Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03531216 |
Date of registration:
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09/05/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Topical Rosemary Oil Application in Systemic Sclerosis
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Scientific title:
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Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial |
Date of first enrolment:
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November 2, 2015 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03531216 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Jan Vagedes, Dr. |
Address:
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Telephone:
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Email:
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Affiliation:
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ARCIM Institute; University of Tuebingen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Systemic sclerosis with skin involvement of hands and fingers
- Raynaud phenomenon with frequent symptoms of cold hands
Exclusion Criteria:
- Topical treatment with nitroglyceride
- Lymphdrainage < 24 hours
- Other topical treatment of hands and arms < 4 hours prior to study intervention
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Other: Placebo
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Other: Rosemary essential oil
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Primary Outcome(s)
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Change from baseline in temperature at the fingers
[Time Frame: baseline and 45 minutes after the intervention]
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Secondary Outcome(s)
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"Scleroderma Health Assessment Questionnaire" (SHAQ)
[Time Frame: baseline]
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Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)
[Time Frame: baseline and 45 minutes after the intervention]
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Rodnan skin score of the hands
[Time Frame: baseline]
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Change from baseline in temperature at the forearms
[Time Frame: baseline and 45 minutes after the intervention]
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Change from baseline in temperature at the back of the hands
[Time Frame: baseline and 45 minutes after the intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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