Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
NCT ID: NCT04845217
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2021-09-15
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
NCT02457182
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
NCT06096597
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
NCT04349930
Hypnosis for Bladder Pain Syndrome
NCT04010513
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
NCT01731470
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peppermint Oil
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).
Peppermint oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Coconut 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).
Coconut Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peppermint oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Coconut Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with IC/BPS for at least one month prior to study enrollment
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Integrative Therapeutics, Inc.
INDUSTRY
University of Louisville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sean Francis, MD
Professor, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sean Francis, MD
Role: PRINCIPAL_INVESTIGATOR
Department Chair
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Springs Medical Center
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sean Francis, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21.0286
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.