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

This study is currently recruiting participants.
Verified January 2013 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor:
Information provided by (Responsible Party):
Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01783119
First received: January 31, 2013
Last updated: February 1, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Dietary Supplement: Aloe Barbadensis Miller
Dietary Supplement: placebo water
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:

Primary Outcome Measures:
  • Full Mayo Score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Interleukine - 6 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Quantification in mucosal Biopsy


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aloe Vera
Consume 200 ml of aloe vera gel per day over a period of three months
Dietary Supplement: Aloe Barbadensis Miller
Placebo Comparator: water
Consume 200 ml of placebo per day over a period of three months
Dietary Supplement: placebo water

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783119

Contacts
Contact: Jesús K. Yamamoto-Furusho, PhD,MD +5554870900 ext 2710 kazuofurusho@hotmail.com

Locations
Mexico
National Institute of Medical Science and Nutrition, Salvador Zubirán Recruiting
D.f., Tlalpan, Mexico, 14000
Contact: Jesús K Yamamoto-Furusho, MD, PhD    +5554870900 ext 2710    kazuofurusho@hotmail.com   
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Investigators
Study Chair: Jesús K Yamamoto-Furusho, MD, PhD INCMNSZ
Principal Investigator: Lizzette C Alfaro INCMNSZ
  More Information

Publications:

Responsible Party: Jesús Kazuo Yamamoto Furusho, MD PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01783119     History of Changes
Other Study ID Numbers: REF.589
Study First Received: January 31, 2013
Last Updated: February 1, 2013
Health Authority: México: Ethics Committee

Keywords provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
Ulcerative Colitis
Aloe Vera

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammation
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014