Effect of Unani formulation in Ring worm
- Conditions
- Tinea corporis,
- Registration Number
- CTRI/2021/01/030404
- Lead Sponsor
- Luqman Unani Medical College Hospital and Research Center Vijaypur
- Brief Summary
**Need for The Study:**
Dermatophytosis,also referred to as “tinea†is a very common clinical problem caused by superficialmycoses that infect skin, hair, and nails[1][2].According to WHO, the reported worldwide prevalence is about 20% to 25% [3][4],whereas approximately 30 to 70% adults suffer from asymptomatic superficialmycosis. The incidence of this disease increases with the passage of age [3].It is clinically manifested by well demarcated, annular, pruritic, and scalylesions with central clearing [1][5]. Dermatophytesare a larger group of over 51 species divided into six major genera i.e. Trichophyton,Microsporum, Epidermophyton, Nannizzia, Lophophyton, and Arthroderma [6]. Clinically,it is categorized by the name of body parts affected i.e. tinea capitis (head);tinea corporis (body); tinea cruris (groin); tinea unguium (nail), and tineapedis (feet) [1][5].
Amongthese subtypes, tinea corporis is the commonest type characterized by dermatophytosisof glaborous skin except palms, soles, and groin area [4][7]. Itis treated by both topical and oral antifungal agents in conventional medicine [1][4][5][7].Systemic antifungals include terbinafine; grisofluvin; itraconazole, and fluconazole[1][4][5][7],but failure reports of systemic therapy and resistance is the most alarming concern;especially mutation in the sequalene peroxidise enzyme that leads to the drugresistance[8]. High recurrence rate was also reported if these therapiesare discontinued [9]. Thus, it creates some potential space forfurther exploration of alternative treatment modality, and Unani medicine mayplay an important role in its management.
InUnani system of medicine, *QÅ«bÄ* is clinically synonymous with Tinea [10][11]. Moreover,*QÅ«bÄ* has been extensively described in various classical text books withspecial focus on its classification, pathology, prevention, and treatment [12]. *QÅ«bÄ*is defined as annular, dry, and pruritic eruptions [11]caused by amalgamation of *Mirra Sawda’* (bilious melanchole) into bloodor *Ruá¹Å«bat-i Ghalīẓ* and *Balgham-i Shor* (salinephlegm) [10]which is diverted towards the skin by *Quwwat-i Ṭabī’yya* (natural faculty) resulting in pruritic skin lesion [13].
Theline of treatment of *QÅ«bÄ* is based on *TeḥlÄ«l* (resolvent) and *Talá¹Ä«f-iMawÄd* (demulcent)[12];and there are many single and compound drugs mentioned in Unani classicalliterature such as *Marham-i DÄd* [14], *Ḥabb-iQÅ«bÄ* [15], *Ushaq*(*Dorema ammoniacum*) with vinegar [13]; *Samagh-i‘Arabi* (*Acacia gummi*) with *Sirka* [12], *Saresham**MÄhi* (*Gelatinum/Isinglass*) and *Kundar* (*Boswaliaserrate)* mixed with vinegar [13] fortopical application.
Amongthese, *Halela Zard* (*Terminalia chebula* Retz.) mixed with *Sirka*(vinegar) is recommended for the treatment of *QÅ«bÄ* [11][13]whichpossesses *TeḥlÄ«l* and *Talá¹Ä«f* properties. After the extensiveonline and hand search of literature sources on *QÅ«bÄ*, it’s found that notrial was conducted to validate the safety and efficacy of this drug in the patientsof *QÅ«bÄ*.
Keepingall facts in consideration, the present study has been designed to conduct on *QÅ«bÄ*with topical use of *Halela Zard* and *Sirka*, entitled “Therapeutic Evaluation of Topical *HalelaZard* in Treatment of *QÅ«bÄ* (Tinea Corporis) - A Randomised Standard Controlled Trialâ€.
**Review of Literature:**
Dermatophytosis,publicly called as ringworm[3][4], isa fungal infection of skin that have global significance. It is highlyprevalent in tropical and subtropical regions of the world [7]. Tineais a Latin word implying the worm of serpentine nature for skin lesion [3]. Dermatophytesare inoculated into the host skin through penetration followed by full-blownlesions mediated by proteases, serine-substilisins, and fungolysin which causedigestion of keratin network into oligopeptide or amino acid and act as potentimmunogenic stimuli[16].
Tinea corporis is asuperficial dermatophytic infection of skin other than those involving scalp,beard, hands, feet, and groin[4][7]. It is characterized by one or more circular,sharply circumscribed, and slightly erythematous dry scaly, usuallyhypopigmented patches [17]. In Unani literature, *QÅ«bÄ*is defined as roughness or scaly skin which is black or red in colour. The primary cause of *QÅ«bÄ*is *Mirra-Sawda’* (bilious melanchole) produced by excess intake of blackbile producing foods [10]. Moreover, *QÅ«bÄ*may be *DamawÄ«* (sanguineous) due to putrefied blood and morbid fluidmixing in the blood; *Raá¹Å«bÄ«* due to excess heat and infection and *SawdÄwÄ«*due to burnt humours or excessive black bile. The sanguineous lesion appearsreddish, while *Raá¹Å«bÄ«* lesion is whitish to reddish and yellowish incolour. However, the lesion of *SawdÄwÄ« QÅ«bÄ* appears deep brown in color [18].
According to *Ibn SÄ«nÄ*, *QÅ«bÄ*may be of certain types, such as *QÅ«bÄ DamawÄ«* (sanguineous) marked byoozing of fluid from the annular lesions; it may also be caused by salinephlegm mixed with abnormal black bile resulting in dry lesions. Few other typesare *QÅ«ba SÄ‘ī* (creeping ring worm), *KhabÄ«th* (malignant/morbid),and putrefied one[12].
*IsmÄÄ«l JurjÄnÄ«* said that*QÅ«bÄ* is caused by pruritic *Khilá¹-i* *FÄsid* (morbid humour) or *Khilt-i Ghaliz* (thick humour) and *SawdÄwÄ«*(black bilious) blood. The other potential cause is diversion of morbid matterfrom internal to external part of the body resulting in *QÅ«bÄ* under theinfluence of *Quwwat-i Tabī’yya* [13]. Itis treated on the principle of *Tanqiya* (eliminationof morbid material from the body), *TeḥlÄ«l* (resolution)and *Talá¹Ä«f-i MawÄd* (attenuation) [12].Hence, drugs which eliminate *Sawda’* out of the body are employed in itstreatment besides resolvent and dessicant drugs. A number of single andcompound drugs have been prescribed by Unani scholars in treatment of *QÅ«bÄ*.Moreover, various regimenal procedures such as *Ta‘lÄ«q al-‘Alaq* (leeching)[12]; *ḤammÄm*(therapeutic bath) [12][13]; *HijÄmabi’l Shará¹* (wet cupping) [13], and*Faá¹£d* (venesection) are also prescribed [10][12]. Amongthese single drugs, *Halela Zard* is a potent antifungal plant based singledrug and it possesses *Mushil-i á¹¢afra’* (cholagogue),*QÄbiá¸* (astringent), and *Muqawwi-i Mi’da* (stomachic) actionsas mentioned in Unani classical literature [19][20]. Therenowned Unani scholar *Ahmad al-Hasan al-JurjÄni* has written in his voluminousbook “*DhakhÄ«ra* *KhwÄrizm ShÄhi*†that *Halela Zard* (*Terminaliachebula*) should be mixed with *Sirka* (vinegar) and applied topicallyon the dermatophytic lesion[13].
*Halela Zard* (*Terminaliachebula*, Retz.) belongs to the family of Combretaceae. Its habitat isthroughout India, especially West Bengal; Tamil Nadu; West Coast, and Western Ghats.Its fruit is used for thee therapeutic purpose, and the chief chemicalconstituents are chebulin; palmitic acid, and behenic acid. The reported pharmacological actions are anti-inflammatory;carminative; digestive; laxative; purgative; antiseptic with indications inwound; ulcers; inflammation; skin diseases; neuropathy, and general debility [21]. DuttaB K and Rubini B , et al reported that the aqueous extract of *Terminalia chebula*fruit has potent anti-fungal activity, especially against *Trichophytonrubrum* [22] [23]. *Sirka*is an acidic agent which helps in reduction of growth of the fungus [16].
Thus,it is hypothesized that *Halela Zard* along with *Sirka* as a vehiclewill be very effective in amelioration of tinea corporis as the reportedantifungal action and its use in treatment of *QÅ«bÄ* by Unani scholars. Thecontrol drug “Terbinafine†is a standard drug for treatment of tinea with significantantifungal action [24][25][26].
Keepingthe above concepts and claim in view, the present study entitled “Therapeutic Evaluation of Topical *HalelaZard* in Treatment of *QÅ«bÄ* (Tinea Corporis) - A Randomised Standard Controlled Trial†has been designed for thetreatment of T. corporis.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Clinically as well as KOH diagnosed cases of Tinea corporis without nail and scalp involvement with Body Surface Area less than or equal to 20%.
Pregnancy and lactation Patient already on topical and/or systemic antifungal treatment (1 week of topical therapy and/or 4 weeks of systemic antifungal therapy before baseline visit) Diabetes mellitus Patients with immunosuppressive disease/drugs Super-imposed cases of tinea corporis Non-compliance to the trial protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method KOH examination At baseline and After completion of therapy
- Secondary Outcome Measures
Name Time Method Change in pruritus measured by VAS At baseline, 10th, 20th, 30th, and 40th day Patients global assessment Baseline and after trial Physicians global assessment Baseline and after trial Dermatology Life quality index Baseline and after trial
Trial Locations
- Locations (1)
Luqman Unani Medical College Hospital and Research Center
🇮🇳Bijapur, KARNATAKA, India
Luqman Unani Medical College Hospital and Research Center🇮🇳Bijapur, KARNATAKA, IndiaSUMAYYATASNEEM PARAPURPrincipal investigator7019622214drsumaiyyatasneem@gmail.com