A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, STANDARD CONTROLLED CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF UNANI FORMULATIONS- QURS-E- ASFAR(O) AND ROGHAN-I-NARJIL(L) WITH ITRACONAZOLE(O) AND TERBINAFINE(L) IN THE MANAGEMENT OF QŪBĀ(DERMATOPHYTOSIS)

QÅ«bÄ (Dermatophytosis) is a group of fungal infections of keratinized tissues like the epidermis, hair and nails[1]. QÅ«bÄ (Dermatophytic infection) is one of the commonest and oldest diseases of the skin. This clinical problem is encountered in more than 50% of the patients who were attending to the dermatology departments.[2]  As per WorldHealth Organizations (WHO), the prevalence of superficial fungal infection worldwide has been found to be 20-25% and it is more prevalent in tropical and subtropical countries like India where the heat and humidity is high throughout the year.[3]  The estimated lifetime risk of acquiring Dermatophytosis is between 10-20%.[4]

In South India, QÅ«bÄ is more prevalent because of having hot and humid climate which is more favorable for the development of the superficial mycoses.[1]

QÅ«bÄ (dermatophyte infection) is extremely common and usually caused by the fungi of the Microsporum, Trichophyton and Epidermophyton species.[5] They produce keratinases which degrade the keratin and thus, invade the superficial skin tissue.[5],[6]The infections due to these pathogens are generally cutaneous and restricted to the non-living, cornified layers of the skin.[6] The fungi can be transmitted through soil known as geophilic or by the animals i.e. zoophilic or it can remain in human skin (anthrophilic).[5]

QÅ«bÄ (Dermatophytosis) also have many ill impact on the patient’s quality of life. The lives of the families of patients with QÅ«bÄ may be affected. The patient may experience severe symptoms, especially itch, sometimes pain, discomfort and can become profoundly psychologically disturbed. The choice of clothes may be restricted. Social activities such as going out with friends or taking parts in sports, swimming or other physical activities may become difficult, often because of a reluctance to allow others to see the diseased skin what others may think.[7] The itch, appearance may interfere with work and may cause disturbed sleep.

In conventional medicine, certain antifungal drugs like  Terbinafine, Itraconazole, Flucanazole, Ketoconazole, Clotrimazole are used in the management of dermatophytosis with various degrees of resistance and certain side effects such as erythema, itching, dryness, irritation and urticaria, nausea, diarrhea,abdominal pain, headache, rashes, etc.[8]

Hence, because of the more prevalence of this disease and the significant impact on the quality of life and because of the conventional medicine’s side effects, there is a dire need to search for those formulations which are more effective and safe and which can improve the quality of life of the patients.

There are many formulations which are being used in the QÅ«bÄ like Roghan-i NÄrjÄ«l,[9][10]Qurá¹£-I Aá¹£far[9], Marham-e-kharishJadeed,[9]Marham-e-QÅ«bÄ,[9]Habb-e- QÅ«bÄ,[9]etc. Moreover drugs possessing the properties of MusaffÄ«, Mujaffif, JÄlÄ«, mudammil-e-Qurūḥ, Musakkin, Daf‘a-e-kharish, Muḥallil, Daf‘-iUfÅ«natare used in the management of the QÅ«bÄ such as, Gandhak(sulphur)[11], Sang-iJarÄhat(Magnesium silicate)[11], TutiyaSabz(Copper sulphate),[11]Naushadar(Ammonium chloride),[11]Suhaga(Borax),[12]Roghan-ikunjad(Sesamum indicum L),[11]etc.

Although, above mentioned formulations were used by many ancient Unani physicians and still are being used but some of them are not yet scientifically evaluated on modern parameters. . Hence, in order to evaluate efficacy and safety of Qurá¹£-i Aá¹£far[9] and Roghan-i NÄrjÄ«l[9],[10] in the management of QÅ«bÄ,the present clinical trial entitled “A Randomized Parallel Group Open Label Standard Controlled Clinical Study to compare the Efficacy and Safety of Unani Formulations – Qurá¹£-i Aá¹£far (O) and Roghan-i NÄrjÄ«l (L) with Itraconazole (O) and Terbinafine (L) in the Management of QÅ«bÄ (Dermatophytosis)†has been designed.