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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01400048
Other study ID # Aloe Vera AVH200
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date March 2017

Study information

Verified date September 2018
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Aloe vera effervescent tablet (AVH200)
250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®
Placebo control
60mg Ascorbic acid

Locations

Country Name City State
Sweden Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital Gothenburg

Sponsors (2)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Calmino group AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary IBS symptoms 4 weeks
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