Status:

COMPLETED

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

Lead Sponsor:

Ospedale Sandro Pertini, Roma

Conditions:

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

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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.

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance

Key Trial Info

Start Date :

March 10 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 10 2010

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT04753775

Start Date

March 10 2010

End Date

May 10 2010

Last Update

February 15 2021

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