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NCT02802241 Clinical Trial

Effects of Open-label vs Double-blind Treatment in IBS

Irritable Bowel Syndrome Clinical Trial

Official title:
Effects of Open-label vs Double-blind Treatment in IBS.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02802241
Other study ID # 2015P000282
Secondary ID R01AT008573
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date January 2019

Study information
Verified date January 2024
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 340
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Meet Rome IV diagnostic criteria for IBS

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• placebo

Dietary Supplement:
• peppermint oil

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms 6 weeks
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