Rheumatoid ArthritisNCT01861782
Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA
A study testing Dead Sea Solar and Water Treatment and Sulfur Pool & Medicinal Mud in people with Rheumatoid Arthritis, run by Soroka University Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Dead Sea Solar and Water Treatment and Sulfur Pool & Medicinal Mud
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female ≥ 18
- Patients with diagnosed rheumatoid arthritis
- Patients with moderate disease activity (DAS28 > 3.2)
Who cannot join
- 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)
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- Patients with serious uncontrolled concomitant chronic disease
- Drug Abuser
- Patients with severe peripheral venous insufficiency
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Dead Sea Solar and Water Treatment, Sulfur Pool & Medicinal Mud
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dead Sea Solar and Water TreatmentOther
Sulfur Pool & Medicinal MudOther
| Study group | Role | What they receive |
|---|---|---|
| Dead Sea Solar and Water Treatment | Experimental | Dead Sea Solar and Water Treatment Receives: Other: Dead Sea Solar and Water Treatment |
| Sulfur Pool & Medicinal Mud | Experimental | Sulfur Pool \& Medicinal Mud Receives: Other: Sulfur Pool & Medicinal Mud |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 months
Secondary outcomes (1)
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
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abu-Shakra, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861782
- Sponsor's protocol ID
- sor0356-12ctil
- Other IDs
- 0356-12-SOR
- Status last verified
- Mar 2014
- First submitted
- 12 May 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01861782
- Acronym / sponsor ID
- sor0356-12ctil
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dead Sea Solar and Water Treatment | Experimental | Other: Dead Sea Solar and Water TreatmentDead Sea Solar and Water Treatment |
| Sulfur Pool & Medicinal Mud | Experimental | Other: Sulfur Pool & Medicinal MudSulfur Pool \& Medicinal Mud |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female ≥ 18
- Patients with diagnosed rheumatoid arthritis
- Patients with moderate disease activity (DAS28 > 3.2)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dead Sea Solar and Water Treatment | Other | Dead Sea Solar and Water Treatment |
| Sulfur Pool & Medicinal Mud | Other | Sulfur Pool & Medicinal Mud |
Primary outcome
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
1 secondary outcome
Assessing the change between baseline and several occasions after each one of proposed the treatments
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dead Sea Solar and Water Treatment and Sulfur Pool & Medicinal Mud in people with Rheumatoid Arthritis, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.