The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery

NCT01164644 | Completed Results

• 1 other identifier: H-2010-0065
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ecchymosis

Keywords

ecchymosis; bruising; rhinoplasty; nose job; arnica; arnica montana

Outcome Measures

Primary Outcomes (3)

• Assess Extent of Bruising

  Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.

  Post-operative day 3

• Assess Extent of Bruising

  Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.

  Post-operative day 7

• Assess Extent of Bruising

  Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.

  Post-operative day 10

Study Arms (2)

Arnica Montana

ACTIVE COMPARATOR

The subject will take twelve pills by mouth three times a day over four days.

Drug: Arnica montana

Placebo

PLACEBO COMPARATOR

The subject will take twelve pills by mouth three times a day over four days.

Drug: Placebo

Interventions

Arnica montana DRUG

Subjects will take twelve pills by mouth three times a day over four days.

Arnica Montana

Placebo DRUG

Subjects will take twelve pills by mouth three times a day over four days.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Ecchymosis; Contusions

Interventions

Arnicae flos extract; Sugars

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Scott R. Chaiet
• Organization: University of Wisconsin School of Medicine and Public Health

scottchaiet@yahoo.com

(608) 263-1092

Study Officials

• Benjamin C Marcus, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 17, 2017
• Results First Posted: May 3, 2013

Record last verified: 2017-04

Locations

US (1)