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

Soroka University Medical Center

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Other: Sulfur Pool & Medicinal Mud; Other: Dead Sea Solar and Water Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01861782

0356-12-SOR (Other Identifier)

sor0356-12ctil

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dead Sea Solar and Water Treatment

Experimental group

Description:

Dead Sea Solar and Water Treatment

Treatment:

Other: Dead Sea Solar and Water Treatment

Sulfur Pool & Medicinal Mud

Experimental group

Description:

Sulfur Pool \& Medicinal Mud

Treatment:

Other: Sulfur Pool & Medicinal Mud