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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Dead Sea Solar and Water Treatment; Other: Sulfur Pool & Medicinal Mud

• Registration Number: NCT01861782
• Lead Sponsor: Soroka University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Study Start: 2013-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dead Sea Solar and Water Treatment	Dead Sea Solar and Water Treatment	Dead Sea Solar and Water Treatment
Sulfur Pool & Medicinal Mud	Sulfur Pool & Medicinal Mud	Sulfur Pool \& Medicinal Mud

Primary Outcome Measures

Name	Time	Method
Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.	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

Secondary Outcome Measures

Name	Time	Method
Assessing the change between baseline and several occasions after each one of proposed the treatments	up to 4 months	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

Trial Locations

Locations (1)

Lot Spa Hotel at the Dead Sea; 🇮🇱 Ein Bokek, Israel