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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •active infection or chronic infection
- •uncontrolled disease status of inflammatory arthritis
- •unwilling to take herbal tea
- •with difficulty for return visits
结局指标
主要结局
Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]
时间窗: Change of fatigue level every 4 weeks until 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)
次要结局
- Change in disease activity of inflammatory arthritis [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets](Change of disease activity every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets)
