SINGLE-BLIND, RANDOMIZED, CONTROL TRIAL OF A UNANI COMPOUND FORMULATION IN ILTEHAB TAJAWEEFE ANAF MUZMIN
Objective: The objective of the study was to establish the efficacy and tolerability of oral Unani formulations with inhalation of Kalonji and to provide safe, effective, and economical treatment for Iltehab Tajaweefe Anaf Muzmin (chronic rhinosinusitis [CRS]).
Methods: A randomized single-blind, comparative study of 40 patients of CRS. The patients were randomly allocated to two groups each consisting of 20 patients. In Group A, oral Unani formulation of Katan (Linum usitatissimum), Filfil Siyah (Piper nigrum), and honey was given 6 g BD with steam inhalation of Kalonji (Nigella sativa) and Tab Alaspan 1 BD with Karvol Plus inhalation was given in Group B.
Results: Statistical analysis of the data was done using paired t test by comparing the visual analog scale score of all major and minor symptoms before and after treatment. The result is statistically highly significant in Group A (p<0.0001) and it is significant in Group B. (p<0.01).
Conclusion: It may be concluded that the oral Unani formulation with inhalation of Kalonji has statistically highly significant effect on major and minor symptoms of CRS. A multicentric trial of the test drug on larger sample size for a longer duration is required to establish the efficacy of the formulation on CRS.
2. Yeolkar AM, Dasgupta KS, Khode S, Joshi D, Gosrani N, et al. A study of SNOT 22 scores in Adults with no Sinonasal disease. J Rhinolaryngootol 2013;1:6-10.
3. Kennedy DW, Kuhn FA, Hamilos DL, Zinreich SJ, Butler D, Warsi G, et al. Treatment of chronic rhinosinusitis with high-dose oral terbinafine: A double blind, placebo-controlled study. Laryngoscope 2005;115:1793-9.
4. Hopkins C, Brown JP, Slack R, Lund V, Topham J, Reeves B, et al. The national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope 2009;119:2459-65.
5. Ghazi-Moghadam K, Inancli HM, Bazazy N, Plinkert PK, Efferth T, Sertel S, et al. Phytomedicine in otorhinolaryn-gology and pulmonology: Clinical trials with herbal remedies. Pharmaceuticals (Basel) 2012;5:853-74.
6. Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, et al. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003;129 Suppl 3:S1-32.
7. Jurjani AH. In: Khan HH, editor. Zakhira Khwarizm Shahi. Vol. 2. Lucknow: Matba Munshi Naval Kishore; 1903. p. 205-6.
8. Al-Jawad FH, Al-Razzuqi RA, Hashim HM, Ahmed H. Broncho-relaxant activity of Nigella sativa versus Anthemis nobilis in chronic bronchial asthma; a comparative study of efficacy. IOSR J Pharm 2012;2:81-3.
9. Kabiruddin M. Moalejat; Sharah Asbab. 9th ed., Vol. 1. Hyderabad: Hikmat Book Depo; 1980. p. 15-20.
10. Naclerio RM. Xolair in Patients with Chronic Sinusitis. Chicago: US National Institute of Health, University of Chicago. Available from: https://www.clinicaltrials.gov/ct2/show/nct00117611.
11. Ferrara L, Naviglio D, Caruso AA. Cytological aspects on the effects of a nasal spray consisting of standardized extract of citrus lemon and essential oils in allergic rhinopathy. ISRN Pharm 2012;2012:404606.
12. Pratibha N, Saxena VS, Amit A, D’Souza P, Bagchi M, Bagchi D. Anti-inflammatory activities of aller-7, a novel polyherbal formulation for allergic rhinitis. Int J Tissue React 2004;26:43-51.
13. Multani HC. Tajul Aqaqeer. Vol. 2. Panipat, Haryana: Dr. Hari Chand Multani; ???. p. 803-4.
14. Elahi H, Masroorchehr MR, Nemati S, Kamalinejad M, Besharat M, Hajimehdipoor H, et al. Historical applications of Nigella sativa L. (Black cumin) in the treatment of Zokam and Nazleh in Persian Medicine. Res Hist Med 2014;3:11-20.
15. Peroni DG, Moser S, Gallo G, Pigozzi R, Tenero L, Zanoni L, et al. Ambroxol inhibits neutrophil respiratory burst activated by alpha chain integrin adhesion. Int J Immunopathol Pharmacol 2013;26:883-7.
16. Helms S, Miller A. Natural treatment of chronic rhinosinusitis. Altern Med Rev 2006;11:196-207.
17. Inouyea S, Takizawa T, Yamaguchi H. Antibacterial activity of essential oils and their major constituents against respiratory tract pathogens by gaseous contact. J Antimicrob Chemother 2001;47:565-73.
18. Hakeem A. Bustanul Mufredat. New Delhi: Zafar Book Depo; ???. p. 221.
19. Nikakhlagh S, Rahim F, Aryani FH, Syahpoush A, Brougerdnya MG, Saki N. Herbal treatment of allergic rhinitis: The use of Nigella sativa. Am J Otolaryngol 2011;32:402-7.
20. Alsamarai AM, Abdulsatar M, Alobaidi AH. Evaluation of topical black seed oil in the treatment of allergic rhinitis. Antiinflamm Antiallergy Agents Med Chem 2014;13:75-8.
21. Boskabady MH, Vahedi N, Amery S, Khakzad MR. The effect of Nigella sativa alone, and in combination with dexamethasone, on tracheal muscle responsiveness and lung inflammation in sulfur mustard exposed guinea pigs. J Ethnopharmacol 2011;137:1028-34.
22. Kirtikar KR, Basu BD. Indian Medicinal Plants. Vol. 1. Dehradun: International Book Distributors; 1987. p. 407-10.
23. Anonymous. Wealth of India. Vol. 6. New Delhi: CSIR; 1962. p. 119-40.
24. Bashir MU, Qureshi HJ. Analgesic effect of Nigella sativa seeds extract on experimentally induced pain in albino mice. J Coll Physicians Surg Pak 2010;20:464-7.
25. Lubhaya R. Goswami Bayanul Adviya. Vol. 1. New Delhi: Goswami Pharmacy; 1984. p. 101-2.
26. Baiytar I. Aljame Almufredat. Aladviya Wal Aghziya. Vol. 3. New Delhi: CCRUM; 2003. p. 377-9.
27. Sheikh BA. Alqanoon Fittib. Vol. 2. Lahore, Pakistan: Shiekh Mohd, Tahir & Sons; 2010. p. 62-3.
28. Haleem MA. Mufredat-E-Azizi. Lucknow: Sahitya Mandir Press; 1948. p. 10, 58.
29. Ghani NM. Khazaynul Adviya. Vol. 1. Lahore, Pakistan: Sheikh Bashir & Sons; 1920. p. 560-4.
30. Majdalawieh AF, Hmaidan R, Carr RI. Nigella sativa modulates splenocyte proliferation, Th1/Th2 cytokine profile, macrophage function and NK anti-tumor activity. Ethnopharmacol 2010;131:268-75.
31. Entok E, Ustuner MC, Ozbayer C, Tekin N, Yangi FA, Kurt H, et al. Anti-inflammatuar and anti-oxidative effects of Nigella sativa L.: 18FDG-PET imaging of inflammation. Mol Biol Rep 2014;41:2827-34.
32. Nakatani N, Inatani R, Ohta H, Nishioka A. Chemical constituents of peppers (Piper spp.) and application to food preservation: Naturally occurring antioxidative compounds. Environ Health Perspect 1986;67:135-42.
33. Vijayakumar RS, Surya D, Nalini N. Antioxidant efficacy of Black Pepper (Piper nigrum L.) and piperine in rats with high fat diet induced oxidative stress. Redox Rep 2004;9:105-10.
34. Kasote DN. Flaxseed phenolics as natural antioxidants. Int Food Res J 2013;20:27-34.
35. Ali M. Pharmacognosy. Vol. 1. New Delhi: CBS Publishers & Distributers Pvt. Ltd.; 2008. p. 408-11.
36. Singh MP, Panda H. Medicinal Herbs with their Formulations. Vol. 2. New Delhi: Daya Publications; 2005. p. 531-4.
37. Al-Snafi AE, Al-Samarai AG, Al-Sabawi AM. The therapeutic effect of Nigella sativa seed oil in treatment of chronic urticaria. Tikrit J Pharm Sci 2005;1:1-6.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.