Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits.
A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.|
- The change in the Global Response Assessment (GRA) for vulvar pain. [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]Those "moderately" or "markedly" improved on the GRA are responders
- The change in vulvar pain levels [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
|Study Start Date:||February 2011|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Emu Oil||
Other: Emu Oil
Subjects will apply a specified amount of emu oil daily to area.
|Placebo Comparator: inert oil||
Other: Inert oil
A specified amount of inert oil will be applied daily to area.
- Women of all ages with vulvar pain may participate in this trial.
- Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study.
- At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.
|United States, Michigan|
|Beaumont Women's Urology Center|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Donna J Carrico, WHNP, MS||William Beaumont Hospitals|