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

Ulcerative Colitis Clinical Trial

— AVIUC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01783119
• Other study ID #: REF.589
• Status: Recruiting
• Phase: Phase 0
• First received: January 31, 2013
• Last updated: February 1, 2013
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: Jesús K. Yamamoto-Furusho, PhD,MD
• Phone: +5554870900
• Email: kazuofurusho[@]hotmail.com
• Is FDA regulated: No
• Health authority: México: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Aloe Barbadensis Miller

• placebo water

Locations

Country	Name	City	State
Mexico	National Institute of Medical Science and Nutrition, Salvador Zubirán	D.f.	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (39)

[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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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; — View Citation

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-a gene expression in the rectal mucosal of patients with chronic idiopathic ulcerative colitis and control — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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

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. — View Citation

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.

López-Rosés L, Olivencia-Palomar P. Colonoscopia. Rev. esp. enferm. dig. 100(6): 372-372; 2008.

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

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

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

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. — View Citation

* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full Mayo Score		3 months	Yes
Primary	Interleukine - 6	Quantification in mucosal Biopsy	3 months	Yes