Actively Recruiting
Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
Led by University of Louisville · Updated on 2022-08-22
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
I
Integrative Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) in women. This randomized, single-blind, placebo-controlled trial aims to assess symptom improvements and urinary outcomes over an 8-week period. The study is sponsored by the University of Louisville and focuses on adult women diagnosed with IC/BPS for at least one month. Participants will be randomly assigned to one of two groups: one receiving enteric-coated peppermint oil soft gels (200mg) three times daily and the other receiving enteric-coated coconut oil placebo soft gels with the same dosing schedule. Both treatments will be taken by mouth over the course of 8 weeks. The peppermint oil used is Peptogest Peppermint Oil, and the placebo is a coconut oil soft gel, both from Schwabe North America. During the study, participants will complete validated IC/BPS symptom questionnaires, including the O'Leary/Sant and Pelvic Pain and Urgency/Frequency questionnaires, at baseline and throughout the 8 weeks. Researchers will also monitor urine pH, incidence of urinary tract infections, and any additional IC/BPS treatments received. Study visits include baseline screening, randomization, and follow-up surveys to assess symptom changes and safety throughout the treatment period.
CONDITIONS
Brief Title
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women ages 18-65 years old
- Diagnosed with Interstitial Cystitis/Bladder Pain Syndrome for at least one month prior to study enrollment
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants take enteric coated peppermint oil or placebo soft gels by mouth three times daily.
Participants complete questionnaires and follow-up surveys during this period.
Trial Site Locations
Total: 1 location
1
Springs Medical Center
Louisville, Kentucky, United States, 40205
Actively Recruiting
Research Team
J
Jenna Warehime, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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