Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA
This trial is active, not recruiting.
|Treatments||dead sea solar and water treatment, sulfur pool & medicinal mud|
|Sponsor||Soroka University Medical Center|
|Start date||June 2013|
|End date||June 2015|
|Trial size||30 participants|
|Trial identifier||NCT01861782, 0356-12-SOR, sor0356-12ctil|
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:
1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol)
2. 12-month washout period
3. 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.
|Intervention model||crossover assignment|
|Primary purpose||supportive care|
Dead Sea Solar and Water Treatment
Sulfur Pool & Medicinal Mud
Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
time frame: up to 4 months
Assessing the change between baseline and several occasions after each one of proposed the treatments
time frame: up to 4 months
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Male and female ≥ 18 2. Patients with diagnosed rheumatoid arthritis 3. Patients with moderate disease activity (DAS28 > 3.2) Exclusion Criteria: 1. Patients who suffer from Photosensitivity 2. Patients with Suspected Lupus Erythematoides 3. Patients with tendency to sudden loss of consciousness and/or dizziness 4. Patients under chemotherapeutic treatment 5. Patients with Active Malignancy 6. Patients with lowest level of physical functioning (class 4) 7. Patients with serious uncontrolled concomitant chronic disease 8. Drug Abuser 9. Patients with severe peripheral venous insufficiency 10. Pregnant women
|Official title||Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis|
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