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

March 25, 2014 updated by: Mahmoud Abu-Shakra, Soroka University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ein Bokek, Israel
        • Lot Spa Hotel at the Dead Sea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
Time Frame: 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
up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the change between baseline and several occasions after each one of proposed the treatments
Time Frame: 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
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 12, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor0356-12ctil
  • 0356-12-SOR (Other Identifier: Soroka University Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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