The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
BALI association oral suspension, 25 mg + 25 mg + 15 mg, oral. Three applications per day or more in case of pain, not exceeding six applications per day.
Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.
EMS
Hortolândia, São Paulo, Brazil
To assess the reduction in pain intensity after 3 days of treatment.
Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time frame: 3 days
To assess the reduction in pain intensity after the first application.
Difference in pain intensity 15 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time frame: 15 minutes
To assess the reduction in pain intensity during the treatment.
Difference in pain intensity after 5 and 7 days of treatment compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time frame: 5 and 7 days
Percentage of participants healed during treatment.
Percentage of participants healed after 3, 5, and 7 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the Likert scale. Likert scale is a five point scale: 0 = no pain and 4 = pain as bad as it could possibly be".
Time frame: 3, 5 and 7 days
Percentage of participants with no pain during treatment.
Percentage of participants with no pain after 3, 5, and 7 days of treatment, measured by the Likert scale. Likert scale is a five point scale: 0 = "no pain" and 4 = "pain as bad as it could possibly be".
Time frame: 3, 5 and 7 days
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To assess the percentage change in pain intensity from baseline during treatment.
Pain intensity will be evaluated by the VAS scale.The following calculations will be performed: ((D3, D5 or D7 - V0) / baseline) ×100%. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time frame: 3, 5 and 7 days