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

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01861782
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: Dead Sea Solar and Water Treatment; Other: Sulfur Pool & Medicinal Mud	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lot Spa Hotel at the Dead Sea	Ein Bokek		Israel

Sponsors and Collaborators

• Soroka University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Abu-Shakra, Head of Rheumatology Clinic, Soroka University Medical Center
• ClinicalTrials.gov Identifier: NCT01861782
• Other Study ID Numbers: sor0356-12ctil; 0356-12-SOR
• First Posted: May 24, 2013
• Last Update Posted: Mar 26, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Mar 26, 2014