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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2013 by Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01783119

First Posted: February 4, 2013

Last Update Posted: February 4, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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	Early Phase 1


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

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Aloe vera

U.S. FDA Resources

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

Primary Outcome Measures:

Full Mayo Score [ Time Frame: 3 months ]
Interleukine - 6 [ Time Frame: 3 months ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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Yamamoto-Furusho JK. Clinical epidemiology of ulcerative colitis in Mexico: a single hospital-based study in a 20-year period (1987-2006). J Clin Gastroenterol. 2009 Mar;43(3):221-4. doi: 10.1097/MCG.0b013e31817a76b4.

Knigge KL. Inflammatory bowel disease. Clin Cornerstone. 2002;4(4):49-60. Review.

Yamamoto-Furusho ,JK, Villalobos, JJ, Olvera, MA, Valdovinos, MA. Colitis ulcerosa crónica inespecífica (CUCI). Gastroenterología. 59. México, Ed. Méndez. 2006; 401-4.

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Villeda-Ramirez M.A. Etiopatogenia de la enfermedad inflamatoria intestinal. En: Yamamoto-Furusho, JK.. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos. 2010; México, D.F: Alfil

World Healh Organization. National policy on traditional medicine and regulation of herbal medicines .Report of a WHO global survey. Geneve 2005

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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
First Submitted:	January 31, 2013
First Posted:	February 4, 2013
Last Update Posted:	February 4, 2013
Last Verified:	January 2013

Keywords provided by Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran:


Ulcerative Colitis Aloe Vera

Additional relevant MeSH terms:


Inflammation Colitis Ulcer Colitis, Ulcerative Pathologic Processes Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases

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