SINGLE BLIND, RANDOMISED, CONTROL TRIAL OF A UNANI COMPOUND FORMULATION IN ILTEHAB TAJAWEEFE ANAF MUZMIN

  • Zehra Khatoon Zaidi Jamia Hamdard,New Delhi
  • ASIM ALI KHAN
  • AZHAR JABEEN

Abstract

Objective To establish the efficacy and tolerability of Unani formulations both oral as well as inhalation of Kalonji. To provide safe, effective and economical treatment for Iltehab Tajaweefe Anaf Muzmin (Chronic Rhinosinusitis)


 


Methods A randomized single blind, controlled study of forty patients of CRS. The patients were randomly allocated to two groups each consisting of 20 patients. In Group A, Unani oral formulation of Katan (Linum usitatissimum), Filfil siyah (Piper nigrum) & Honey was given 6gm BD with steam inhalation of Kalonji (Nigella sativa) and Tab Alaspan 1BD with Karvol Plus inhalation was given in Group B.


 


Results Statistical analysis of the data was done using paired T test by comparing the VAS 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 Unani formulation with inhalation of Kalonji has statistically highly significant effect on major and minor symptoms of Chronic Rhinosinusitis.  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.

Keywords: Chronic Rhinosinusitis, Unani Formulation, Katan, Kalonji Inhalation

References

1. Luke Rudmik, Timothy L Smith, Rodney J Schlosser, Peter H Hwang, Jess C Mace, Zachary M Soler et al. Productivity cost in patients with refractory chronic rhinosinusitis.
Laryngoscope, 2014 Sep; 124(9): 2007-12.
2. Aditya M Yeolkar, K S Dasgupta, S Khode, D.Joshi, N.Gosrani et al. A study of SNOT 22 scores in Adults with no Sinonasal disease. Journal of Rhinolaryngo-otologist, 2013; 1(1):6-10.
3. Kennedy D W, F A Kuhn, D L Hamilos, S J Zinreich, D Butler, G Warsi, et al. Treatment of chronic rhinosinusitis with High-dose oral terbinafine: a double-blind, placebo-controlled study. Laryngoscope, 2005 Oct; 115 (10):1793-19
4. Hopkins C, Slack R, Lund V, Copley L, Brown J et al. The national comparative audit of surgery for nasal polyposis and Chronic Rhinosinusitis. Laryngoscope, 2009 Dec; 119 (12): 2459-65.
5. Koosha Ghazi-Moghadam, Hasan Mete Inancli, Naznin Bazazy, Peter K Plinkert, Thomas Efferth, and Sarkan Sertel et al. Review: Phytomedicine in Otorhinolaryn --gology and Pulmonology: Clinical Trials with Herbal Remedies. Pharmaceuticals, 2012 Aug; 20:5 (8): 853-74.
6. Michael S Benninger, MD et al. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology and pathophysio-logy. Supplement to Otolaryngology-Head and neck Surgery; 2003 Sept;129(3) Pages S1–S32
7. Jurjani AH 1878 AD. Zakhira Khwarizm Shahi, Vol.II, Part VI, Urdu Translation by Hkm. Hadi Hasan Khan, Lucknow, Matba Munshi Nawal Kishore; 1903: 205-206
8. Faruk H Al-Jawad, Rafi Am Al-Razzuqi, Hashim M Hashim, Hegazy Ahmad et al. Broncho- relaxant activity of Nigella sativa versus Anthemis nobilis in chronic bronchial asthma; a comparative study of efficacy. IOSRPHR Journal of Pharmacy; 2012 July, 2(4):81-83.
9. Mohammad Kabiruddin: Moalejat; Sharah Asbab, Vol-I, 9th Edition, Hyderabad, Hikmat Book Depo; 1980:15-20
10. Robert M.Naclerio. Xolair in patients with chronic sinusitis. Clinical Trials.gov, US National Institute of Health, University of Chicago.
https://clinicaltrials.gov/ct2/show/NCT00117611
11. Lydia Ferrara, Daniele Naviglio, and Arturo Armone Caruso et al. Cytological Aspects on the Effects of a Nasal Spray consisting of standardized extract of Citrus Lemon and Essential oils in Allergic Rhinopathy. ISRN Pharmaceutics, 2012 Dec: 6 pages.
12. Pratibha N, Saxena, V S Amit, A D'Souza, P Bagchi M and Bagchi D et al. Anti-inflammatory activities of Aller-7, a novel polyherbal formulation for allergic rhinitis. Int J Tissue React 2004; 26(1-2):43-51.
13. Multani HC. Tajul Aqaqeer, Vol.II. Dr.Hari Chand Multani, Panipat,Haryana; NA: 803-4
14. Homayoon Elahi, Mohammad Reza Masroorchehr, Shadman Nemati, Mohammad Kamalinejad, Mehdi Besharat, Homa Hajimehdipoor 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(1)11-20
15. D G Peroni, S Moser, G Gallo, R Pigozzi, L Tenero, L Zanoni et al. Ambroxol inhibits neutrophil respiratory burst activated by alpha chain integrin adhesion. International J.Immuno Pathol Pharmacol.2013; 26(4) 883-87
16. Steve Helms, Alan Miller et al. Natural treatment of chronic rhinosinusitis.Altern Med Rev. 2006 Sept; 11(3):196-207
17. Shigeharu Inouyea Toshio takizawa, Hideyo Yamaguchi et al.Antibacterial activity of essential oils and their major constituents against respiratory tract pathogens by gaseous contact. J. Antimicrobial Chemotherapy; 2001 May; 47(5): 565-73.
18. Hakeem A. Bustanul Mufredat. Delhi, Zafar Book Depo; 1311 H: 221
19. Soheila Nikakhlagh , Fakher Rahim, Faezeh Hossein Nejad Aryani, Amir Syahpoush, Mehri Ghafouryan Brougerdnya, Nader Saki et al. Herbal treatment of allergic rhinitis: the use of Nigella sativa. Am J Otolaryngol .2011; 32 (5):402–407
20. Abdulghani Mohamed Alsamarai, Mohamed Abdulsatar, Amina Hamed Ahmed Alobaidi et al. Evaluation of topical black seed oil in the treatment of allergic rhinitis.Anti-inflamm Anti-allergy Agents Med Chem; 2014 Mar; 13 (1):75-8
21. Mohammad Hossein Boskabady, Nassim Vahedi, Sediqa Amery, Mohammad Reza Khakzad et al. The effect of Nigella sativa alone, and in combination with dexamethasone, on tracheal muscle responsiveness and lung inflammation in sulphur mustard exposed guinea pigs. Journal of Ethnopharmacol, 2011; 137(2):1028-34
22. K.R. Kirtikar and B.D. Basu: Indian Medicinal Plants Vol.-I. Dehradun, International Book Distributors; 1987: 407-10
23. Anonymous, Wealth of India, Vol. VI, New Delhi, C.S.I.R, 1962: 119-40
24. Muhammad Usman Bashir and Hamid Javaid Qureshi et al. Analgesic effect of Kalonji. Journal of the College of Physicians and Surgeons Pakistan, 2010, Vol. 20 (7): 464-467
25. Ram Lubhaya. Goswami Bayanul Adviya Vol-I, Delhi, Goswami Pharmacy; 1984; 101-2
26. Ibne Baiytar 1248. Aljame Almufredat. Aladviya Wal Aghziya,Vol. III, Urdu Translation, New Delhi, CCRUM, 2003: 377-79
27. Sheikh BAIS. Alqanoon Fittib, Vol. II, Lahore, Shiekh Mohd.Tahir & Sons, Pakistan; 2010; 62-63
28. Mohd. Abdul Haleem. Mufredat-e-Azizi. Lucknow, Sahitya Mandir Press; 1948, p 10, 58
29. Najmul M Ghani. Khazaynul Adviya, Vol. I; Sheikh Bashir & Sons, Lahore, Pakistan, 1920: 560-64
30. Amin F Majdalawieh, AF Reem Hmaidan, Ronald I Carr et al. Nigella sativa modulates splenocyte Proliferation, Th1/Th2 cytokine profile, macrophage function and NK anti-tumor activity. Ethnopharmacol 2010 Sep 15; 131(2)268–275
31. Emre Entok, Mehmet Cengiz Ustuner, Cansu Ozbayer, Neslihan Tekin, Fahretti Akyuz Berat Yangi, Hulyam Kurt et al. Anti-inflammatuar and anti-oxidative effects of Nigella sativa L.:18 FDG -PET imaging of inflammation. Mol Biol Rep; 2014 May 41(5):2827-34.
32. N Nakatani, R Inatani, H Ohta, and A Nishioka et al. Chemical constituents of Piper spp.and application to food anti-oxidant preservation: Naturally occurring antioxidative compounds. Environment Health Perspectives, 1986 August,Vol. 67: p135-142
33. R S Vijayakumar , D Surya, N Nalini et al. Antioxidant efficacy of Black Pepper (Piper nigrum L) & Pipperin In rats with high fat diet induced oxidative stress. Redox Rep; 2004; 9 (2):105-10
34. Kasote DN: Flaxseed phenolics as natural antioxidants. International Food Research Journal, 2013; 20(1): 27-34
35. Mohammad Ali. Pharmacognosy” Vol.I, New Delhi; CBS Publishers & Distributers Pvt.Ltd; 2008: 408-11
36. Singh MP and H. Panda. Medicinal herbs with their Formulations Vol-2, Delhi, Daya Publications: 2005; 531-34
37. Ali E.Al-Snafi, Abdul Ghani M Al-Samarai, Ahmad M Al-Sabavi et al. The therapeutic effect of Nigella sativa seed oil in treatment of chronic urticaria. Tikrit Journal of Pharmaceutical Science; 2005, 1(1):1-6
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How to Cite
Zaidi, Z. K., ASIM ALI KHAN, and AZHAR JABEEN. “SINGLE BLIND, RANDOMISED, CONTROL TRIAL OF A UNANI COMPOUND FORMULATION IN ILTEHAB TAJAWEEFE ANAF MUZMIN ”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 1, Jan. 2021, pp. 171-5, https://innovareacademics.in/journals/index.php/ajpcr/article/view/40288.
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