Interstitial CystitisPhase 1/2NCT04845217
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
A Phase 1/2 study testing Peppermint oil and Coconut Oil in people with Interstitial Cystitis, run by University of Louisville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Peppermint oil and Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to Dec 2023
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ages 18-65 years old
- Diagnosed with IC/BPS for at least one month prior to study enrollment
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Springs Medical Center
Louisville, Kentucky, 40205
Sean Francis, MD
About this study
Official title: Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
Read the detailed 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.
- Conditions
- Interstitial Cystitis
- Being tested
- Peppermint oil, Coconut Oil
- Keywords
- interstitial cystitis, bladder pain syndrome, peppermint
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint oilDrug
Also called Peptogest Peppermint Oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Coconut OilDrug
Also called Coconut Oil Pure Extra Virgin
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Peppermint oil |
| 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). Receives: Drug: Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (3)
Urine pH
Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period
Measured: 8 weeks
Incidence of urinary tract infections (UTIs)
Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)
Measured: 8 weeks
Additional IC/BPS Treatments received
Number and type of additional IC/BPS each participant undergoes
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start15 Sep 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Integrative Therapeutics, Inc.
- Responsible party
- Principal investigator, Sean Francis, MD, University of Louisville
- Investigators
- Sean Francis, MD, Principal investigator, Department Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845217
- Sponsor's protocol ID
- 21.0286
- Status last verified
- Aug 2022
- First submitted
- 29 Mar 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT04845217
- Acronym / sponsor ID
- 21.0286
- Conditions
- Interstitial Cystitis
- Keywords
- interstitial cystitis, bladder pain syndrome, peppermint
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Integrative Therapeutics, Inc.
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil | Experimental | Drug: Peppermint oilParticipants 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). |
| Coconut Oil | Placebo comparator | Drug: Coconut OilParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women ages 18-65 years old
- Diagnosed with IC/BPS for at least one month prior to study enrollment
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peppermint oilAlso: Peptogest Peppermint OilEnteric coated peppermint oil taken by mouth three times daily for 8 weeks. | Drug | Peppermint Oil |
| Coconut OilAlso: Coconut Oil Pure Extra VirginEnteric coated coconut oil taken by mouth three times daily for 8 weeks | Drug | Coconut Oil |
Primary outcome
O'Leary/Sant questionnaire scores
Time frame: 8 weeks
Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
Pelvic Pain and Urgency/Frequency questionnaire scores
Time frame: 8 weeks
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.
3 secondary outcomes
Urine pH
Time frame: 8 weeks
Incidence of urinary tract infections (UTIs)
Time frame: 8 weeks
Additional IC/BPS Treatments received
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Francis, MD principal investigator
Department Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peppermint oil and Coconut Oil in people with Interstitial Cystitis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Warehime, DO (502-588-7660, pepperminttrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O'Leary/Sant questionnaire scores (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.