Effects of Open-label vs Double-blind Treatment in IBS
Overview
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Full Title of Study: “Effects of Open-label vs Double-blind Treatment in IBS.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Study Primary Completion Date: January 2019
Interventions
- Drug: placebo
- Dietary Supplement: peppermint oil
Arms, Groups and Cohorts
- Experimental: open-label placebo
- Experimental: double-blind placebo
- Experimental: double-blind peppermint oil
- No Intervention: no additional treatment
Clinical Trial Outcome Measures
Primary Measures
- Change in Irritable Bowel Syndrome – Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
- Time Frame: 6 weeks
- Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Participating in This Clinical Trial
Inclusion Criteria
- Meet Rome IV diagnostic criteria for IBS
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Collaborator
- National Center for Complementary and Integrative Health (NCCIH)
- Provider of Information About this Clinical Study
- Principal Investigator: Judy Nee, Assistant Professor of Medicine – Beth Israel Deaconess Medical Center
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