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

August 19, 2022 updated by: Sean Francis, MD, University of Louisville

Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Springs Medical Center
        • Contact:
          • Sean Francis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Drug: Peppermint oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Other Names:
  • Peptogest Peppermint Oil
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).
Drug: Coconut Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Other Names:
  • Coconut Oil Pure Extra Virgin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
O'Leary/Sant questionnaire scores
Time Frame: 8 weeks
Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
8 weeks
Pelvic Pain and Urgency/Frequency questionnaire scores
Time Frame: 8 weeks
Participant responses to the Pelvic Pain and Urgency/Frequency questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine pH
Time Frame: 8 weeks
Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period
8 weeks
Incidence of urinary tract infections (UTIs)
Time Frame: 8 weeks
Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)
8 weeks
Additional IC/BPS Treatments received
Time Frame: 8 weeks
Number and type of additional IC/BPS each participant undergoes
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Integrative Therapeutics, Inc.

Investigators

  • Principal Investigator: Sean Francis, MD, Department Chair

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.0286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Interstitial Cystitis

Clinical Trials on Peppermint oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe