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

NCT01783119 | Unknown Early Phase 1 DMC

• 1 other identifier: REF.589
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Aloe Vera

Outcome Measures

Primary Outcomes (2)

• Full Mayo Score

  3 months

• Interleukine - 6

  Quantification in mucosal Biopsy

  3 months

Study Arms (2)

Aloe Vera

EXPERIMENTAL

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

Dietary Supplement: Aloe Barbadensis Miller

water

PLACEBO COMPARATOR

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

Dietary Supplement: placebo water

Interventions

Aloe Barbadensis Miller DIETARY_SUPPLEMENT

Aloe Vera

placebo water DIETARY_SUPPLEMENT

water

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: lead

Study Sites (1)

National Institute of Medical Science and Nutrition, Salvador Zubirán

D.f., Tlalpan, 14000, Mexico

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jesús K Yamamoto-Furusho, MD, PhD

  INCMNSZ

  STUDY CHAIR

• Lizzette C Alfaro

  INCMNSZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús K. Yamamoto-Furusho, PhD,MD

CONTACT

+5554870900; kazuofurusho@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

ME (1)