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Aloe Vera in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Aloe vera effervescent tablet (AVH200)
Placebo control
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aloe vera effervescent tablet (AVH200)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

IBS symptoms

Secondary Outcome Measures

Full Information

First Posted
July 19, 2011
Last Updated
September 7, 2018
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Calmino group AB
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1. Study Identification

Unique Protocol Identification Number
NCT01400048
Brief Title
Aloe Vera in Irritable Bowel Syndrome
Official Title
Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Calmino group AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aloe vera effervescent tablet (AVH200)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Aloe vera effervescent tablet (AVH200)
Intervention Description
250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo control
Intervention Description
60mg Ascorbic acid
Primary Outcome Measure Information:
Title
IBS symptoms
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, MD, PhD
Organizational Affiliation
Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32314514
Citation
Ahluwalia B, Magnusson MK, Bohn L, Storsrud S, Larsson F, Savolainen O, Ross A, Simren M, Ohman L. Randomized clinical trial: Effects of Aloe barbadensis Mill. extract on symptoms, fecal microbiota and fecal metabolite profiles in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2020 Aug;32(8):e13860. doi: 10.1111/nmo.13860. Epub 2020 Apr 20.
Results Reference
derived

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Aloe Vera in Irritable Bowel Syndrome

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