- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783119
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis (AVIUC)
February 1, 2013 updated by: Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jesús K. Yamamoto-Furusho, PhD,MD
- Phone Number: 2710 +5554870900
- Email: kazuofurusho@hotmail.com
Study Locations
-
-
Tlalpan
-
D.f., Tlalpan, Mexico, 14000
- Recruiting
- National Institute of Medical Science and Nutrition, Salvador Zubirán
-
Contact:
- Jesús K Yamamoto-Furusho, MD, PhD
- Phone Number: 2710 +5554870900
- Email: kazuofurusho@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aloe Vera
Consume 200 ml of aloe vera gel per day over a period of three months
|
|
Placebo Comparator: water
Consume 200 ml of placebo per day over a period of three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Full Mayo Score
Time Frame: 3 months
|
3 months
|
|
Interleukine - 6
Time Frame: 3 months
|
Quantification in mucosal Biopsy
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jesús K Yamamoto-Furusho, MD, PhD, INCMNSZ
- Principal Investigator: Lizzette C Alfaro, INCMNSZ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Bosques-Padilla FJ, Sandoval-Garcia ER, Martinez-Vazquez MA, Garza-Gonzalez 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.
- Sanjurjo-García, J. L., Aranda-Jiménez, G., Garuño-Delgado, R., y García-Manzo, N. T. Guías clínicas de diagnóstico y tratamiento de la colitis ulcerativa crónica idiopática (CUCI). Diagnóstico. Utilidad de los datos clínicos y análisis de laboratorio.Rev. Gastroenterol Mex. 2007; 72(2):136-138.
- 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. doi: 10.3748/wjg.v13.i1.1.
- 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. doi: 10.1055/s-0028-1099649. No abstract available.
- 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. doi: 10.1016/s0041-0101(97)00020-2.
- Curciarello J, De Ortuzar S, Borzi S, Bosia D. [Severe acute hepatitis associated with intake of Aloe vera tea]. Gastroenterol Hepatol. 2008 Aug-Sep;31(7):436-8. doi: 10.1157/13125590. Spanish.
- Bottenberg MM, Wall GC, Harvey RL, Habib S. Oral aloe vera-induced hepatitis. Ann Pharmacother. 2007 Oct;41(10):1740-3. doi: 10.1345/aph.1K132. 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. doi: 10.3748/wjg.v11.i2.303.
- 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. doi: 10.2174/092986710790112620.
- 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. doi: 10.7547/87507315-84-2-77.
- 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. doi: 10.4161/cbt.6.1.3553.
- Stochastic ESR analysis of rat liver and hepatoma mitochondrial lipids. Biophys Struct Mech. 1978 Apr 13;4(2):111-4. doi: 10.1007/BF00539225.
- 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. doi: 10.1016/j.phytochem.2005.01.013.
- Saccu 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. doi: 10.1021/jf010179c.
- Speranza G, Morelli CF, Tubaro A, Altinier G, Duri L, Manitto P. Aloeresin I, an anti-inflammatory 5-methylchromone from cape aloe. Planta Med. 2005 Jan;71(1):79-81. doi: 10.1055/s-2005-837756.
- 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. doi: 10.1111/j.1365-2036.2004.01874.x.
- 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. doi: 10.1136/gut.35.10.1433.
- 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. doi: 10.1016/s1098-3597(02)90005-0.
- 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. doi: 10.1016/S0140-6736(07)60751-X.
- Feagan BG, Greenberg GR, Wild G, Fedorak RN, Pare P, McDonald JW, Dube 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. doi: 10.1056/NEJMoa042982.
- Podolsky DK. Inflammatory bowel disease. N Engl J Med. 2002 Aug 8;347(6):417-29. doi: 10.1056/NEJMra020831. No abstract available.
- Fonseca-Camarillo GC, Villeda-Ramirez MA, Sanchez-Munoz F, Barreto-Zuniga R, Dominguez-Lopez A, Uribe-Esquivel M, Yamamoto-Furusho JK. [IL-6 and TNF-alpha 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.
- Mane Almero J. [In vivo experimental models of inflammatory bowel disease and colorectal cancer]. Nutr Hosp. 2007 Mar-Apr;22(2):178-89. 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
January 31, 2013
First Submitted That Met QC Criteria
February 1, 2013
First Posted (Estimate)
February 4, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
February 1, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REF.589
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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