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

Ospedale Sandro Pertini, Roma

Status: Completed

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

Treatments: Drug: Aloe vera gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04753775

Rif. 1836/11.03.10

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups, including a placebo group

22 patients were assigned to Group-A

Experimental group

Description:

22 patients were assigned to Group-A

Treatment:

Drug: Aloe vera gel

22 patients were assigned to Group-B

Placebo Comparator group

Description:

22 patients were assigned to Group-B

Treatment:

Drug: Aloe vera gel