigue assessment measured by the functional assessment of chronic illness Therapy- Fatigue (FACIT- F) (0-52; higher score=less fatigue) | Change of fatigue level every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity of inflammatory arthritis [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets] | Disease activity of inflammatory arthritis measured by the Disease Activity Score based on 28 joints (DAS28) (0-9.55; higher score=more active) for rheumatoid arthritis, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (0-10; higher score=more active) for ankylosing spondylitis, and Disease Activity in PSoriatic Arthritis (DAPSA) (0-204; higher score=more active) for psoriatic arthritis. |
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Inclusion Criteria:
inflammatory arthritis, any of the following diagnosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuei-Ying Su, MD,PhD | Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien City | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26272057 | Background | Overman CL, Kool MB, Da Silva JA, Geenen R. The prevalence of severe fatigue in rheumatic diseases: an international study. Clin Rheumatol. 2016 Feb;35(2):409-15. doi: 10.1007/s10067-015-3035-6. Epub 2015 Aug 15. | |
| 32745130 | Background | Esbensen BA, Stallknecht SE, Madsen ME, Hagelund L, Pilgaard T. Correlations of fatigue in Danish patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis. PLoS One. 2020 Aug 3;15(8):e0237117. doi: 10.1371/journal.pone.0237117. eCollection 2020. |
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Data obtained through this study may be provided to qualified researchers with academic interest in fatigue among patients with inflammatory arthritis. Data or samples shared will be coded, with no PHI (protected health information) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| Placebo | Dietary Supplement | intake Placebo twice daily for three months |
|
| Change of disease activity every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |