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

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Status and phase: Unknown; Early Phase 1

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Aloe Barbadensis Miller; Dietary Supplement: placebo water

Study type: Interventional

Funder types: Other

Identifiers

NCT01783119

REF.589

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Aloe Vera

Experimental group

Description:

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

Treatment:

Dietary Supplement: Aloe Barbadensis Miller

water

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo water