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OpenTrials
Completed

NCT Number: NCT02802241

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

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Peppermint Oil Placebo Effect Placebos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet Rome IV diagnostic criteria for IBS

Treatment and study plan

Placebo

Drug

peppermint oil

Dietary Supplement

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2016
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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