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
Sponsor:
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
  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
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 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 July 24, 2014