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

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ClinicalTrials.gov Identifier: NCT01783119
Recruitment Status : Unknown
Verified January 2013 by Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Recruitment status was:  Recruiting
First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Aloe Barbadensis Miller Dietary Supplement: placebo water Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Full Mayo Score [ Time Frame: 3 months ]
  2. Interleukine - 6 [ Time Frame: 3 months ]
    Quantification in mucosal Biopsy


Eligibility Criteria
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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
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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
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Publications of Results:
Yamamoto-Furusho ,JK, Villalobos, JJ, Olvera, MA, Valdovinos, MA. Colitis ulcerosa crónica inespecífica (CUCI). Gastroenterología. 59. México, Ed. Méndez. 2006; 401-4.
Bousoño C, Ramos E. Enfermedad Inflamatoria Intestinal. Bol Pediatr 46 (1): 91-99, 2006.
Kandice, LK. Inflammatory Bowel Disease. Clinical Cornertone. Lower GI Disorders. 2002; 4(4);49-60.

Other Publications:
López-Rosés L, Olivencia-Palomar P. Colonoscopia. Rev. esp. enferm. dig. 100(6): 372-372; 2008.
Martinez-Benitez, B. Características morfológicas de la enfermedad intestinal inflamatoria idiopática. En: Yamamoto-Furusho, JK. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos.2010; México, D.F: Alfil
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
Atherton P. Aloe vera revisited. British Journal of Phytotherapy 1998; 4(4): 176-183.
Davis RH, Leitner MG, Russo JM, et al. Biological activity of Aloe vera. Med Sci Res ; 15: 235, 1987b.
León Sarabia JE, Rosales Clares V, Rosales Clares RA. Alternativas terapéuticas para pacientes portadores de colitis idiopática utilizando aloe vera l. (sábila). Una experiencia. REV CUBANA PLANT MED.3(3):102-5,1999.

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 Posted: February 4, 2013    Key Record Dates
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