We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aloe Vera in Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified April 2016 by Magnus Simrén, Sahlgrenska University Hospital, Sweden
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400048
First Posted: July 22, 2011
Last Update Posted: April 13, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Calmino group AB
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
  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
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

Resource links provided by NLM:


Further study details as provided by Magnus Simrén, Sahlgrenska University Hospital, Sweden:

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

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01400048     History of Changes
Other Study ID Numbers: Aloe Vera AVH200
First Submitted: July 19, 2011
First Posted: July 22, 2011
Last Update Posted: April 13, 2016
Last Verified: April 2016

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