Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pelvic Pain and Urgency/Frequency questionnaire scores
研究概览
简要总结
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
详细描述
After being informed about the study and potential risks, all participants will complete validated IC/BPS symptom questionnaires for baseline screening. Once participants meet eligibility requirements and give written informed consent they will be randomized in a 1:1 ratio to peppermint oil (200mg TID) or placebo (also TID). Participants will complete validated IC/BPS questionnaires and follow up surveys over 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The peppermint-oil and placebo treatments will be kept in a locked and secured area of the office, in a room not used for patient care. The bottles will be de-identified, with labels detailing the specific instructions for how to take the soft gels and the number in each bottle. Each group will be instructed to take one soft gel three times daily.
The peppermint oil and placebo medications will be distributed by the research team. The manufacturer label will be covered up/removed and a study label stating the use of a study medication will be used to maintain patient blinding.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 18-65 years old
- •Diagnosed with IC/BPS for at least one month prior to study enrollment
排除标准
- •Culture proven urinary tract infection within 1 month of randomization
- •Gross hematuria
- •Currently pregnant or breastfeeding
- •Unable to speak and read English
- •History of allergic reaction to peppermint, coconut or enteric coating
- •History of malabsorption syndrome
- •History of gastroparesis
- •History of gastric bypass surgery
- •History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years
- •History of insulin dependent diabetes
- •History of active urinary stone disease
研究组 & 干预措施
Peppermint Oil
Participants in the intervention (peppermint oil) arm will receive soft gels of enteric-coated peppermint oil (0.2mL=200mg). The enteric coated peppermint oil soft gel utilized in this study is Peptogest Peppermint Oil from Schwabe North America (Nature's Way Brand).
干预措施: Peppermint oil (Drug)
Coconut Oil
Participants in the placebo (coconut oil) arm will receive soft gels of enteric coated coconut oil. The enteric coated coconut oil soft gel utilized in this study is Coconut Oil from Schwabe North America (Nature's Way Brand).
干预措施: Coconut Oil (Drug)
结局指标
主要结局
Pelvic Pain and Urgency/Frequency questionnaire scores
时间窗: 8 weeks
Participant responses to the Pelvic Pain and Urgency/Frequency questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
O'Leary/Sant questionnaire scores
时间窗: 8 weeks
Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
次要结局
- Urine pH(8 weeks)
- Incidence of urinary tract infections (UTIs)(8 weeks)
- Additional IC/BPS Treatments received(8 weeks)
研究者
Sean Francis, MD
Professor, MD
University of Louisville