RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-10

Study Completion Date

2010-05-10

Brief Summary

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Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.

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Detailed Description

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44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).

Conditions

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Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

22 patients were assigned to Group-A (5-ASA oral 800mg x 3 / day + 1 enema 60ml Aloe Vera gel / day) and 22 patients to Group-B (5-ASA oral 800mg x 3 / day + enema 60ml 1 Placebo / day).

Study Groups

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22 patients were assigned to Group-A

Group Type EXPERIMENTAL

Aloe vera gel

Intervention Type DRUG

22 patients were assigned to Group-B

Group Type PLACEBO_COMPARATOR

Aloe vera gel

Intervention Type DRUG

Interventions

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Aloe vera gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease.