Topical Rosemary Oil Application in Systemic Sclerosis

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Other: Placebo; Other: Rosemary essential oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03531216

ROS_02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups, including a placebo group

Topical application of rosemary oil

Active Comparator group

Description:

Rosemary essential oil (10% )

Treatment:

Other: Rosemary essential oil

Placebo

Placebo Comparator group

Description:

Pharmaceutical quality olive oil

Treatment:

Other: Placebo