Status:
RECRUITING
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Integrative Therapeutics, Inc.
Conditions:
Interstitial Cystitis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Women ages 18-65 years old
- Diagnosed with IC/BPS for at least one month prior to study enrollment
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04845217
Start Date
September 15 2021
End Date
December 1 2023
Last Update
August 22 2022
Active Locations (1)
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1
Springs Medical Center
Louisville, Kentucky, United States, 40205