Clinical evaluation of a topical Unani pharmacopoeial formulation Tila-e-Kalf in the management of melasma (Kalf): A randomized controlled clinical trial | ||
Avicenna Journal of Phytomedicine | ||
دوره 13، شماره 3، مرداد و شهریور 2023، صفحه 255-264 اصل مقاله (775.52 K) | ||
نوع مقاله: Original Research Article | ||
شناسه دیجیتال (DOI): 10.22038/ajp.2022.21346 | ||
نویسندگان | ||
Salma Chaudhary1؛ Yasmeen Shamsi1؛ Sadia Nikhat2؛ Mukesh Manjhi3؛ Md. Wasi Akhtar* 4؛ Sayeed Ahmad5 | ||
1Department of Moalajat, SUMER, Jamia Hamdard, New Delhi, India | ||
2Department of Ilaj Bil Tadbeer, SUMER, Jamia Hamdard, New Delhi, India | ||
3Department of Dermatology, HIMSR, Jamia Hamdard, New Delhi, India | ||
4Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi, India | ||
5Department of Pharmacognosy, SPER, Jamia Hamdard, New Delhi, India | ||
چکیده | ||
Objective: Melasma is a chronic, acquired, symmetrical hyper melanosis of skin, characterized by irregular light to dark brown patches on sun-exposed areas, with a significant effect on psychological health; melasma is termed as Kalf in Unani medicine. Conventional treatments have transitory results and often carry adverse effects like skin irritation, scarring, etc. This study was planned to evaluate the safety and efficacy of a Unani pharmacopoeial formulation Tila-e-Kalf, comprising of lentil (Lens culinaris), bitter almond (Prunus amygdalus), and fig (Ficus carica), and to compare its efficacy with standard drug hydroquinone in patients of melasma. Materials and Methods: This was an 8-week open-label, standard controlled, randomized clinical study conducted on patients of epidermal melasma. The test group received Tila-e-Kalf while the control group received hydroquinone 4% cream for local application once daily. Efficacy was assessed by MASI (Melasma Area Severity Index), DLQI (Dermatology Life Quality Index), and PGA (Physician Global Assessment) and colored photographs. Results: Mean MASI score decreased from10.65±0.85 to 7.07±0.74 in the test group (p<0.0001) and from 11.28±1.24 to 7.76±0.9 (p<0.0001) the in control group. Similar improvement was noticed in other parameters also. A large number of patients in the control group reported mild burning, itching, dryness, and skin rashes, while only one patient in the test group reported mild itching. Conclusion: Tila-e-Kalf as a topical depigmenting agent was found equally effective with better tolerability and safety as compared to hydroquinone. | ||
کلیدواژهها | ||
Chloasma؛ Hyperpigmentation؛ Topical treatment؛ Unani medicine؛ Hydroquinone | ||
مراجع | ||
Aggarwal K, Puri V, Goel RK, Verma D. 2016. An unusual case of facial hyperpigmentation solved on histopathology. J Clin Diagnostic Res, 10: WL01-WL02. Khan H, Akhtar N, Ali A. 2014. Effects of cream containing ficus carica L. fruit extract on skin parameters: in vivo evaluation. Indian J Pharm Sci, 76: 560- 564. Ali B, Mujeeb M, Aeria V, Mir SR, Faiyazuddin M, Shakeel F. 2012. Antiinflammatory and antioxidant activity of Ficu scarica Linn. Nat Prod Res, 26: 460- 465. Baitar I. 1999. Adas. in „Al Jame' al-Mufradat Al Aghzia wal Advia. Vol. 3, p. 242, New Delhi, Central Council for Research in Unani Medicine. Ball Arefiev KL, Hantash BM. 2012. Advances in the treatment of melasma: a review of the recent literature. Dermatol Surg, 38: 971-984. Dereure O. 2001. Drug-induced skin pigmentation. epidemiology, diagnosis and treatment. Am J Clin Dermatol, 2: 253-262. Finlay AY, Khan G. 1994. Dermatology life quality index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol, 19: 210-216. Gupta AK, Grover MD, Nouri K, Taylor S. 2006. The treatment of melasma: A review of clinical trials. J Am Acad Dermatol, 55: 1048-1065. Handel AC, Miot LD, Miot HA. 2014. Melasma: a clinical and epidemiological review. An Bras Dermatol, 89: 771-782. Harumi O, Goh CL. 2016. The Effect of melasma on the quality of life in a sample of women living in Singapore. J Clin Aesthet Dermatol, 9: 21-24. Jagannathan M, Sadagopan K, Ekkarakudy J, Anandan H. 2017. Clinicoepidemiological study of patients with melasma in a tertiary care hospital - a prospective study. Int J Sci Study, 4: 117- 120. Jain DS, Balachandrudu DB. 2018. A clinical study of melasma of face in women and comparison of different treatment modalities of melasma (glycolic acid - 35% and tca 15% peels). Indian J Appl Res, 8: 39-41. Kabiruddin M. 1951. MakhzanulMufradat, KhawasulAdvia, Vol. I, pp.111, 543-544, Lahore, Sheikh Mohammad Bashir & Sons. Kabiruddin M. 1969.TarjumaSharahAsbab, Vol. 3, pp 344-346, New Delhi, Aijaz Publishing House. Kabiruddin M. 2006. Al-Qarabadeen,2nd ed., p.408, New Delhi, Central Council for Research in Unani Medicine. Khan MA. 2006. Rumooz-e-Azam, Vol. 2, p. 104, New Delhi, Central Council for Research in Unani Medicine. Khan MA. 2012. Muheet-e-Azam, Vol. 1, pp. 452-457, New Delhi, Central Council for Research in Unani Medicine. Salma et al. AJP, Vol. 13, No. 3, May-Jun 2023 264 Khan MA. 2014. Muheet e Azam,Vol. 3, pp. 553-554, New Delhi, Central Council for Research in Unani Medicine. Khosravan S, Alami A, Moghadam, HM. 2017. The effect of topical use of petroselinum crispum (parsley) versus that of hydroquinone cream on reduction of epidermal melasma. Holist Nurs Prac, 31: 16-20. Kimbrough-Green CK, Griffiths CE, Finkel LJ, Hamilton TA, Bulengo-Ransby SM, Ellis CN, Voorhees JJ. 1994. Topical retinoic acid (tretinoin) for melasma in black patients: a vehicle-controlled clinical trial. Arch Dermatol, 130: 727- 733. Khosravan S, Alami A, MohammadzadehMoghadam H, Ramezani V, Sheikhnavesi M, 2015. The efficacy of topical use of petroselinum crispum (parsley) versus hydroquinone cream for reduction of epidermal melasma: a randomized clinical trial. Avicenna J Phytomed, 5(Supplement): 126-127. Kroon MW, Wind BS, Beek JF, Veen JW. 2011. Nonablative 1550-nm fractional laser therapy versus. J Am Acad Dermatol, 64: 517-523. Moradi B, Soureshjani SH, Samani MA, Yang Q. 2017. A systematic review of phytochemical and phytotherapeutic characteristics of bitter almond. In J Pharm Phytopharmacological Res, 7: 1-9. Niwa MA, Eimpunth S, Fabi SG, Guiha I, Groff W, Fitzpatrick R. 2013. Treatment of melasma with the 1,927‐nm fractional thulium fiber laser: A retrospective analysis of 20 cases with long‐term. Lasers Surg Med, 45: 95-101. Razi Z. 1986. Kitabul Mansoori, pp. 198-199, New Delhi, Central Council for Research in Unani Medicine. Sadeghpour M, Dover JS, Rohrer TE. 2018. Advances in the treatment of melasma: an evidence-based approach. Adv Cosmet Surg, 1: 163-174. Sarkar R, Arora P, Sonthalia S, Gokhale N. 2014. Melasma update. Indian Dermatol Online J, 5: 426-435. Shah JS, Patel NK, Detholia KK, Patel SK, Varia UR. 2018. Melasma: A recurrent hyperpigmentory disorder. Int J Curr Res Pharm, 2: 29-36. Sina I. 1992. Al Qanoon Fil Tibb, Vol. 4, pp. 349-351, Lahore, Sheikh Mohammad Bashir and Sons. Yang SH, Tsatsakis AM. Tzanakakis G. Kim H-S, Le B, Sifaki M, Spandidos DA, Tsukamoto Ch, Golokhvast KS, Izotov BN, Chung G. 2017. Soyasaponin Ag inhibits α MSH induced melanogenesis in B16F10 melanoma cells via the downregulation of TRP 2. Int J Mol Med, 40: 631-636. Zubair S, Mujtaba G. 2009. Comparison of efficacy of topical 2% liquiritin, topical 4% liquiritin and topical 4% hydroquinone in the management of melasma. J Pakistan Assoc Dermatologists, 19: 158-163. | ||
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