search
Back to results

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

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Early Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Aloe Barbadensis Miller
placebo water
Sponsored by
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Aloe Vera

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Medical Science and Nutrition, Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aloe Vera

water

Arm Description

Consume 200 ml of aloe vera gel per day over a period of three months

Consume 200 ml of placebo per day over a period of three months

Outcomes

Primary Outcome Measures

Full Mayo Score
Interleukine - 6
Quantification in mucosal Biopsy

Secondary Outcome Measures

Full Information

First Posted
January 31, 2013
Last Updated
February 1, 2013
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
search

1. Study Identification

Unique Protocol Identification Number
NCT01783119
Brief Title
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
Acronym
AVIUC
Official Title
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Aloe Vera

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aloe Vera
Arm Type
Experimental
Arm Description
Consume 200 ml of aloe vera gel per day over a period of three months
Arm Title
water
Arm Type
Placebo Comparator
Arm Description
Consume 200 ml of placebo per day over a period of three months
Intervention Type
Dietary Supplement
Intervention Name(s)
Aloe Barbadensis Miller
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo water
Primary Outcome Measure Information:
Title
Full Mayo Score
Time Frame
3 months
Title
Interleukine - 6
Description
Quantification in mucosal Biopsy
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesús K. Yamamoto-Furusho, PhD,MD
Phone
+5554870900
Ext
2710
Email
kazuofurusho@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús K Yamamoto-Furusho, MD, PhD
Organizational Affiliation
INCMNSZ
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lizzette C Alfaro
Organizational Affiliation
INCMNSZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Medical Science and Nutrition, Salvador Zubirán
City
D.f.
State/Province
Tlalpan
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús K Yamamoto-Furusho, MD, PhD
Phone
+5554870900
Ext
2710
Email
kazuofurusho@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22001864
Citation
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.
Results Reference
background
PubMed Identifier
21592901
Citation
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.
Results Reference
background
PubMed Identifier
18402220
Citation
[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. No abstract available. Spanish.
Results Reference
background
Citation
López-Rosés L, Olivencia-Palomar P. Colonoscopia. Rev. esp. enferm. dig. 100(6): 372-372; 2008.
Results Reference
background
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
Results Reference
background
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
Results Reference
background
Citation
World Healh Organization. National policy on traditional medicine and regulation of herbal medicines .Report of a WHO global survey. Geneve 2005
Results Reference
background
PubMed Identifier
17206749
Citation
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.
Results Reference
background
Citation
Atherton P. Aloe vera revisited. British Journal of Phytotherapy 1998; 4(4): 176-183.
Results Reference
background
PubMed Identifier
5573544
Citation
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.
Results Reference
background
PubMed Identifier
1761313
Citation
Siddharthan K. Health insurance coverage of the immigrant elderly. Inquiry. 1991 Winter;28(4):403-12.
Results Reference
background
PubMed Identifier
9403965
Citation
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.
Results Reference
background
PubMed Identifier
18783689
Citation
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.
Results Reference
background
PubMed Identifier
17726067
Citation
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.
Results Reference
background
PubMed Identifier
15633238
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. doi: 10.3748/wjg.v11.i2.303.
Results Reference
background
PubMed Identifier
19941474
Citation
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.
Results Reference
background
PubMed Identifier
19303272
Citation
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.
Results Reference
background
PubMed Identifier
8169808
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. doi: 10.7547/87507315-84-2-77.
Results Reference
background
Citation
Davis RH, Leitner MG, Russo JM, et al. Biological activity of Aloe vera. Med Sci Res ; 15: 235, 1987b.
Results Reference
background
PubMed Identifier
17172820
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. doi: 10.4161/cbt.6.1.3553.
Results Reference
background
PubMed Identifier
206295
Citation
Stochastic ESR analysis of rat liver and hepatoma mitochondrial lipids. Biophys Struct Mech. 1978 Apr 13;4(2):111-4. doi: 10.1007/BF00539225.
Results Reference
background
PubMed Identifier
16153408
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. doi: 10.1016/j.phytochem.2005.01.013.
Results Reference
background
PubMed Identifier
11599983
Citation
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.
Results Reference
background
PubMed Identifier
15678379
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
14987320
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. doi: 10.1111/j.1365-2036.2004.01874.x.
Results Reference
background
PubMed Identifier
7959201
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. doi: 10.1136/gut.35.10.1433.
Results Reference
result
PubMed Identifier
19057395
Citation
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.
Results Reference
result
PubMed Identifier
12739326
Citation
Knigge KL. Inflammatory bowel disease. Clin Cornerstone. 2002;4(4):49-60. doi: 10.1016/s1098-3597(02)90005-0.
Results Reference
result
Citation
Yamamoto-Furusho ,JK, Villalobos, JJ, Olvera, MA, Valdovinos, MA. Colitis ulcerosa crónica inespecífica (CUCI). Gastroenterología. 59. México, Ed. Méndez. 2006; 401-4.
Results Reference
result
Citation
Bousoño C, Ramos E. Enfermedad Inflamatoria Intestinal. Bol Pediatr 46 (1): 91-99, 2006.
Results Reference
result
PubMed Identifier
17499606
Citation
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.
Results Reference
result
PubMed Identifier
15958805
Citation
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.
Results Reference
result
PubMed Identifier
12167685
Citation
Podolsky DK. Inflammatory bowel disease. N Engl J Med. 2002 Aug 8;347(6):417-29. doi: 10.1056/NEJMra020831. No abstract available.
Results Reference
result
PubMed Identifier
20423763
Citation
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.
Results Reference
result
PubMed Identifier
17416034
Citation
Mane Almero J. [In vivo experimental models of inflammatory bowel disease and colorectal cancer]. Nutr Hosp. 2007 Mar-Apr;22(2):178-89. Spanish.
Results Reference
result
PubMed Identifier
21654383
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.
Results Reference
result
PubMed Identifier
20016696
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs