N/A
N=26
The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Ecchymosis
Bottom Line
View on ClinicalTrials.gov: NCT01164644 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
May 2013
Primary outcome: Primary: Assess Extent of Bruising — .617; .736 a ratio of pixels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arnica montana (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Extent of Bruising |
.432; .543 | — |
| PRIMARY Assess Extent of Bruising |
.432; .543 | — |
| PRIMARY Assess Extent of Bruising |
.432; .543 | — |
Summary
Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surgeons throughout the world, although there is no study proving its benefit after rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the amount of bruising and the intensity of the bruising after surgery. Photographs of the subject's face will be taken and used to analyze bruising after rhinoplasty surgery in subjects who receive Arnica montana and compare them to photographs of subjects who take a placebo (sugar pill).
Eligibility Criteria
Inclusion Criteria: Adult patients who are deemed candidates for rhinoplasty surgery at UW Transformations will be eligible to participate in the study.
-
Exclusion Criteria
- Patients who are prisoners
- Patients who are pregnant and breast-feeding women
- Patients taking anti-coagulants (such as blood thinners), anti-platelet drugs (such as NSAIDS), or other homeopathic remedies during the peri-operative period
- Patients with a bruising or bleeding disorder
- Patients who take oral corticosteroid therapy
- Patients who suffer from severe liver or kidney disease
- Patients with malignancy, infection, immunodeficiency, metabolic syndrome, infectious or inflammatory gastrointestinal disease
- Patients with oral or contact allergies to Arnica montana or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies
Data sourced from ClinicalTrials.gov (NCT01164644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.