Efficacy and safety of Majoon Ushba oral and Marham Raal topical in tinea corporis – A randomized open-labeled active-controlled clinical trial

Dermatophytosis is a fungal infection in the skin's stratum corneum layer caused by species of three genera: Trichophyton, Microsporum, and Epidermophyton, and affecting 20–25% of the world population with varying geographic distribution1,2. The most common agents of superficial fungal infections worldwide are dermatophytes. The infection is widespread in developing countries, especially in tropical and subtropical countries like India resulting in significant distress to the patients socially, emotionally, and financially3,4. Tinea corporis is the most frequent form of dermatophytosis5, in which the glabrous skin is infected by dermatophytes, except palms, soles, and groins, and clinically characterized by annular or arcuate lesions with relative clearing in the center and an active periphery6. Dermatophytosis is now becoming a cause of anxiety and trepidation for dermatologists, though the treatment is available and prescribed successfully still there has been a steady rise in the incidence and increasing rate of treatment failure in dermatophyte infection7,8. Conventional antifungal agents such as chlorhexidine and imidazole derivatives have limited use, due to their common side effects such as hepatotoxicity, nausea, diarrhea, and impotency, the use is restricted in pregnant and young people9.

Unani medicine is one of the most ancient traditional systems of medicine and has its own conceptual framework for studying health and disease in human beings10. The clinical presentation of tinea corporis is similar to Quba a skin disease that develops due to disturbance in the normal equilibrium of normal humor (Blood, Bile, Phlegm, and Black Bile) in Unani medicine. Quba is described elaborately in classical textbooks and treated successfully by physicians of Unani Medicine like Avicenna and Rhazes11,12. Quba may develop due to the accumulation of abnormal humor the in body or skin, the abnormal humor may be either liquid and watery acute blood mixed with black bile or black bile itself. The treatment of Quba is based on the involved humor that needs to be removed first from the body by “Nuzj concoction of morbid humor and “Tanqia” its elimination from the body with pharmacological intervention or by a suitable regime like “Fasd” venesection, “Hijama” wet cupping and “Irsal-e-Alaq” medicinal leech therapy11, 12, 13, followed by topical application of herbal, mineral and animal origin drugs in different dosage form like ointment, cream oil, powder, etc. Various treatment (systemic and/or topical) modalities and pharmacological preparations have been described to effectively manage Quba in Unani medicine11, 12, 13. Phytotherapy (Ilaj bil Dawa) is the most frequently used mode of treatment that includes crude drugs, derived from plant, animal and mineral sources and used either in single or in combination preparation in different dosage forms and the vast majority of the ingredients of a combination preparation are of herbal origin10.

Medicinal plants are important sources for the treatment of severe pathogenic infections, which can be associated with the presence of bioactive compounds. The emergence of resistant fungal pathogens and the limited choice of antifungal drugs motivate scholars to explore and develop alternative antifungal agents used in traditional medicine14. Majoon Ushba (MU), is a polyherbal preparation in a semisolid dosage form used orally for skin disorders (Table 1.). MU is composed of natural medicinal plants, including Phyllanthus emblica Linn, Cuscuta reflexa Roxb., Smilax aristolochiifolia Mill. Ipomoea turpethum (L.) R. Br., Polypodium vulgare L., Terminalia bellirica (Gaertn.) Roxb., Cassia angustifolia Vahl, Fumaria officinalis L.15. The biomedical in vitro and in vivo studies of the herbal ingredients revealed useful bioactivities like antioxidant, antimicrobial, antifungal, anti-inflammatory, and wound healing activities16, 17, 18, 19, 20, 21. Marham Raal (MR) a combination preparation in an ointment dosage form is used topically for ulceration and skin conditions. MR is composed of herbal and animal-origin drugs (Table 1.), which include Vateria indica L., Cinnamomum camphora (L.) J.Presl, Acacia catechu (L.f.) Willd., Beeswax, and Ghee (clarified butter fat)22. The biomedical studies of the ingredients like Cinnamomum camphor and Acacia catechu revealed antioxidant, antimicrobial, antifungal, and anti-inflammatory activities, the Cinnamomum camphora leaf essential oil showed good antifungal activity against Trichophyton rubrum.23,24.

Unani medicine lacks evidence-based anti-fungal therapy for dermatophytosis, although, there are formulations that are indicated and tested for centuries in its treatment. Now resources of Unani medicine are explored for utilization of its therapeutic potential in the development of safe and effective natural product-based drugs. Hence, this study was designed to validate the efficacy and safety of Majoon Ushba and Marham Raal in comparison to Terbinafine 1% cream for the effective management of tinea corporis on scientific parameters.

留言 (0)

沒有登入
gif