Evaluation of the efficacy of topical Terminalia chebula Retz. with vinegar in the treatment of tinea corporis: a non-inferiority randomized controlled trial
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Sumayya Tasneem Parapur
,
Mohd Khalid
,
Saba Abdul Razzaq Mamdapur
Abstract
Objectives
Unani physicians have suggested a wide range of anti-dermatophytic remedies, although the scientific evidence is scarce. Thus, the efficacy and safety of Terminalia chebula Retz. fruit powder mixed with vinegar was compared with terbinafine hydrochloride 1% cream in the treatment of tinea corporis in order to establish the non-inferiority of test drugs.
Methods
The primary outcome measures were change in the presence or absence of hyphae on KOH mount test, change in pruritus severity assessed on 100 mm VAS and change in physician’s global assessment. Secondary outcome measure was change in the dermatology life quality index (DLQI). Hemograms, serum creatinine, serum bilirubin, and random blood sugar levels were measured at the baseline and after treatment to ensure the safety of the interventions.
Results
A per-protocol analysis was done on 40 participants (21 in the test group and 19 in the control group). The observed differences in the primary and secondary outcomes between the test and control groups were greater than the non-inferiority margin, signifying that the test drugs were not inferior.
Conclusions
It may be inferred that the trial drug Terminalia chebula Retz. fruit powder mixed with vinegar is not inferior to terbinafine hydrochloride cream in the treatment of tinea corporis.
Acknowledgments
The authors would like to express their heartfelt appreciation to Dr. Mohd. Aqil Quadri (Dean), Dr. Shehnaz Banu (Principal), Dr. Tasmiya Indikar (Vice-principal), and Dr. Nuzhat Patel, Dr. Meenu Doni, Dr. Mohammad Iliyas Patel and Dr. Aaftab M Nadaf of Luqman Unani Medical College Hospital and Research Center, Bijapur, Karnataka, as well as to all the patients who participated in this study for their cooperation in conducting the trial.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: This research complied with all the applicable national and institutional regulations, as well as the precepts of the Helsinki Declaration (as revised in 2013) and was approved by the Institutional Ethics Committee of Luqman Unani Medical College with the protocol number (BJP/LUMC/PG/IEC/04/2019-20/MOALIJAT/01) and prospectively registered on Clinical Trial Registry of India (CTRI) with CTRI number CTRI/2021/01/030404.
References
1. Kim, BY, Thomas, JL. Approach to the patient with a skin disorder. In: Jameson, JL, Kasper, DL, Longo, DL, Fauci, AS, Hauser, SL, Loscalzo, J, editors. Harrison’s principles internal medicine, 20th ed. New York: Mc-Grill Education; 2018:335–6 pp.Search in Google Scholar
2. Henry, WL. Eczemas, photodermatoses, papulosquamous (including fungal) diseases, and figurate erythemas. In: Lee, G, Andrew, S, editors. Goldman-cecil medicine, 24th ed. New York: Elsevier; 2012, vol II:2521 p.Search in Google Scholar
3. Sahoo, AK, Mahajan, R. Management of tinea corporis, tinea cruris, and tinea pedis: a comprehensive review. Indian Dermatol Online J 2016;7:77. https://doi.org/10.4103/2229-5178.178099.Search in Google Scholar PubMed PubMed Central
4. Khanna, N. Illustrated synopsis of dermatology and sexually transmitted diseases, 4th ed. Delhi: Elsevier; 2011:282–90 pp.Search in Google Scholar
5. Carol, AK. Mucormycosis. In: Jameson, JL, Kasper, DL, Longo, DL, Fauci, AS, Hauser, SL, Loscalzo, J, editors. Harrison’s principles of internal medicine, 20th ed. New York: Mc-Grill Education; 2018:1546 p.Search in Google Scholar
6. Lauren, NC, Stefan, MS. Fungal diseases. In: Kang, S, Amagai, M, Bruckner, AL, H. AE, Margolis, DJ, McMichael, AJ, et al.. editors. Fitzpatrick’s Dermatology, 9th ed. New York: McGraw Hill Education; 2019:2926–44 pp.Search in Google Scholar
7. Hay, RJ, Ashbee, HR. Infections and infestation. In: Griffiths, C, Barker, J, Bleiker, T, Robert, C, Creamer, D, editors. Rook’s textbook of dermatology, 9th ed. United Kingdom: Blackwell, Wiley; 2016, vol I:32.35–7 pp.Search in Google Scholar
8. Shenoy, M, Jayaraman, J. Epidemic of difficult-to-treat tinea in India: current scenario, culprits, and curbing strategies. Arch Med Heal Sci 2019;7:112. https://doi.org/10.4103/amhs.amhs_72_19.Search in Google Scholar
9. Varma, SMR, Madhu, R. The great indian epidemic of dematophytosis: an appraisal. Indian J Dermatol 2017;62:227–36. https://doi.org/10.4103/ijd.IJD_206_17.Search in Google Scholar PubMed PubMed Central
10. Majusi, AA. Kamil al-sana. New Delhi: Idara kitab al-shifa; 2010:432 p.Search in Google Scholar
11. Arzani, MA. Meezan al-tibb. New Delhi: Idara kitab al-shifa; 2002:249 p.Search in Google Scholar
12. Sina, I. Alqanoon, 2nd ed. New Delhi: Idara kitab al-shifa; 2014:1431–2 pp.Search in Google Scholar
13. Jurjani, AH. Dhakhira khwarizm shahi. New Dehli: Idara kitab al-shifa; 2010: 24–6 pp.Search in Google Scholar
14. Ghani, N. Khazain al-adwiya. New Delhi: Idara kitab al shifa; 2007:1352–4 pp.Search in Google Scholar
15. Naseem, S, Nawab, M, Fatima, SH, Minhajuddin, A, Khan, AA. Assessing the efficacy and safety of unani pharmacopoeial formulations in dermatophytosis (quba) – a randomized controlled trial. Drug Metab Pers Ther 2023;38:169–77. https://doi.org/10.1515/dmpt-2022-0125.Search in Google Scholar PubMed
16. Balfour, JA, Faulds, D. Terbinafine. Drugs 1992;43:259–84. https://doi.org/10.2165/00003495-199243020-00010.Search in Google Scholar PubMed
17. Ryder, NS. Terbinafine: mode of action and properties of the squalene epoxidase inhibition. Br J Dermatol 1992;126:2–7. https://doi.org/10.1111/j.1365-2133.1992.tb00001.x.Search in Google Scholar PubMed
18. Bhatia, A, Kanish, B, Badyal, DK, Kate, P, Choudhary, S. Efficacy of oral terbinafine versus itraconazole in treatment of dermatophytic infection of skin – a prospective, randomized comparative study. Indian J Pharmacol 2019;51:116–9. https://doi.org/10.4103/ijp.IJP_578_17.Search in Google Scholar PubMed PubMed Central
19. Chow, SC, Shao, J, Wang, H, Lokhnygina, Y. A CRC Title, Part of the Taylor & Francis Imprint, a member of the Taylor & Francis Group, the Academic Division of T&F Informa Plc. In: Sample size calculations in clinical research, Chapman & Hall/CRC biostatistics series, 3rd ed. Boca Raton: Taylor & Francis, Chapman and Hall/CRC; 2017, vol 10–11:77–80 pp.Search in Google Scholar
20. Dworkin, RH, Turk, DC, Wyrwich, KW, Beaton, D, Cleeland, CS, Farrar, JT, et al.. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: immpact recommendations. J Pain 2008;9:105–21. https://doi.org/10.1016/j.jpain.2007.09.005.Search in Google Scholar PubMed
21. Kim, ST, Jun, JB, Suh, SB. Clinical and mycological observations on tinea corporis. Korean J Dermatol 1982;20:703–12.Search in Google Scholar
22. Banerjee, M, Ghosh, AK, Basak, S, Das, KD, Gangopadhyay, DN. Comparative evaluation of effectivity and safety of topical amorolfine and clotrimazole in the treatment of tinea corporis. Indian J Dermatol 2011;56:657–62. https://doi.org/10.4103/0019-5154.91823.Search in Google Scholar PubMed PubMed Central
23. Leung, AK, Lam, JM, Leong, KF, Hon, KL. Tinea corporis: an updated review. Drugs Context 2020;9:1–12. https://doi.org/10.7573/dic.2020-5-6.Search in Google Scholar PubMed PubMed Central
24. Penmetcha, U, Myneni, RB, Yarlagadda, P, Simgamsetty, S. A study of prevalence of dermatophytosis in and around guntur district, Andhra Pradesh, south India. Int J Curr Microbiol App Sci 2016;5:702–17. https://doi.org/10.20546/ijcmas.2016.509.081.Search in Google Scholar
25. Aaliya, NM, Kazmi, MH, Ayyub, S. A randomized active controlled clinical trial to evaluate safety and efficacy of a topical unani formulation marham kharish jadeed in the management of qūbā (tinea corporis). Cell Med 2020;10:1–7. https://doi.org/10.5667/CellMed.2020.0022.Search in Google Scholar
26. Mangala, GK, Chandrappa, NR. Epidemiological study of dermatophytosis in and around davanagere. Indian J Public Heal Res Dev 2013;4:112. https://doi.org/10.5958/j.0976-5506.4.4.153.Search in Google Scholar
27. Mohanty, JC, Mohanty, SK, Sahoo, RC, Sahoo, A, Praharaj, CN. Incidence of dermatophytosis in Orissa. Indian J Med Microbiol 1998;16:78–80.Search in Google Scholar
28. Prajapati, ND, Purohit, SS, Sharma, SS, Kumar, T. A handbook of medicinal plants (a complete source book). Jodhpur, India: Agrobios; 2003:508 p.Search in Google Scholar
29. Dutta, BK, Rahman, I, Das, T. Antifungal activity of indian plant extracts antimyzetische aktivität indischer pflanzenextrakte. Mycoses 1998;41:535–6. https://doi.org/10.1111/j.1439-0507.1998.tb00718.x.Search in Google Scholar PubMed
30. Rubini, B, Shanthi, G, Rajarajan, S, Soundhari, C. Antifungal activity of terminalia chebula and terminalia catappa on two dermatophytes. J Med Aromat Plants 2013;4:15–9.Search in Google Scholar
31. Nigam, M, Mishra, AP, Adhikari-Devkota, A, Dirar, AI, Hassan, MM, Adhikari, A, et al.. Fruits of terminalia chebula retz.: a review on traditional uses, bioactive chemical constituents and pharmacological activities. Phyther Res 2020;34:2518–33. https://doi.org/10.1002/ptr.6702.Search in Google Scholar PubMed
32. Venkatachalam, P, Chittibabu, CV. Antifungal activity of terminalia chebula fruit extracts. Curr Bot 2020;11:216–20. https://doi.org/10.25081/cb.2020.v11.6499.Search in Google Scholar
33. Saleem, MN, Idris, M. Sirka (vinegar): from traditional use to the scientific approach. J Herb Med Res 2016;1:32–9.Search in Google Scholar
34. Samad, A, Azlan, A, Ismail, A. Therapeutic effects of vinegar: a review. Curr Opin Food Sci 2016;8:56–61. https://doi.org/10.1016/j.cofs.2016.03.001.Search in Google Scholar
© 2023 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Relevance of personalized medicine for improving traditional medicine
- Review
- Mechanistic role and potential of Ayurvedic herbs as anti-aging therapies
- Original Articles
- Safety, immunogenecity and effectiveness of ChAdOx1 nCoV-19 vaccine during the second wave of pandemic in India: a real-world study
- Evaluation of the efficacy of topical Terminalia chebula Retz. with vinegar in the treatment of tinea corporis: a non-inferiority randomized controlled trial
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Articles in the same Issue
- Frontmatter
- Editorial
- Relevance of personalized medicine for improving traditional medicine
- Review
- Mechanistic role and potential of Ayurvedic herbs as anti-aging therapies
- Original Articles
- Safety, immunogenecity and effectiveness of ChAdOx1 nCoV-19 vaccine during the second wave of pandemic in India: a real-world study
- Evaluation of the efficacy of topical Terminalia chebula Retz. with vinegar in the treatment of tinea corporis: a non-inferiority randomized controlled trial
- Pharmacogenetic predictors of development of secondary to enalapril dry cough in hypertensive patients
- Genetic markers associated with adverse reactions of radioiodine therapy in thyroid cancer patients
- Lack of exposure to pharmacogenomics education among the health care providing students in the West Bank of Palestine
- Development and validation wise assessment of genotype guided warfarin dosing algorithm in Indian population
- Exploratory quasi-experimental study of anti-arthritic activity of Ayurvedic polyherbal formulation, Abha Guggulu in osteoarthritis patients
- Letter to the Editor
- Ayurvedic medicines in alleviating the symptoms of SARS-CoV-2 omicron variant in North Indian population: a regional genomic study
