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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2013 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Recruitment status was Recruiting

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

History of Changes

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:

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 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Gower-Rousseau C, Salomez JL, Dupas JL, Marti R, Nuttens MC, Votte A, Lemahieu M, Lemaire B, Colombel JF, Cortot A. Incidence of inflammatory bowel disease in northern France (1988-1990). Gut. 1994 Oct;35(10):1433-8.

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.

Bousoño C, Ramos E. Enfermedad Inflamatoria Intestinal. Bol Pediatr 46 (1): 91-99, 2006.

Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. Review.

Kandice, LK. Inflammatory Bowel Disease. Clinical Cornertone. Lower GI Disorders. 2002; 4(4);49-60.

Feagan BG, Greenberg GR, Wild G, Fedorak RN, Paré P, McDonald JW, Dubé R, Cohen A, Steinhart AH, Landau S, Aguzzi RA, Fox IH, Vandervoort MK. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med. 2005 Jun 16;352(24):2499-507.

Podolsky DK. Inflammatory bowel disease. N Engl J Med. 2002 Aug 8;347(6):417-29. Review.

Fonseca-Camarillo GC, Villeda-Ramírez MA, Sánchez-Muñoz F, Barreto-Zúñiga R, Domínguez-López A, Uribe-Esquivel M, Yamamoto-Furusho JK. [IL-6 and TNF-α gene expression in the rectal mucosal of patients with chronic idiopathic ulcerative colitis and controls]. Rev Gastroenterol Mex. 2009 Oct-Dec;74(4):334-40. Spanish.

Mañé Almero J. [In vivo experimental models of inflammatory bowel disease and colorectal cancer]. Nutr Hosp. 2007 Mar-Apr;22(2):178-89. Review. Spanish.

Blonski W, Buchner AM, Lichtenstein GR. Inflammatory bowel disease therapy: current state-of-the-art. Curr Opin Gastroenterol. 2011 Jul;27(4):346-57. doi: 10.1097/MOG.0b013e328347aef3. Review.

Park MY, Kwon HJ, Sung MK. Intestinal absorption of aloin, aloe-emodin, and aloesin; A comparative study using two in vitro absorption models. Nutr Res Pract. 2009 Spring;3(1):9-14. doi: 10.4162/nrp.2009.3.1.9. Epub 2009 Mar 31.

Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14. Review.

Bosques-Padilla FJ, Sandoval-García ER, Martínez-Vázquez MA, Garza-González E, Maldonado-Garza HJ. [Epidemiology and clinical characteristics of ulcerative colitis in north-eastern Mexico]. Rev Gastroenterol Mex. 2011 Jan-Mar;76(1):34-8. Spanish.

[Clinical guidelines for the diagnosis and treatment of chronic ulcerative colitis (CUC). Diagnosis. Usefulness of clinical data and laboratory analysis]. Rev Gastroenterol Mex. 2007 Jul-Sep;72(3):298-9. Spanish.

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

Wild GE, Drozdowski L, Tartaglia C, Clandinin MT, Thomson AB. Nutritional modulation of the inflammatory response in inflammatory bowel disease--from the molecular to the integrative to the clinical. World J Gastroenterol. 2007 Jan 7;13(1):1-7. Review.

Atherton P. Aloe vera revisited. British Journal of Phytotherapy 1998; 4(4): 176-183.

Holdsworth DK. Chromones in aloe species. I. Aloesin--a C-glucosyl-7-hydroxychromone. Planta Med. 1971 Apr;19(4):322-5.

Siddharthan K. Health insurance coverage of the immigrant elderly. Inquiry. 1991 Winter;28(4):403-12.

Avila H, Rivero J, Herrera F, Fraile G. Cytotoxicity of a low molecular weight fraction from Aloe vera (Aloe barbadensis Miller) gel. Toxicon. 1997 Sep;35(9):1423-30.

Curciarello J, De Ortúzar S, Borzi S, Bosia D. [Severe acute hepatitis associated with intake of Aloe vera tea]. Gastroenterol Hepatol. 2008 Aug-Sep;31(7):436-8. Spanish.

Bottenberg MM, Wall GC, Harvey RL, Habib S. Oral aloe vera-induced hepatitis. Ann Pharmacother. 2007 Oct;41(10):1740-3. Epub 2007 Aug 28.

Rabe C, Musch A, Schirmacher P, Kruis W, Hoffmann R. Acute hepatitis induced by an Aloe vera preparation: a case report. World J Gastroenterol. 2005 Jan 14;11(2):303-4.

El-Shemy HA, Aboul-Soud MA, Nassr-Allah AA, Aboul-Enein KM, Kabash A, Yagi A. Antitumor properties and modulation of antioxidant enzymes' activity by Aloe vera leaf active principles isolated via supercritical carbon dioxide extraction. Curr Med Chem. 2010;17(2):129-38. Review.

Kim K, Kim H, Kwon J, Lee S, Kong H, Im SA, Lee YH, Lee YR, Oh ST, Jo TH, Park YI, Lee CK, Kim K. Hypoglycemic and hypolipidemic effects of processed Aloe vera gel in a mouse model of non-insulin-dependent diabetes mellitus. Phytomedicine. 2009 Sep;16(9):856-63. doi: 10.1016/j.phymed.2009.02.014. Epub 2009 Mar 19.

Davis RH, Donato JJ, Hartman GM, Haas RC. Anti-inflammatory and wound healing activity of a growth substance in Aloe vera. J Am Podiatr Med Assoc. 1994 Feb;84(2):77-81.

Davis RH, Leitner MG, Russo JM, et al. Biological activity of Aloe vera. Med Sci Res ; 15: 235, 1987b.

Guo J, Xiao B, Zhang S, Liu D, Liao Y, Sun Q. Growth inhibitory effects of gastric cancer cells with an increase in S phase and alkaline phosphatase activity repression by aloe-emodin. Cancer Biol Ther. 2007 Jan;6(1):85-8.

Stochastic ESR analysis of rat liver and hepatoma mitochondrial lipids. Biophys Struct Mech. 1978 Apr 13;4(2):111-4.

Hatano T, Kusuda M, Inada K, Ogawa TO, Shiota S, Tsuchiya T, Yoshida T. Effects of tannins and related polyphenols on methicillin-resistant Staphylococcus aureus. Phytochemistry. 2005 Sep;66(17):2047-55. Review.

Saccù D, Bogoni P, Procida G. Aloe exudate: characterization by reversed phase HPLC and headspace GC-MS. J Agric Food Chem. 2001 Oct;49(10):4526-30.

Speranza G, Morelli CF, Tubaro A, Altinier G, Durì L, Manitto P. Aloeresin I, an anti-inflammatory 5-methylchromone from cape aloe. Planta Med. 2005 Jan;71(1):79-81.

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.

Langmead L, Makins RJ, Rampton DS. Anti-inflammatory effects of aloe vera gel in human colorectal mucosa in vitro. Aliment Pharmacol Ther. 2004 Mar 1;19(5):521-7.


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:


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

ClinicalTrials.gov processed this record on September 26, 2016

To Top