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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01861782
• Other study ID #: sor0356-12ctil
• Secondary ID: 0356-12-SOR
• Status: Active, not recruiting
• Phase: N/A
• First received: May 12, 2013
• Last updated: March 25, 2014
• Start date: June 2013

Study information

• Verified date: March 2014
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Dead Sea Solar and Water Treatment

• Sulfur Pool & Medicinal Mud

Locations

Country	Name	City	State
Israel	Lot Spa Hotel at the Dead Sea	Ein Bokek

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.	DAS28 will be evaluated before and immediately after the treatment, as well as one and 3 months after treatment has started	up to 4 months	No
Secondary	Assessing the change between baseline and several occasions after each one of proposed the treatments	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-a; 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	up to 4 months	No