Clinical efficacy and safety of a pharmacopial polyherbal Unani formulation in pityriasis versicolor: a comparative randomized single-blind study.

BACKGROUND

Pityriasis versicolor (PV) is a common superficial fungal infection of skin caused by the fungus, Malassezia furfur. It can occur at any age but occurs mainly during adolescence and typically presents with hypopigmented or hyperpigmented scaling plaques, generally on the trunk and upper arms. It often poses a therapeutic challenge. In the Unani system of medicine, many herbal drugs are used empirically for its treatment.

OBJECTIVES

The objective of this study was to evaluate safety and efficacy of a topical Polyherbal Unani formulation in the management of PV on scientific parameters.

DESIGN

This was a randomized, single-blind, standard controlled study.

LOCATION: This study was performed in the Dermatology Outpatient Department, National Institute of Unani Medicine, Bangalore, India.

SUBJECTS AND INTERVENTIONS: Forty-six (46) patients with PV were included in the study after taking informed consents and were randomly allocated to test and control groups. In the test group, a polyherbal formulation was advised for topical application while in the control group, sodium thiosulphate lotion (20%) was advised locally for a duration of 1 month. The assessment of the severity of PV and efficacy of treatment in both groups was carried out using the Total Sign and Symptom Score (TSSS) scale. Data were analyzed with the Instat Graph pad.

RESULTS

The mean±standard error of the mean (SEM) scores of TSSS in the test group were 7.7±1.174 and 0.9±0.7881 before and after treatment, respectively, while it was 6.9±0.8756 and 1.2±0.7888 in the control group before and after treatment, respectively. Mean±SEM of TSSS of both groups was found to be significantly lowered (p<0.001) after treatment when compared with mean±SEM of TSSS before treatment. However, the polyherbal formulation showed precedence over the standard drug by exhibiting comparatively quicker response. Furthermore, no unpleasant side-effects were observed in the test group during and after the study.

CONCLUSIONS

This study concluded that polyherbal Unani formulation is safe, effective, and superior to standard drug in the treatment of PV.