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Therapeutic Evaluation of a Topical Unani Formulation, Tila-i Muhāsā in Buthūr Labaniyya (Acne Vulgaris): A Randomized, Controlled Clinical Study

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Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgarisMaterials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook’s acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.

Abstract

Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgarisMaterials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook’s acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.

참고문헌 (82)

  1. Abiya SE, "Antimicrobial activity of three medicinal plants against acne-inducing bacteria Propionibacterium acnes", Brazilian Journal of Biological Sciences, 5(10), pp.277~288 (2018)
  2. Abriham H, "In vitro Antioxidant and Antibacterial Activity of Albizia lebbeck(L) Benth Stem Bark", Sci. Technol. Arts Res. J., 4(2), pp.204~206 (2015)
  3. Aditi G, "Antimicrobial activity of medicinal plants Azadirachta indicaA. Juss, Allium cepaL. and Aloe veraL", Int. J Pharm Tech Res, 3(2), pp.1059~1065 (2011)
  4. Adityan B, "Scoring systems in acne vulgaris", Indian J Dermatol Venereol Leprol, 75(3), pp.323~326 (2009)
  5. Ali MT, "A comparative study of in vitroantimicrobial, antioxidant and cytotoxicactivity of Albizia lebbeckand Acacianiloticastem bark", Bulletin of Faculty of Pharmacy, Cairo University, 56, pp.34~38 (2018)
  6. Ali SS, "Unani Adviya Mufarrada", pp.275~276 (2010), National Council for Promotion of Urdu Language, Ministry of HRD
  7. Anonymous, "Standardization of Single Drugs of Unani Medicine, Vol-1,2,3,4", pp.42~46 (1987), CCRUM, Ministry of Health and Family
  8. Anonymous, "The Unani Pharmacopoeia of India, Part-I, Vol.-2", pp.2007, Dept. of AYUSH, M
  9. Anonymous, "The Unani Pharmacopoeia of India, Part-I, Vol.-4", pp.2007, Dept. of AYUSH, M
  10. Anonymous, "Standard Unani Medical Terminology", pp.303~ (2012), CCRUM, Dept. of AYUSH
  11. Anṭākī D., "Tadhkira Ūlī al-Albāb", pp.87~ (2010), CCRUM, Ministry of Health & Family Welfare
  12. Arzāni HMA, "Ṭibb-i Akbar", pp.697~, Faisal Publications
  13. Arzānī HMA, "Mīzān al-Tibb", pp.249~ (2001), Idārā Kitāb al-Shifā
  14. Babu NP, "Anti-inflammatory activity of Albizia lebbeckBenth., an ethnomedicinal plant, in acute and chronic animal models of inflammation", Journal of Ethnopharmacology, 125, pp.356~360 (2009)
  15. Baghdādī IH, "Kitāb al-Mukhtārāt fiʼl Ṭibb, Vol. 4", pp.188~189, CCRUM, Dept. of AYUSH, Ministry of Health & Family Welfare
  16. Balakrishnan KP, "Antibacterial activity of certain medicinal plants against acne inducing bacteria", Int J Pharma Bio Sci, 2(3), pp.476~481 (2011)
  17. Barnes LE, "Quality of life measures for acne patients", Dermatologic Clinics, 30(2), pp.293~300 (2012)
  18. Barua CC, "Evaluation of the wound healing activity of methanolic extract of Azadirachta indica(Neem)and Tinosporacordifolia(Guduchi)in rats", Pharmacologyonline, 1, pp.70~77 (2010)
  19. BasakPY, "The role of the antioxidative defense system in papulopustular acne", J Dermatol, 28(3), pp.123~127 (2001)
  20. Benisheikh AAG, "Phytochemical Extraction and Antimicrobial Studies on CrudeLeaf Extract of Azadirachta indica(Neem)in Semi-Arid Region of Borno State, Nigeria", International Journal of Research & Review, 6(12), pp.516~522 (2019)
  21. Bolognia JL, "Dermatology, Vol. 1", pp.588~603 (2018), Elsevier Limited
  22. Bowe WP, "Acne vulgaris : the role of oxidative stress and the potential therapeutic value of local and systemic antioxidants", JDrugsDermatol, 11(6), pp.742~746 (2012)
  23. Chattopadhyay RR, "Possible mechanism of anti-inflammatory activity ofAzadirachta indicaleaf extract", Indian J. Pharmacol., 25, pp.99~100 (1993)
  24. Chattopadhyay RR, "Possible biochemical mode of anti-inflammatory action of Azadirachtaindica A. Juss in rats", Indian Journal of Experimental Biology, 36(4), pp.418~420 (1998)
  25. Chaudhary M, "Comparative Immunomodulator Activity of Leaves and Bark of Albizia lebbeck(Linn.) Benth", Int. J. Res. Dev. Pharm. L. Sci, 1(1), pp.25~27 (2012)
  26. Chulet R, "Phytochemical screening and antimicrobial activity of Albizia lebbeck", J. Chem. Pharm. Res, 2(5), pp.476~484 (2010)
  27. CookCH, "An Acne Grading Method Using Photographic Standards", Archives of Dermatology, 115(5), pp.571~575 (1979)
  28. Das AK, "Anti-inflammatory effect of Albizzia lebbeck(Benth.) Bark", Online Journal of Biological Science, 3, pp.685~687 (2003)
  29. Dinda A, "Analgesic and anti-inflammatory activity of hydro-alcoholic extract of Azadirachta indicaLeaf", Pharmacologyonline, 3, pp.477~484 (2011)
  30. Doshi A, "A comparison of current acne grading systems and proposal of a novel system", International Journal of Dermatology, 36(6), pp.416~418 (1997)
  31. Durrani FR, "Immunomodulatory and growth promoting effects of Neem leaves infusion in broiler chicks", Sarhad J. Agric, 24, pp.655~659 (2008)
  32. Ganaie AA, "Antioxidant activity of some extracts of Iris ensata", J Pharmacogn Phytochem, 7(2), pp.230~235 (2018)
  33. Ganguli NB, "Mode of Action of active principles from stem bark of Albizialebbeck", Indian J Experiment Biol, 31, pp.125~129 (1993)
  34. Ghani N, "Khazāin al Adviā", pp.242~243 (2010), Idāra Kitāb al-Shifā
  35. Ghimeray AK, "Antioxidant activity and quantitative estimation of azadirachtin and nimbin inAzadirachta indicaA. Juss grown in foothills of Nepal", Afr. J. Biotechnol, 8(13), pp.3084~3091 (2009)
  36. Ghonmode WN, "Comparison of the antibacterial efficiency of Neem leaf extracts, grape seed extracts and 3% sodium hypochlorite against E. feacalis-an in vitrostudy", J IntOral Health, 5(6), pp.61~66 (2013)
  37. Goldsmith LA, "Fitzpatrick’s Dermatology in General Medicine", pp.897~917 (2012), McGraw-Hill Companies
  38. Goodman G, "Acne and Acne Scarring -the case for active and early intervention", Australian Family Physician, 35(7), pp.503~504 (2006)
  39. Goodman GJ, "Post-acne scarring: A short review of its pathophysiology", Australas. J. Dermatol, 42, pp.84~90 (2001)
  40. GrangePA, "ProductionofSuperoxideAnionsbyKeratinocytesinitiatesP.acnes-inducedInflammationoftheSkin", PLoSPathogens, 5(7), pp.1~14 (2009)
  41. Griffiths C, "Rook’s Textbook of Dermatology", pp.90~ (2016), John Wiley & Sons, Ltd
  42. Hakīm MA, "Bustān al Mufradāt Jadīd", pp.85~ (2002), Idāra Kitāb al-Shifā
  43. Ibn Sīnā, "Al Qānūn fi’l Ṭibb", pp.1420~ (2010), Idāra Kitāb al-Shifā
  44. Ingham E, "The immunology of Propionibacterium acnesand acne", Curr Opin Infect Dis, 12(3), pp.191~197 (1999)
  45. Jain A, "Inhibition of Propionibacterium acnes-induced mediators of inflammation by Indian herbs", Phytomedicine, 10(1), pp.34~38 (2003)
  46. Kabīruddīn HM, "Bayāḍ-i Kabīr, Vol. 2", pp.126~ (1977), Shaukat Book Depot
  47. Kamlesh JW, "Formulation and Evaluation of Cream of Azadirachta indicaleaves extracts on Skin Renewal rate", Int. J. ChemTech Res, 1(1), pp.88~95 (2009)
  48. Kaur G, "Nimbidin suppresses functions of macrophages and neutrophils : relevance to its anti-inflammatory mechanisms", Phytotherapy Research, 18(5), pp.419~424 (2004)
  49. Khare CP, "Indian Medicinal Plants -An Illustrated Dictionary", pp.30~ (2007), Springer Verlag
  50. Mahfuzul Hoque MD, "Antibacterial activity of guava (Psidium guajavaL.) and neem (Azadirachta indicaA. Juss.) extracts against foodborne pathogens and spoilage bacteria", Foodborne Pathog Dis, 4(4), pp.481~488 (2007)
  51. Maragathavalli S, "Antimicrobial activity in leaf extract of Neem (Azadirachta indicaLinn.)", Int. J.Sci. Nat., 3, pp.110~113 (2012)
  52. Mosaddek ASM, "A comparative study of the anti-inflammatory effect of aqueous extract of Neem leaf and dexamethasone", BangladeshJ. Pharmacol, 3(1), pp.44~47 (2008)
  53. Osunwoke EA, "The wound healing effects of aqueous leave extracts of Azadirachta indicaon wistar rats", J. Nat. Sci. Res, 3(6), pp.181~186 (2013)
  54. Papadakis MA, "Current Medical Diagnosis & Treatment", pp.134~136 (2019), McGraw-Hill Education
  55. Patel P, "In-vitro antioxidant activity of Azadirachta indicaleaves", J Advances Pharmacy Healthcare Res, 1(3), pp.22~27 (2011)
  56. Patterson JW, "Weedon’s Skin Pathology", pp.459~461 (2016), Churchill Livingstone, Elsevier Ltd
  57. Pramanik K., "Anti-inflammatory activity of methanol extract of Albizzia lebbeck(Mimosaceae)bark", Eur Bulletin Drug Res, 13, pp.71~75 (2005)
  58. Ralston SH, "Davidson’s Principles and Practice of Medicine", pp.1241~1243 (2018), Elsevier Ltd
  59. Rashid RB, "Constituents of Albizia lebbeckand antibacterial activity of an isolated flavone derivatives", Saudi Pharm. J, 11(1-2), pp.52~56 (2003)
  60. Ray A, "Modulation of humoral and cell-mediated immune responses by Azadirachta indica(Neem)in mice", Indian J Exp Biol, 34(7), pp.698~701 (1996)
  61. Rāzī ABMZ, "Kitāb al-Ḥāwifi’l Tibb. Vol. 23", pp.36~37 (1994), Saba Publishers
  62. Renu S, "Effect of Neem (Azadirachta indica) leaf extract administration on immune responses of broiler chickens", J. Immunol. Immunopathol, 5, pp.47~50 (2003)
  63. Sadekar RD, "Immunopotentiating effects ofAzadirachtaindica(Neem) dry leaves powder in broilers, naturally infected with IBD virus", Ind J Exp Biol., 36(11), pp.1151~1153 (1998)
  64. Saha A, "The analgesic and anti-inflammatory activities of the extract of Albizia lebbeckin animal model", Pak. J. Pharm. Sci, 22(1), pp.74~77 (2009)
  65. Salem MZM, "Biological activity of extracts from Morus albaL., Albizzia lebbeck(L.) Benth. and Casuarina glaucaSieber against the Growth of some Pathogenic Bacteria", Int J Agri Food Res, 2(1), pp.9~22 (2013)
  66. Sarmiento WC, "An in vitro study on the antibacterial effect of Neem(Azadirachta indica)leaf extracts on methicillin-sensitive and methicillin-resistantStaphylococcus aureus", PIDSP Journal, 12(1), pp.40~45 (2011)
  67. Schumacher M, "Anti-inflammatory, pro-apoptotic, and anti-proliferative effects of a methanolic neem(Azadirachta indica)leaf extract are mediated via modulation of the nuclear factor-κB pathway", Genes and Nutrition, 6(2), pp.149~160 (2011)
  68. Sehgal VN, "Textbook of Clinical Dermatology", pp.12~16 (2011), Jaypee Brothers Medical Publishers
  69. Sīnā I, "Al-Qānūn fi’l Ṭibb, Urdu Translation by Ḥakīm Ghulām Ḥasnayn Kintūrī.Vol. IV", pp.1420~ (2010), Idāra Kitāb al-Shifā
  70. Sithisarn P, "Antioxidant activity of siamese neem tree", J Ethnopharmacol, 99(1), pp.109~112 (2005)
  71. Suruse PB, "In-VitroEvaluation of Antioxidant Activity of Albizia lebbeckBark", Int. J. Biol. Sci. Ayur. Res, 1(1), pp.6~17 (2013)
  72. Tasnim J, "Biological Studies of the Bark of Albizia Lebbeck(L.) Benth", Int J. Pharm Sci Res, 5(11), pp.4969~4974 (2014)
  73. Upadhyay SN, "Immunomodulatory effects of Neem (Azadirachta indica) oil", Int. J. Immunopharmacol, 14(7), pp.1187~1193 (1992)
  74. van der Nat JM, "Immunomodulatory activity of an aqueous extract ofAzadirachta indicastem bark", J Ethnopharmacol, 19(2), pp.125~131 (1987)
  75. Vos T, "Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015", Lancet, 388(10053), pp.1545~1602 (2016)
  76. Wadher KJ, "Skin renewal effect of different extracts of leaves of Azadirachta indica", Int. J. PharmTech Res, 1(4), pp.1350~1353 (2009)
  77. Wagay JI, "Phytochemical Analysis and Antimicrobial Activity of Iris kashmiriana and Iris ensata Extracts against Selected Microorganisms", J Drug Delivery & Therapeutics, 8(6), pp.28~34 (2018)
  78. WilliamsHC, "Acnevulgaris", Lancet, 379(9813), pp.361~372 (2012)
  79. Wolff K, "Fitzpatrick’s Color Atlas and Synopsis of Clinical Dermatology", pp.2~7 (2013), McGraw-Hill Education
  80. Yerima MB, "Effect of Neem extracts (Azadirachta indica) on bacteria isolated from adult mouth", J.Basic&Appl.Sci, 20, pp.64~67 (2012)
  81. Zeind CS, "Applied Therapeutics: the clinical use of drugs", pp.824~831 (2018), Wolters Kluwer Health
  82. Zia-Ul-Haq M, "Compositional studies and antioxidant potential of Albizia lebbeck(L.) Benth. pods and seeds", Turk J. Biol, 37, pp.25~32 (2013)

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