Aloe Vera in Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Sahlgrenska University Hospital, Sweden
Calmino group AB
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden Identifier:
First received: July 19, 2011
Last updated: April 12, 2016
Last verified: April 2016
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 2017
Estimated Primary Completion Date: December 2016 (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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden Identifier: NCT01400048     History of Changes
Other Study ID Numbers: Aloe Vera AVH200 
Study First Received: July 19, 2011
Last Updated: April 12, 2016
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes processed this record on May 02, 2016