RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Not Applicable
Completed
- Conditions
- Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
- Interventions
- Registration Number
- NCT04753775
- Lead Sponsor
- Ospedale Sandro Pertini, Roma
- 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) or enema (60 ml placebo) (n = 22, Group B).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 22 patients were assigned to Group-A Aloe vera gel 22 patients were assigned to Group-A 22 patients were assigned to Group-B Aloe vera gel 22 patients were assigned to Group-B
- Primary Outcome Measures
Name Time Method endoscopic remission 4 weeks
- Secondary Outcome Measures
Name Time Method