Aloe Vera in Irritable Bowel Syndrome
This study is currently recruiting participants.
Verified January 2010 by Sahlgrenska University Hospital, Sweden
Sponsor:
Sahlgrenska University Hospital, Sweden
Collaborator:
Calmino group AB
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01400048
First received: July 19, 2011
Last updated: May 28, 2013
Last verified: January 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Irritable Bowel Syndrome |
Dietary Supplement: Aloe vera effervescent tablet (AVH200) Dietary Supplement: Placebo control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome |
Resource links provided by NLM:
Further study details as provided by Sahlgrenska University Hospital, Sweden:
Primary Outcome Measures:
- IBS symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Aloe vera effervescent tablet (AVH200) |
Dietary Supplement: Aloe vera effervescent tablet (AVH200)
250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo control
60mg Ascorbic acid
|
Detailed Description:
There is limited knowledge of the IBS pathophysiology, absence of biological markers and therefore few effective treatment options. IBS therefore 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- IBS according to the Rome III criteria
- Adults
Exclusion Criteria:
- other GI disorders
- other medical conditions
- were pregnancy or breast-feeding
- food allergy or intolerance to other than lactose
- ongoing intake of aloe vera products
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400048
Contacts
| Contact: Magnus Simrén, Professor | +46 31 342 81 07 | magnus.simren@medicine.gu.se |
| Contact: Stine Storsrud, PhD | +46 31 342 81 07 | stine.storsrud@vgregion.se |
Locations
| Sweden | |
| Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 413 45 | |
| Contact: Gisela Ringstrom, PhD +46 31 342 81 07 gisela.ringstrom@vgregion.se | |
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Calmino group AB
Investigators
| Principal Investigator: | Magnus Simrén, MD, PhD | Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden |
More Information
No publications provided
| Responsible Party: | Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden |
| ClinicalTrials.gov Identifier: | NCT01400048 History of Changes |
| Other Study ID Numbers: | Aloe Vera AVH200 |
| Study First Received: | July 19, 2011 |
| Last Updated: | May 28, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013