Formulação, avaliação das características físico-químicas, microbiológicas e da atividade cicatricial de uma pomada à base de Libidibia ferrea : um ensaio clínico

Abstract

The study aimed to formulate an ointment based on Libidibia ferrea and evaluate its healing activity in vivo. This was an experimental study of the phase I clinical trial type, double blind to evaluate safety and preliminary clinical response. The ointments for the clinical trial were produced and evaluated using the physical-chemical quality control tests recommended by the Brazilian Pharmacopoeia. To this end, 30 participants were selected, recruited from February to November 2024, according to inclusion criteria. Two groups were evaluated in the study: Test Group – Jucá Ointment and Negative Control Group – Ointment without active ingredient. After signing the TCLE, participants received the ointment and a prescription for use to begin application 24 hours after the surgical procedure, applying it twice a day, for 10 days. During this same time, patients were monitored, clinically evaluated three times, throughout the tissue repair process to analyze healing time using clinical indicators. Pain was measured using a Likert-type visual numerical scale and, at the end of the third assessment, the participant was asked to answer a questionnaire about the acceptability of the herbal treatment. Statistical analysis was performed using the R software, respecting the 95% confidence interval. The Chi-Square, Mann-Whitney, Friedman statistical tests and the Random Effects technique were used to analyze the associations. The results demonstrated that in both batches, the formulations presented adequate physicochemical characteristics and absence of contamination. As for the clinical trial, all study participants were female. No statistically significant differences were detected between the times evaluated and clinical indicators of healing (p≥0.05). However, it is suggested that patients who received treatment with Jucá ointment presented more uniform clinical parameters compared to the control group. A significant relationship was observed with time and clinical indicators of edema and pain. It was found that 90% of the participants showed knowledge and use of Jucá prior to the study, 100% of the patients did not show any fear/afraid of using herbal medicines, and the totality enjoyed knowing that a herbal medicine could be used in this study aimed at dental use. Considering this study a Phase I clinical trial, it can be concluded that the Jucá-based formulation did not present any changes in quality control analyzes and there was no statistically significant difference between the Jucá ointment and the Placebo ointment. It is necessary to carry out new randomized clinical studies focused on the healing effect and with a larger sample size, so that the healing effect of Jucá-based ointment on the oral mucosa can be analyzed.