Systemic SclerosisNCT03531216
Topical Rosemary Oil Application in Systemic Sclerosis
A study testing Rosemary essential oil in people with Systemic Sclerosis, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites in Germany.
Trial summary
The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Rosemary essential oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Nov 2015to 21 Mar 2016
- 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
- Systemic sclerosis with skin involvement of hands and fingers
- Raynaud phenomenon with frequent symptoms of cold hands
Who cannot join
- Topical treatment with nitroglyceride
- Lymphdrainage < 24 hours
- Other topical treatment of hands and arms < 4 hours prior to study intervention
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
ARCIM Institute
Filderstadt, Baden-Wurttemberg, 70794
Universitätsklinikum Tuebingen, Abteilung Innere Medizin II
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial
The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.
Read the detailed description
In a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% Rosmarinus officinalis L. (rosemary) essential oil to both hands with a wash-out period of 3 hours. Effects on vasodilatation are measured with infrared thermography. Patients' sense of warmth is assessed by the "Herdecke warmth perception questionnaire". Measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). To determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (Standardized Effect Size).
- Conditions
- Systemic Sclerosis
- Being tested
- Rosemary essential oil, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosemary essential oilOther
Topically-applied oil to both dorsal and palmar aspects of the hands
PlaceboOther
Topically-applied oil to both dorsal and palmar aspects of the hands
| Study group | Role | What they receive |
|---|---|---|
| Topical application of rosemary oil | Active comparator | Rosemary essential oil (10% ) Receives: Other: Rosemary essential oil |
| Placebo | Placebo comparator | Pharmaceutical quality olive oil Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in temperature at the fingers
Distal skin temperature in °C measured at the fingers with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application
Measured: baseline and 45 minutes after the intervention
Secondary outcomes (5)
Change from baseline in temperature at the back of the hands
Distal skin temperature in °C measured at the back of the hands with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application
Measured: baseline and 45 minutes after the intervention
Change from baseline in temperature at the forearms
Distal skin temperature in °C measured at the forearms with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application
Measured: baseline and 45 minutes after the intervention
Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)
Patients' sense of warmth in different body regions as well as overall warmth assessed before and 45 minutes following the oil application
Measured: baseline and 45 minutes after the intervention
"Scleroderma Health Assessment Questionnaire" (SHAQ)
Questionnaire with 8 sections: e.g. dressing, arising, eating, walking,hygiene, etc... with 2 or 3 questions for each section. Scoring within each section is from0 (without any difficulty) to 3 (unable to do).
Measured: baseline
Rodnan skin score of the hands
Skin score to assess the clinical severity of systemic scleroderma. 17 body areas are assessed by clinical palpation. The examiner assesses the skin thickness using a 4-point scale:0 = normal thickness, 1 = weak skin thickening, 2 = moderate skin thickening, 3 = severe skin thickening.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start2 Nov 2015
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Study director, ARCIM Institute; University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531216
- Sponsor's protocol ID
- ROS_02
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial
- ClinicalTrials.gov ID
- NCT03531216
- Acronym / sponsor ID
- ROS_02
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 21 May 2018 (actual)
- 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.
The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.
Detailed description
In a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% Rosmarinus officinalis L. (rosemary) essential oil to both hands with a wash-out period of 3 hours. Effects on vasodilatation are measured with infrared thermography. Patients' sense of warmth is assessed by the "Herdecke warmth perception questionnaire". Measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). To determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (Standardized Effect Size).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical application of rosemary oil | Active comparator | Other: Rosemary essential oilRosemary essential oil (10% ) |
| Placebo | Placebo comparator | Other: PlaceboPharmaceutical quality olive oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemic sclerosis with skin involvement of hands and fingers
- Raynaud phenomenon with frequent symptoms of cold hands
Key exclusion criteria (3 listed)
- Topical treatment with nitroglyceride
- Lymphdrainage < 24 hours
- Other topical treatment of hands and arms < 4 hours prior to study intervention
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 |
|---|---|---|
| Rosemary essential oilTopically-applied oil to both dorsal and palmar aspects of the hands | Other | Topical application of rosemary oil |
| PlaceboTopically-applied oil to both dorsal and palmar aspects of the hands | Other | Placebo |
Primary outcome
Change from baseline in temperature at the fingers
Time frame: baseline and 45 minutes after the intervention
Distal skin temperature in °C measured at the fingers with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application
5 secondary outcomes
Change from baseline in temperature at the back of the hands
Time frame: baseline and 45 minutes after the intervention
Change from baseline in temperature at the forearms
Time frame: baseline and 45 minutes after the intervention
Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)
Time frame: baseline and 45 minutes after the intervention
"Scleroderma Health Assessment Questionnaire" (SHAQ)
Time frame: baseline
Rodnan skin score of the hands
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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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.
Jan Vagedes, Dr. study director
ARCIM Institute; University of Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosemary essential oil in people with Systemic Sclerosis, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites in Germany.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in temperature at the fingers (time frame: baseline and 45 minutes after the intervention). 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 10 Jan 2019.