Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA
2 other identifiers
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedMarch 26, 2014
March 1, 2014
2 years
May 12, 2013
March 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Assessing the change between baseline and several occasions after each one of proposed the treatments
up to 4 months
Study Arms (2)
Dead Sea Solar and Water Treatment
EXPERIMENTALDead Sea Solar and Water Treatment
Sulfur Pool & Medicinal Mud
EXPERIMENTALSulfur Pool \& Medicinal Mud
Interventions
Eligibility Criteria
You may qualify if:
- Male and female ≥ 18
- Patients with diagnosed rheumatoid arthritis
- Patients with moderate disease activity (DAS28 \> 3.2)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lot Spa Hotel at the Dead Sea
Ein Bokek, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Rheumatology Clinic
Study Record Dates
First Submitted
May 12, 2013
First Posted
May 24, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Last Updated
March 26, 2014
Record last verified: 2014-03