NCT04845217 Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
| NCT ID | NCT04845217 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Louisville |
| Condition | Interstitial Cystitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2023-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2021-09-15 with a primary completion date of 2023-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Sean Francis, MD
PRINCIPAL INVESTIGATOR
Department Chair
Frequently Asked Questions
Who can join the NCT04845217 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Interstitial Cystitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04845217 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04845217 currently recruiting?
Yes, NCT04845217 is actively recruiting participants. Contact the research team at pepperminttrial@gmail.com for enrollment information.
Where is the NCT04845217 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT04845217 clinical trial?
NCT04845217 is sponsored by University of Louisville. The principal investigator is Sean Francis, MD at Department Chair. The trial plans to enroll 100 participants.