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| Name | Class |
|---|---|
| Integrative Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peppermint Oil | Experimental | 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). |
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| Coconut Oil | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peppermint oil | Drug | Enteric coated peppermint oil taken by mouth three times daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urine pH | Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period | 8 weeks |
| Incidence of urinary tract infections (UTIs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Warehime, DO | Contact | 502-588-7660 | pepperminttrial@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Francis, MD | Department Chair | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Springs Medical Center | Recruiting | Louisville | Kentucky | 40205 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 19, 2024 | Aug 12, 2024 | 5 | ||
| Sep 23, 2024 |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C015424 | peppermint oil |
| D000074263 | Coconut Oil |
| ID | Term |
|---|---|
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 |
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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.
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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.
| Coconut Oil | Drug | Enteric coated coconut oil taken by mouth three times daily for 8 weeks |
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Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)
| 8 weeks |
| Additional IC/BPS Treatments received | Number and type of additional IC/BPS each participant undergoes | 8 weeks |
| Oct 14, 2024 |
| 6 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Oils |