NCT04845217PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

University of Louisville

Start Date

9/15/2021

Completion Date

12/1/2023

Summary

The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Women ages 18-65 years old * Diagnosed with IC/BPS for at least one month prior to study enrollment Exclusion Criteria: * 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

Interventions

DRUG

Peppermint oil

DRUG

Coconut Oil

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Conditions

Interstitial Cystitis

Locations

Springs Medical Center

Louisville, Kentucky 40205

United States