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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT04845217
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Interstitial Cystitis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Peppermint oil — DRUG
    Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
  • Coconut Oil — DRUG
    Enteric coated coconut oil taken by mouth three times daily for 8 weeks

Study Details

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

Key Dates

Start date
Sep 15, 2021
Status verified
Aug 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

O'Leary/Sant questionnaire scores [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Springs Medical CenterLouisvilleKentucky40205
Sean Francis, MD

Find similar trials in Louisville, KY

By research site
Springs Medical Center· Louisville, KY

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