Efficacy Of Habbe Kibreet Sagheer And Dimad In Comparison With Itraconazole and Clotrimazole in Tinea Pedis- A Randomized Open Labelled Control Clinical Trial

Need of the study:

Tinea pedis, also known as athlete’s foot, is dermatophytosis of the feet, the most common fungal infection.1 The prevalence of tinea pedis increases with age,2 and it is higher in males than females.3 It affects at least 10% of the world’s population at any given time. Males are infected at about three Times more often than females.4 This is probably due to habitual and occupational differences between genders. Women participate less often in sports activities and they wear open shoes more often than males. Moreover, women devote more time to foot hygiene than men.5 Common causes of tinea pedis include T. rubrum, Trichophyton interdigitale, and Epidermophyton floccosum. Direct contact with the causative organism is the usual method of infection, which may occur through barefoot, contact between the feet and an infected surface in locker rooms and swimming pools. In the winter, the use of occlusive footwear is more common, and this leads to increased incidences of tinea pedis. Tinea pedis is more frequent in athletes and blue-collar workers.

In the conventional structure of medicine, the treatment of dermatophyte infection usually implies azole, imidazole, or allylamine derivatives in various dosage forms. Common drugs used are Fluconazole, Itraconazole, Griseofulvin, and Terbinafine, etc.6 Mild cases respond well to topical treatment, such as topical terbinafine, Ciclopirox, and econazole. severe cases and cases in which topical treatment has failed require systemic treatment, as one-third of tinea pedis cases failed to respond to topical therapy. In recent years we have seen a notable rise in the incidence of chronic dermatophyte infections which have proven strenuous to treat.7 In conventional systems of medicine, the identification of drugs that selectively kill or inhibit fungi but are not toxic to human cells has been highly complicated.8 Besides, some other factors like drug resistance, adverse drug reactions, recurrency, and chronicity of the disease are the obstacles. Problems with antifungal drugs and the emergence of more fungal species have created a heavy demand for new antifungal drugs.

In Unani medicine, tinea pedis is not defined separately, however, Unani physicians have described ‘QOOBA’ as a broader term that also includes Tinea pedis. Unani medicines possess the desired properties with widely varied dosage formulations that can cure tinea pedis, but these formulations are not scientifically evaluated. Hence there is a need to evaluate these preparations clinically and validate the efficacy/claim of Unani drugs mentioned in classical Unani literature which have been indicated and tested for centuries. Unani System of medicines has enormous potential in this field and a lot more work must be done. Therefore, the present study entitled “Efficacy ofḤabbe Kibreet Sagheer andḌimād in Comparison with Itraconazole and clotrimazole in Tinea Pedis- A Randomized Open Labelled Control Clinical Trial****” has been designed to validate and to provide effective management of Tinea Pedis.

 Review of Literature:

Dermatophytoses are fungal infections caused by three genera of fungi that can invade and multiply within keratinized tissue (hair, skin, and nails). These fungi collectively called “dermatophytes”, are alike in their physiology, morphology, and pathogenicity. The three genera are Microsporum, Trichophyton, and Epidermophyton; these genera that do not invade keratinized tissue in animals or humans are not considered dermatophytes.  The term “tinea” precedes the Latin name for the involved body site, e.g. “tinea pedis” refers to dermatophyte infection of the foot.9

 Tinea pedis is also known as a “Ringworm of the foot” and “Athlete’s foot”. Tinea pedis is a dermatophyte infection of the soles and interdigital web spaces of the feet. This condition is more common in adults than children and is found around the world, affecting both sexes. The lack of sebaceous glands and the moist environment created by occlusive shoes are important factors in the development of the tinea pedis. In fact, tinea pedis is uncommon in populations that do not wear shoes. However, the fungus may be acquired from going barefoot (locker rooms, gyms, public facilities).

The dermatophytes that are typically responsible for tinea pedis are T. rubrum (Most common) T. interdigitale (Previously T. mentagrophytes var. Interdigitale), T. mentagrophytes, E. floccosum, and T. tonsurans (in children).9

**Types of Tinea pedis:**10

Tinea pedis may present as any of four forms, or combinations thereof

 1. Interdigital type (Athlete’s foot): The most common presentation of tinea pedis begins as scaling, erythema, and maceration of the interdigital and sub-digital skin of the feet, particularly between the lateral 3rd and 4th and 4th and 5th toes.

 2. Chronic hyperkeratotic (Moccasin) type: In chronic hyperkeratotic type tinea pedis, there is patchy or diffuse scaling on the soles and the lateral and medial aspect of the feet, in a distribution like a moccasin on a foot.

 3. Vesiculobullous type: It is typically caused by zoophilic strains of T. interdigitale (former T. mentagrophytes var. mentagrophytes), features tense vesicles larger than 3mm in diameter, vesiculobullous pustules and bullae on the soles and periplantar areas.

 4. Acute ulcerative type: It is zoophilic T. interdigitale along with rampant bacterial superinfection with gram -ve organisms produces vesicles, pustules, and purulent ulcers on the plantar surface.

 According to the Unani system of medicine, Qooba is a type of roughness that is produced under the skin and causes itching. Sometimes it appears blackish and sometimes reddish in color.11 According to Ahmad bin Tabri ‘the cause of Qooba is Ghaleez Akhlāṭ especially Ghaleez Ḍam and Ghaleez Sawda’.11 It is due to sanguine (Ḍamvi) humour which is burnt and transformed into morbid melancholic humour.12 It is produced by *Mirrah Sawdaʼ.*13

The basic principles of management of Qooba include Tadeele Mizaj, Tanqiya mawad (Evacuation of morbid material) and Taskīn wa Tabrīd. The regimental therapy includes Faṣd (Venesection), Ḥammām (Bath), and Taʻlīq al-ʻAlaq(Leech therapy). Faṣd (Venesection) and drugs for evacuation for Khilṭ-e-sawdaʼ (Melancholic humour) should be used. Those drugs with Muḥallil, mulaṭṭif, musakkin, muṣaffī, muʻaddil, and muraṭṭib properties are to be used. Gandhak Maghsool, Filfil siyah, Namak Hindi, Aab-e-Leemu, etc. have the above-mentioned properties.11,14

Objectives of the study:

To evaluate the comparative efficacy of “Ḥabbe Kibreet Sagheer and Ḍimād withItraconazole and Clotrimazole inTinea Pedis.

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