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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT008573 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label placebo | Experimental |
| |
| double-blind placebo | Experimental |
| |
| double-blind peppermint oil | Experimental |
| |
| no additional treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug |
| ||
| peppermint oil |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33605656 | Derived | Lembo A, Kelley JM, Nee J, Ballou S, Iturrino J, Cheng V, Rangan V, Katon J, Hirsch W, Kirsch I, Hall K, Davis RB, Kaptchuk TJ. Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial. Pain. 2021 Sep 1;162(9):2428-2435. doi: 10.1097/j.pain.0000000000002234. | |
| 28545508 | Derived | Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Placebo | placebo |
| FG001 | Double-blind Placebo | placebo |
| FG002 | Double-blind Peppermint Oil | peppermint oil |
| FG003 | no Pill Control | control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention to treat. Double-blind peppermint oil was not collected in the intention to treat.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Placebo | placebo |
| BG001 | Double-blind Placebo | placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Double-blind peppermint oil data was not part of the planned analysis. While the data was collected, the results were analyzed with a modified intention to treat which differs from the primary analysis of intention to treat. The outcome results data are not an accurate comparision. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 weeks |
|
6 weeks
Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Placebo | placebo | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Nee | BIDMC | 6176672193 | jnee@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2018 | Jul 20, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2018 | Jul 20, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C015424 | peppermint oil |
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| Dietary Supplement |
|
| no Pill Control |
control |
| BG003 | Double-blind Peppermint Oil | peppermint oil |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| IBS-SSS | Mean | Standard Deviation | units on a scale |
|
| OG002 | no Pill Control | control |
| OG003 | Double-blind Peppermint Oil | peppermint oil |
|
|
| 96 |
| 0 |
| 96 |
| 5 |
| 96 |
| EG001 | Double-blind Placebo | placebo | 0 | 97 | 0 | 97 | 11 | 97 |
| EG002 | Double-blind Peppermint Oil | peppermint oil | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | no Pill Control | control | 0 | 98 | 0 | 98 | 0 | 98 |
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D004066 | Digestive System Diseases |