A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
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ClinicalTrials.gov Identifier: NCT00587860 |
Recruitment Status
:
Completed
First Posted
: January 8, 2008
Results First Posted
: March 1, 2010
Last Update Posted
: March 9, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | December 27, 2007 | |||
First Posted Date ICMJE | January 8, 2008 | |||
Results First Submitted Date | October 26, 2009 | |||
Results First Posted Date | March 1, 2010 | |||
Last Update Posted Date | March 9, 2010 | |||
Study Start Date ICMJE | February 2006 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Bowel Symptom Scores (BSS) [ Time Frame: After 12 weeks of treatment ] The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain. |
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Original Primary Outcome Measures ICMJE |
Self-reported overall Bowel Symptom Scores (BSS) after 12 weeks of treatment will be used as the primary endpoint in this study [ Time Frame: After 12 weeks of treatment ] | |||
Change History | Complete list of historical versions of study NCT00587860 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome | |||
Official Title ICMJE | A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome | |||
Brief Summary | This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. | |||
Detailed Description | Eligibility criteria:
4) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study You will be asked to do the following:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Irritable Bowel Syndrome | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
70 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00587860 | |||
Other Study ID Numbers ICMJE | 132-06 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Yuri A. Saito Loftus, M.D., Mayo Clinic | |||
Study Sponsor ICMJE | Mayo Clinic | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |