Abstract

Objective: To compare the therapeutic efficacy of kalachuchi (Plumeria acuminata Ait.) bark extract ointment (KO) and clotrimazole cream 1% (CC) in the treatment of otomycosis.
 Methods:
 Design: Randomized double blind controlled trial
 Setting: Outpatient otorhinolaryngology clinic of a tertiary private hospital
 Subjects: Patients aged 18-years-old and above diagnosed clinically to have otomycosis with a positive potassium hydroxide (KOH) smear were randomly assigned to kalachuchi (Plumeria acuminata Ait.) bark extract ointment or clotrimazole cream 1% in unlabeled containers. Self-application thrice daily for two weeks followed initial detailed instructions and demonstration. Symptoms, physical findings and repeat KOH smears were recorded after the first and second weeks of treatment.
 Results: Eighteen patients with otomycosis were enrolled in the study. There was one dropout per treatment group with no intention to treat. There were no statistically significant differences between KO and CC, with 75% (n=8) and 87.5% (n=8) cure rates, respectively. One subject in the KO arm reported severe ear pain.
 Conclusion: Kalachuchi extract ointment may be a promising topical antifungal agent. Multicenter clinical trials to establish its efficacy and safety as an effective alternative in the management of otomycosis should be conducted.
 Key words: Otomycosis, kalachuchi, Plumeria acuminata Ait., clotrimazole, clinical trial, herbal medicine

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