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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. completion date
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


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
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