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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03531216
Other study ID # ROS_02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2015
Est. completion date March 21, 2016

Study information

Verified date May 2018
Source ARCIM Institute Academic Research in Complementary and Integrative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 21, 2016
Est. primary completion date March 21, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Rosemary essential oil
Topically-applied oil to both dorsal and palmar aspects of the hands
Placebo
Topically-applied oil to both dorsal and palmar aspects of the hands

Locations

Country Name City State
Germany ARCIM Institute Filderstadt Baden Württemberg
Germany Universitätsklinikum Tuebingen, Abteilung Innere Medizin II Tuebingen Baden-Württemberg

Sponsors (2)

Lead Sponsor Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline and 45 minutes after the intervention
Secondary 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 baseline and 45 minutes after the intervention
Secondary 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 baseline and 45 minutes after the intervention
Secondary 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 baseline and 45 minutes after the intervention
Secondary "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). baseline
Secondary 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. baseline
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