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

University of Louisville (UOFL)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Interstitial Cystitis

Treatments: Drug: Peppermint oil; Drug: Coconut Oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04845217

21.0286

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Peppermint Oil

Experimental group

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).

Treatment:

Drug: Peppermint oil

Coconut Oil

Placebo Comparator group

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).

Treatment:

Drug: Coconut Oil