Aloe Vera in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01400048
Recruitment Status : Unknown
Verified April 2016 by Magnus Simrén, Sahlgrenska University Hospital, Sweden.
Recruitment status was:  Recruiting
First Posted : July 22, 2011
Last Update Posted : April 13, 2016
Calmino group AB
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Aloe vera effervescent tablet (AVH200) Dietary Supplement: Placebo control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome
Study Start Date : January 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. IBS symptoms [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400048

Contact: Magnus Simrén, Professor +46 31 342 81 07
Contact: Stine Storsrud, PhD +46 31 342 81 07

Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Gisela Ringstrom, PhD    +46 31 342 81 07   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Calmino group AB
Principal Investigator: Magnus Simrén, MD, PhD Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden

Responsible Party: Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden Identifier: NCT01400048     History of Changes
Other Study ID Numbers: Aloe Vera AVH200
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases