Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

Interstitial Cystitis Clinical Trial

Official title:

Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845217
• Other study ID #: 21.0286
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University of Louisville
• Contact: Jenna Warehime, DO
• Phone: 502-588-7660
• Email: pepperminttrial[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women ages 18-65 years old

• Diagnosed with IC/BPS for at least one month prior to study enrollment

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Springs Medical Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Integrative Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Incidence of urinary tract infections (UTIs)	Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)	8 weeks
Secondary	Additional IC/BPS Treatments received	Number and type of additional IC/BPS each participant undergoes	8 weeks