A Phase 1/2 interventional study of Peppermint oil and Coconut Oil in Interstitial Cystitis, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by University of Louisville · Phase 1/2, Interventional, and Treatment
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 100 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 peppermint oil taken by mouth three times daily for 8 weeks.
Also known as: Peptogest Peppermint Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Also known as: Coconut Oil Pure Extra Virgin
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Urine pH
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
Incidence of urinary tract infections (UTIs)
Culture proven UTIs during the study period (\>100,000 CFU of a single pathogen)
Time frame: 8 weeks
Additional IC/BPS Treatments received
Number and type of additional IC/BPS each participant undergoes
Time frame: 8 weeks
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Studies of the drug tested here: Peppermint oil