Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Dead Sea Solar and Water Treatment
* Other: Sulfur Pool & Medicinal Mud


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female ≥ 18 Patients with diagnosed rheumatoid arthritis Patients with moderate disease activity (DAS28 > 3.2) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dead Sea Solar and Water Treatment<br>Dead Sea Solar and Water Treatment | Other: Dead Sea Solar and Water Treatment<br> <br> |
| Experimental: Sulfur Pool & Medicinal Mud<br>Sulfur Pool & Medicinal Mud | Other: Sulfur Pool & Medicinal Mud<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments. | DAS28 will be evaluated before and immediately after the treatment, as well as one and 3 months after treatment has started | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the change between baseline and several occasions after each one of proposed the treatments | Composite outcome measure : Assessing the change between baseline and several occasions after each one of proposed the treatments by the following parameters: CRP ESR Vitamine D 25 (OH) TNF-α Cytokines (IL1, IL6, IL10, IL17, IL23) The various markers levels will be obtained from serum samples collected before and right after treatment, one month after treatment and 3 months after treatment has started using ELISA method | up to 4 months |