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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2023
  • participants needed
    100
  • sponsor
    University of Louisville
Updated on 4 October 2022
bladder pain
pain disorders
Accepts healthy volunteers

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).

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.

Details
Condition Interstitial Cystitis
Treatment Coconut Oil, peppermint oil
Clinical Study IdentifierNCT04845217
SponsorUniversity of Louisville
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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