NCT01295268终止不适用
The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The change in the Global Response Assessment (GRA) for vulvar pain.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with vulvar pain upon q-tip exam of > 3/10 at 2 or more sites tested.
- •Age 18 or older.
- •Capable of giving informed consent.
- •Capable and willing to follow all study procedures.
排除标准
- •Pregnant women or those intending to become pregnant during the study period.
- •Vaginitis (may be treated, then tested later).
- •Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation.
- •The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
- •Neuropathy.
- •Currently in pelvic floor physical therapy.
研究组 & 干预措施
Emu Oil
Active Comparator
干预措施: Emu Oil (Other)
inert oil
Placebo Comparator
干预措施: Inert oil (Other)
结局指标
主要结局
The change in the Global Response Assessment (GRA) for vulvar pain.
时间窗: After 1 month of intervention
Those "moderately" or "markedly" improved on the GRA are responders
次要结局
- The change in vulvar pain levels(After 1 month of intervention)
研究者
研究点 (1)
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