Therapeutic evaluation of Topical Halela Zard in treatment of Quba (Tinea Corporis) - A randomised Standard Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- KOH examination
研究概览
简要总结
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«bÄis 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«bÄwith 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«bÄis defined as roughness or scaly skin which is black or red in colour. The primary cause of QÅ«bÄis Mirra-Sawda’ (bilious melanchole) produced by excess intake of blackbile producing foods [10]. Moreover, QÅ«bÄmay 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«bÄmay 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 thatQÅ«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], andFaá¹£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),QÄbiḠ(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 chebulafruit has potent anti-fungal activity, especially against Trichophytonrubrum [22] [23]. Sirkais 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.
Listof References:
-
Kim B Y, Thomas J L. Approach to thePatient with a Skin Disorder. In: Jameson JL, Kasper DL, Longo DL, Fauci AS,Hauser SL, Loscalzo J, editors. Harrison’s Principles of Internal Medicine,volume-1. 20th ed. NEW YORK: Mc-Grill Education; 2018. p. 335–6.
-
HENRY W. LIM. Goldman-Cecil Medicine. In: LEE G, ANDREW S,editors. Goldman-Cecil Medicine. 25th ed. NEW YORK: Elsevier; 2016. p. 2670.
-
Carol A K. Mucormycosis. In: Jameson JL, Dennis L. Kasper,Longo DL, Fauci AS, Hauser SL, Loscalzo J, editors. Harrison’s Principles ofInternal Medicine, volume-1. 20th ed. NEW YORK: Mc-Grill Education; 2018. p.1546.
-
Lauren N C, Stefan M S. Fungal Diseases. In: Kang S, Amagai M,Bruckner AL, H. AE, Margolis DJ, McMichael AJ, et al., editors. Fitzpatrick’sDermatology Volume-I. 9th ed. NEW YORK: McGraw Hill Education; 2019. p. 2926 to2944.
-
Neena K. Illustrated Synopsis of Dermatology and SexuallyTransmitted Diseases. 4th ed. Delhi: Elsevier; 2011. 282–290 p.
-
de Hoog GS, Dukik K, Monod M, Packeu A, Stubbe D, Hendrickx M,et al. Toward a novel multilocus phylogenetic taxonomy for the dermatophytes.Mycopathologia. 2017;182(1–2):5–31.
-
Hay RJ, Ashbee HR. INFECTIONS ANDINFESTATION. In: Griffiths C,Barker J, Bleiker T, Robert C, Creamer & D, editors. ROOK’S TEXTBOOK OFDERMATOLOGY volume-1. 9TH ed. United Kingdom: Blackwell, Wiley; 2016. p.32.35-32.37.
-
Shenoy M, Jayaraman J. Epidemic of difficult-to-treat tinea inIndia: Current scenario, culprits, and curbing strategies. Arch Med Heal Sci.2019;7(1):112.
-
Varma S MR. The Great Indian Epidemic of Dematophytosis: AnAppraisal. Indian J Dermatol. 62(3):227-.
-
Abu al-Hasan Ali Ibni Abbas Mutib Majusi.KAMILUS SANA. New Dehli: Idara kitab Al-shifa; 2010. 432 p.
-
Hakim Muhammed Akbar Arzani. MEZANI ALTIB.NEW DELHI: Idara kitab Al-shifa; 2002. 249 p.
-
Sina SABAI. ALQANUN. 2nd ed. New Dehli:Idara kitab Al-shifa; 2014. 1431–1432 p.
-
Ahmad al-hasan al-jurjani. DHAKHIRAKHWARZAM SHAHI. New Dehli: Idara kitab Al-shifa; 2010. 24–26 p.
-
Hakeem Abd Alrahim Jaleel. MUJARRABATILUQMANI. Devband: A’jaz Publishing House; 116–119 p.
-
Hakeem Muhammad Kabir Aldeen. BAYAZI KABIR.New Dehli: Central Council for Reasearch in Unani Medicine; 2008. 214 p.
-
Sahoo AK, Mahajan R. Management of tineacorporis, tinea cruris, and tinea pedis: A comprehensive review. IndianDermatol Online J. 2016;7(2):77.
-
Neuhaus WJTBDEI. Andrews’ Diseases of theSkin. 12th Editi. Elsevier; 285–290 p.
-
M AAA bin MT. AlMUALAJATH ALBUQRATIYAVolume-2. New Dehli: Central Council for Reasearch in Unani Medicine; 1997.211–213 p.
-
Hakeem Kabiruddin. MUKHZAN ALMUFRADAT. NewDehli: A’jaz Publishing House; 590–591 p.
-
IBN B. ALJAMA ALMUFARADAT ALADVIA WAALAGHZIA VOL-4. New Dehli: Central Council for Reasearch in Unani Medicine;2003.
-
Narayan DP, S.S P, Arun KV, Tarun K. AHANDBOOK OF MEDICINAL PLANTS A COMPLETE SOURCE BOOK. Jodhpur: Agrobios (India);2013. 508 p.
-
Dutta BK, Rahman I, Das T. Antifungalactivity of Indian plant extracts Antimyzetische Aktivität indischerPflanzenextrakte. Mycoses. 1998;41(11/12):535–6.
-
Rubini B, Shanthi G, Rajarajan. S,Soundhari. C. Antifungal activity of Terminalia chebula and Terminalia catappaon two dermatophytes. J Med Aromat Plants. 2013;4(2):15-19:15–9.
-
Choudhary S V, Bisati S, Singh AL, Koley S.Efficacy and safety of terbinafine hydrochloride 1% cream vs. sertaconazolenitrate 2% cream in tinea corporis and tinea cruris: a comparative therapeutictrial. Indian J Dermatol. 2013;58(6):457.
-
Nepal A. Efficacy of topical terbinafineand clotrimazole in the treatment of dermatophytoses: a Clinical andMicrobiological Comparision. Med J Pokhara Acad Heal Sci. 2018;1(1):31–4.
-
Dattatreyo C, Sudip KG, Sukanta S, SaswatiS, Avijit H, Radharaman D. Efficacy and tolerability of topical sertaconazoleversus topical terbinafine in localized dermatophytosis:A randomisedobserver-blind,parallel group study. indian J Pharmacol. 2016;659–64.
-
Das A, Sil A, Sarkar TK, Sen A, ChakravortyS, Sengupta M, et al. A randomized, double-blind trial of amorolfine 0.25%cream and sertaconazole 2% cream in limited dermatophytosis. Indian JDermatology, Venereol Leprol. 2019;85(3):276.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •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%.
排除标准
- •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.
结局指标
主要结局
KOH examination
时间窗: At baseline and After completion of therapy
次要结局
- 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)
