Aloe Vera in Irritable Bowel Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Sahlgrenska University Hospital, Sweden.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sahlgrenska University Hospital, Sweden
Collaborator:
Aloe Scandinavia AB
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01400048
First received: July 19, 2011
Last updated: July 21, 2011
Last verified: January 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 19, 2011 | ||||||||
| Last Updated Date | July 21, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
IBS symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01400048 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aloe Vera in Irritable Bowel Syndrome | ||||||||
| Official Title ICMJE | Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome | ||||||||
| Brief Summary | The purpose of the present study is to study the effect of aloe vera in the treatment of IBS patients in a randomized, double-blind placebo controlled study. |
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| Detailed Description | There is limited knowledge of the IBS pathophysiology, absence of biological markers and therefore few effective treatment options. IBS therefor contributes to difficulties in the management of the patients. Aloe vera has a long association with herbal medicine, from the Ebers Papyrus from 16th century BCE. It is alleged to be effective in treatment of wounds, to improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in patients with ulcerative colitis. Evidence of the effects of aloe vera in the treatment of IBS, is however limited and contradictory. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Irritable Bowel Syndrome | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01400048 | ||||||||
| Other Study ID Numbers ICMJE | Aloe Vera AVH200 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Professor Magnus Simrén, Dept of Internal medicine, Sahlgrenska University Hospital | ||||||||
| Study Sponsor ICMJE | Sahlgrenska University Hospital, Sweden | ||||||||
| Collaborators ICMJE | Aloe Scandinavia AB | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sahlgrenska University Hospital, Sweden | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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