Assessing the efficacy and safety of Unani pharmacopoeial formulations in dermatophytosis (quba) - a randomized controlled trial.

OBJECTIVES: The recent trends of rising unresponsive cases of dermatophytosis to conventional therapies pose a challenge in clinical practice. Unani medicine offers effective treatment for dermatophytosis. This study aimed to evaluate the efficacy and safety of the Unani herbo-mineral preparations Qurs-e-Asfar (QA) and Rogan-e-Narjeel (RN) in dermatophytosis. METHODS: This was a randomized, active-controlled and open-label clinical study. The participants diagnosed with dermatophytosis (n=78) randomized into treatment group (n=40) receiving oral QA (778 mg twice a day) and topical RN and control group (n=38) receiving oral Itraconazole (100 mg/day) and topical Terbinafine hydrochloride (1%) for 6 weeks. RESULTS: We found post-treatment improvement in itching by 86.3% vs. 78% (treatment vs. control group), erythema by 96.4% vs. 94.3%, scaling by 93% vs. 92.2% and peripheral raised margins by 82.3% vs. 81%. Furthermore, this study showed that the differences in the mean Total Signs and Symptoms Score (TSSS) and positive KOH mount were clinically and statistically significant (p<0.05) in both the groups. On comparing inter group, the differences in mean TSSS (p=0.07) and positive KOH mount (p=0.717) were found statistically insignificant. CONCLUSIONS: This study concludes that the formulations QA and RN were effective and safe in the treatment of dermatophytosis.

Olive oil and clove oil-based nanoemulsion for topical delivery of terbinafine hydrochloride: in vitro and ex vivo evaluation.

In this article, formulation studies for terbinafine hydrochloride nanoemulsions, prepared by high-energy ultrasonication technique, are described. Pseudo-ternary phase diagram was constructed in order to find out the optimal ratios of oil and surfactant/co-solvent mixture for nanoemulsion production. Clove and olive oils were selected as oil phase. Based on the droplet size evaluation, maximum nanoemulsion region were determined for formulation development. Further characterization included polydispersity index (PDI), zeta potential, Fourier transform infrared (FT-IR) spectroscopy, morphology, pH, viscosity, refractive index, ex vivo skin permeation, skin irritation, and histopathological examination. Droplet sizes of optimized formulations were in colloidal range. PDI values below 0.35 indicated considerably homogeneous nanoemulsions. Zeta potential values were from 13.2 to 18.1 mV indicating good stability, which was also confirmed by dispersion stability studies. Ex vivo permeation studies revealed almost total skin permeation of terbinafine hydrochloride from the nanoemulsions (96-98%) in 6 hours whereas commercial product reached only 57% permeation at the same time. Maximum drug amounts were seen in epidermis and dermis layers. Skin irritation and histopathological examination demonstrated dermatologically safe formulations. In conclusion, olive oil and clove oil-based nanoemulsion systems have potential to serve as promising carriers for topical terbinafine hydrochloride delivery.