Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
研究概览
简要总结
Prospective open label crossover self controlled study. The study population will randomly be divided into two groups.
The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16 participants and one of 14 participants) and will be comprised of 3 main stages:
- Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol)
- 12-month washout period
- Crossover of the two groups and second exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol).
The population in the study will be composed of patients diagnosed and treated for rheumatoid arthritis at the Soroka University Medical Center who are 18 and above of age.
The patients will be selected by the PI and his team and addressed regarding their willingness to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥ 18
- •Patients with diagnosed rheumatoid arthritis
- •Patients with moderate disease activity (DAS28 > 3.2)
排除标准
- •Patients who suffer from Photosensitivity
- •Patients with Suspected Lupus Erythematoides
- •Patients with tendency to sudden loss of consciousness and/or dizziness
- •Patients under chemotherapeutic treatment
- •Patients with Active Malignancy
- •Patients with lowest level of physical functioning (class 4)
- •Patients with serious uncontrolled concomitant chronic disease
- •Drug Abuser
- •Patients with severe peripheral venous insufficiency
- •Pregnant women
结局指标
主要结局
Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
时间窗: up to 4 months
DAS28 will be evaluated before and immediately after the treatment, as well as one and 3 months after treatment has started
次要结局
- Assessing the change between baseline and several occasions after each one of proposed the treatments(up to 4 months)
研究者
Mahmoud Abu-Shakra
Head of Rheumatology Clinic
Soroka University Medical Center