Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis (AVIUC)

February 1, 2013 updated by: Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Tlalpan
      • D.f., Tlalpan, Mexico, 14000
        • Recruiting
        • National Institute of Medical Science and Nutrition, Salvador Zubirán
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with confirmed diagnosis by histopathology of Ulcerative Colitis with mild activity level clinical, Endoscopic and histological.
  • Extent of disease: pancolitis, ulcerative proctitis and left.
  • Being treated with 5 - aminosalicylates (5-ASA).
  • Belonging to the National Institute of Medical Sciences and Nutrition "Salvador Zubirán".
  • Signed informed consent.

Exclusion Criteria:

  • Autoimmune diseases (lupus, HIV, cancer and any hepatitis).
  • Another type of colitis (indeterminate, infectious drug and Crohn's Disease.
  • Previous total colectomy.
  • Body mass index less than 19.9 kg/m2 or greater than 40 kg/m2.
  • Patients in remission histology, clinical and endoscopic.
  • Under treatment with steroids, azathioprine, diuretics and anticoagulants.
  • Use Aloe Vera or some natural therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aloe Vera
Consume 200 ml of aloe vera gel per day over a period of three months
Placebo Comparator: water
Consume 200 ml of placebo per day over a period of three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full Mayo Score
Time Frame: 3 months
3 months
Interleukine - 6
Time Frame: 3 months
Quantification in mucosal Biopsy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jesús K Yamamoto-Furusho, MD, PhD, INCMNSZ
  • Principal Investigator: Lizzette C Alfaro, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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