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

Primary Purpose

Interstitial Cystitis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil
Coconut Oil
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring interstitial cystitis, bladder pain syndrome, peppermint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Springs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peppermint Oil

Coconut Oil

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2021
Last Updated
August 19, 2022
Sponsor
University of Louisville
Collaborators
Integrative Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04845217
Brief Title
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
Official Title
Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Integrative Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
interstitial cystitis, bladder pain syndrome, peppermint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 1:1 ratio to the intervention or placebo arm. Allocation concealment will be in place to ensure the individual enrolling the subject into the study has no a priori knowledge of group assignment. Block randomization will occur with randomly mixed block sizes of 4, 6, and 8 using the randomization list generator at www.sealedenvelope.com. Randomization information will be kept confidential and only available to study personnel.
Masking
Participant
Masking Description
The peppermint-oil and placebo treatments will be kept in a locked and secured area of the office, in a room not used for patient care. The bottles will be de-identified, with labels detailing the specific instructions for how to take the soft gels and the number in each bottle. Each group will be instructed to take one soft gel three times daily. The peppermint oil and placebo medications will be distributed by the research team. The manufacturer label will be covered up/removed and a study label stating the use of a study medication will be used to maintain patient blinding.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peppermint Oil
Arm Type
Experimental
Arm Description
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).
Arm Title
Coconut Oil
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Peppermint oil
Other Intervention Name(s)
Peptogest Peppermint Oil
Intervention Description
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Coconut Oil
Other Intervention Name(s)
Coconut Oil Pure Extra Virgin
Intervention Description
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Primary Outcome Measure Information:
Title
O'Leary/Sant questionnaire scores
Description
Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
Time Frame
8 weeks
Title
Pelvic Pain and Urgency/Frequency questionnaire scores
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Urine pH
Description
Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period
Time Frame
8 weeks
Title
Incidence of urinary tract infections (UTIs)
Description
Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)
Time Frame
8 weeks
Title
Additional IC/BPS Treatments received
Description
Number and type of additional IC/BPS each participant undergoes
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Warehime, DO
Phone
502-588-7660
Email
pepperminttrial@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Francis, MD
Organizational Affiliation
Department Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
Springs Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Francis, MD

12. IPD Sharing Statement

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

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