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Essential Oil
Peppermint Oil for Interstitial Cystitis
Phase 1 & 2
Recruiting
Led By Sean Francis, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial will study whether peppermint oil can help treat IC/BPS.
Eligible Conditions
- Painful Bladder Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
O'Leary/Sant questionnaire scores
Pelvic Pain and Urgency/Frequency questionnaire scores
Secondary study objectives
Additional IC/BPS Treatments received
Incidence of urinary tract infections (UTIs)
Urine pH
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Peppermint OilExperimental Treatment1 Intervention
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).
Group II: Coconut OilPlacebo Group1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peppermint oil
FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of LouisvilleLead Sponsor
346 Previous Clinical Trials
77,465 Total Patients Enrolled
Integrative Therapeutics, Inc.Industry Sponsor
1 Previous Clinical Trials
257 Total Patients Enrolled
Sean Francis, MDPrincipal InvestigatorDepartment Chair
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a condition that makes it hard for your body to absorb nutrients from food.You have a history of gastroparesis, which is a condition that affects stomach emptying.You had cancer in your stomach, intestines, urinary system, or pelvic area in the last 5 years.You have been diagnosed with IC/BPS for at least one month before joining the study.You have been diagnosed with a urinary tract infection confirmed by a laboratory test within the past month.You have visible blood in your urine.You have had surgery to reduce the size of your stomach.You have had problems with kidney stones in the past.Women between 18 and 65 years old.You have had an allergic reaction to peppermint, coconut, or enteric coating in the past.You need to take insulin for your diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Peppermint Oil
- Group 2: Coconut Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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