Aloe Vera in Irritable Bowel Syndrome

NCT ID: NCT01400048

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aloe vera effervescent tablet (AVH200)

Group Type ACTIVE_COMPARATOR

Aloe vera effervescent tablet (AVH200)

Intervention Type DIETARY_SUPPLEMENT

250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®

Placebo

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

60mg Ascorbic acid

Interventions

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Aloe vera effervescent tablet (AVH200)

250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®

Intervention Type DIETARY_SUPPLEMENT

Placebo control

60mg Ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calmino group AB

UNKNOWN

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Simrén

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnus Simrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden

Locations

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

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32314514 (View on PubMed)

Other Identifiers

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Aloe Vera AVH200

Identifier Type: -

Identifier Source: org_study_id

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