The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis

Conditions
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Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Fatigue

Intervention / Treatment
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* Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inflammatory arthritis, any of the following diagnosis Rheumatoid arthritis, based on ACR (American College of Rheumatology) classification criteria Ankylosing spondylitis, based on modified New York Criteria Psoriatic arthritis, based on 2006 CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria Exclusion Criteria: active infection or chronic infection uncontrolled disease status of inflammatory arthritis unwilling to take herbal tea with difficulty for return visits

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jing Si Herbal Tea LIQUID PACKETS<br>one packet oral twice daily for three months | Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS<br>* intake Jing Si Herbal Tea LIQUID PACKETS twice daily for three months<br>|
| Placebo Comparator: Placebo<br>one packet oral twice daily for three months | Dietary Supplement: Placebo<br>* intake Placebo twice daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Change of disease activity every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets |