Trial | NCT04753775  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    44
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.
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).
Study Started
Mar 10
2010
Primary Completion
Apr 10
2010
Study Completion
May 10
2010
Last Update
Feb 15
2021

22 patients were assigned to Group-A Experimental

22 patients were assigned to Group-A

22 patients were assigned to Group-B Placebo Comparator

22 patients were assigned to Group-B

Criteria 

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.

Exclusion Criteria:

an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance
No Results Posted