Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Bismuth; Neomycin; Procaine

Criteria

Inclusion Criteria:

• Consistency with the purposes of the study and all topics of FICT;

• Age above 12 years;

• Both sexes;

• Diagnosis of type UAR minor

Exclusion Criteria:

• Use of nutritional supplements such as iron, folic acid and vitamins of the B complex;

• immunocompromised;

• systemic diseases (endocrine-metabolic);

• rheumatic diseases;

• Pregnancy and lactation;

• Use of topical or systemic corticosteroids;

• UAR type major;

• UAR type Herpetiformis;

• UAR over 48 hours of development;

• Background allergic to any components of the formula.