Recruiting
Phase 1
Phase 2

Peppermint Oil

Sponsor:

University of Louisville

Code:

NCT04845217

Conditions

Interstitial Cystitis

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Peppermint oil

Coconut Oil

Study Details

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).

Conditions

Interstitial Cystitis

Study ID

NCT04845217

Start date

Sep 15, 2021

Status verified date

Aug, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

placebo comparator: 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).

Interventions

Peppermint oil

Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.

Coconut Oil

Enteric coated coconut oil taken by mouth three times daily for 8 weeks

Primary outcome measure

  • O'Leary/Sant questionnaire scores [ Time Frame: 8 weeks ]
  • Pelvic Pain and Urgency/Frequency questionnaire scores [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Jenna Warehime, DO

502-588-7660pepperminttrial@gmail.com

Locations

Springs Medical Center

Recruiting

Louisville, Kentucky, United States, 40205

More Information

Sponsor

University of Louisville

Last update posted

Aug 22, 2022

Last verified

Aug, 2022

Keywords

  • interstitial cystitis
  • bladder pain syndrome
  • peppermint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2022-08-22.