Evaluation of the efficacy and safety of Unani Formulations in Pityriasis Versicolor: A randomized controlled trial

Ethnopharmacological relevance: Pityriasis Versicolor (PV) is a commonly encountered infection of the skin caused by Malassezia species. Despite effective conventional antifungal drugs, the prevention and treatment of PV remain a challenge. The Unani pharmacopoeial preparations Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) have been used in the treatment of PV for a long time. The Unani practitioners recommend these formulations for the successful treatment of PV in clinical practice. Aim of the study: This study aimed to evaluate the efficacy and safety of Unani formulations IHA (oral) and HK (topical) in the treatment of PV. Materials and methods: A single centre, randomized, active-controlled, parallel-group and open-label clinical study was carried out in the outpatient departments of the National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, India. The participants diagnosed with PV of any gender aged between 18 and 60 years were randomized into the test group (n = 37) to receive oral IHA (10g/day) and topical HK and the active control group (n = 35) to receive oral Itraconazole (100 mg/day) and local Terbinafine (1%) for the period of 6 weeks. Of them, 30 participants in each group completed the duration of the protocol therapy. The outcome of this study was based on a per-protocol analysis of the data. The efficacy of the interventions was measured by post-treatment change in subjective clinical symptoms/signs, mean TSSS, IGA score, direct microscopy of fungal elements and DLQI. The dermal safety was assessed by Berger/Bowman Scoring Scale and systemic safety was evaluated by Urinalysis, haematological and biochemical parameters. Results: This study observed statistically and clinically significant post-treatment reduction in itching (test group vs. active control group; 73.4% vs. 89.1%), hypopigmentation (63.2% vs. 57.1%), hyperpigmentation (60% vs. 65.5%), and scaling (91.6% vs. 92.7%) (p < 0.001). The differences in mean TSSS (5.4 +/- 0.63 vs. 5.60 +/- 0.32), IGA score (2.07 +/- 0.15 vs. 1.74 +/- 0.08) and DLQI (9.6 +/- 2.06 vs. 9.04 +/- 2.7) were also found clinically and statistically significant (p < 0.001) in each group when compared baseline data to post-treatment. On inter-group comparison, the changes in mean TSSS and DLQI were not found statistically significant at p < 0.05. But, the change in the mean IGA score was significant (p = 0.03). Further, the mycological cure was observed in 100% and 76.7% of participants in the test group and the control group respectively. On comparing inter-group the effects of the interventions on direct microscopy were found statistically significant (p = 0.034). In addition, no significant change in urinalysis, biochemical and haematological parameters from baseline to post-treatment in each group was observed. Conclusion: This study concluded that the test drugs (IHA and HK) were safe and effective in the treatment of PV. The oral (IHA) and local (HK) Unani formulations were tolerated well by all the participants The efficacy and safety of the IHA and HK were comparable to the standard drugs (Itraconazole and Terbinafine).