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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dead Sea Solar and Water Treatment
Sulfur Pool & Medicinal Mud
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lot Spa Hotel at the Dead Sea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dead Sea Solar and Water Treatment

Sulfur Pool & Medicinal Mud

Arm Description

Dead Sea Solar and Water Treatment

Sulfur Pool & Medicinal Mud

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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-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

Full Information

First Posted
May 12, 2013
Last Updated
March 25, 2014
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01861782
Brief Title
Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA
Official Title
Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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: Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol) 12-month washout period 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dead Sea Solar and Water Treatment
Arm Type
Experimental
Arm Description
Dead Sea Solar and Water Treatment
Arm Title
Sulfur Pool & Medicinal Mud
Arm Type
Experimental
Arm Description
Sulfur Pool & Medicinal Mud
Intervention Type
Other
Intervention Name(s)
Dead Sea Solar and Water Treatment
Intervention Type
Other
Intervention Name(s)
Sulfur Pool & Medicinal Mud
Primary Outcome Measure Information:
Title
Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
Description
DAS28 will be evaluated before and immediately after the treatment, as well as one and 3 months after treatment has started
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
Assessing the change between baseline and several occasions after each one of proposed the treatments
Description
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
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female ≥ 18 Patients with diagnosed rheumatoid arthritis Patients with moderate disease activity (DAS28 > 3.2) Exclusion Criteria: Patients who suffer from Photosensitivity Patients with Suspected Lupus Erythematoides Patients with tendency to sudden loss of consciousness and/or dizziness Patients under chemotherapeutic treatment Patients with Active Malignancy Patients with lowest level of physical functioning (class 4) Patients with serious uncontrolled concomitant chronic disease Drug Abuser Patients with severe peripheral venous insufficiency Pregnant women
Facility Information:
Facility Name
Lot Spa Hotel at the Dead Sea
City
Ein Bokek
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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