Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Dead Sea Solar and Water Treatment
dead sea solar and water treatment
(Experimental)
Sulfur Pool & Medicinal Mud
sulfur pool & medicinal mud

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Assessing the change between baseline and several occasions after each one of proposed the treatments
time frame: up to 4 months

Eligibility Criteria

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

Additional Information

Official title Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Soroka University Medical Center.