The Clinical Efficacy of Tiban Syrup as Adjuvant Treatment in Patients with COVID-19: A Randomized, Double-Blind Clinical Trial The clinical efficacy of Tiban syrup on COVID-19
Iranian Journal of Pharmaceutical Sciences,
Vol. 17 No. 3 (2021),
1 July 2021
,
Page 49-62
https://doi.org/10.22037/ijps.v17.40273
Abstract
Since the outbreak of the COVID-19 pandemic, we have witnessed extensive morbidity and mortality worldwide. However, an appropriate pharmaceutical treatment has not yet been introduced for this disease, and finding a safe and effective treatment is still ongoing. This study aimed to evaluate the safety and efficacy of Tiban (Mocozift) syrup (an herbal product of Trachyspermum ammi (L.) Sprague (Ajwain) and Ziziphus jujuba Mill. (jujube)) in adult patients with COVID-19. Patients with laboratory-confirmed SARS-CoV-2 infection were enrolled and randomly assigned to receive either placebo or Tiban syrup 5 cc, three times a day for 14 days, in addition to standard medications of COVID-19. Improvement in clinical outcomes, including cough, fatigue, dyspnea, appetite, and the occurrence of in-hospital mortality, were recorded.A total of 50 patients completed the study. The mean age of the patients was 56.5 years. There were 21 (42%) male and 29 (58%) female patients. There was a significant reduction in dyspnea after taking medication (p=0.001). Patients’ appetite significantly increased in the Tiban group (p=0.001). Also, a significant decrease was observed in the severity of fatigue score in the Tiban group (p=0.001). Compared to the placebo group, an increase in appetite and a decrease in fatigue occurred earlier in the Tiban group.The findings of this study suggest that the combination therapy with Tiban syrup and conventional medicine can reduce severity of dyspnea and fatigue, while it can increase appetite in patients with mild to moderate COVID-19.
Keywords:
- Appetite
- COVID-19
- Dyspnea
- Fatigue
- Mocozift
- Tiban
- Trachyspermum ammi
- Ziziphus jujube
How to Cite
Kamalinejad, M., Sarmadian, H., Shokouhi, F., Dadmehr, M., Bahrami, M., Dehnad, A., … Latifi, S. A. (2021). The Clinical Efficacy of Tiban Syrup as Adjuvant Treatment in Patients with COVID-19: A Randomized, Double-Blind Clinical Trial: The clinical efficacy of Tiban syrup on COVID-19. Iranian Journal of Pharmaceutical Sciences, 17(3), 49–62. https://doi.org/10.22037/ijps.v17.40273
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[39] Boskabady MH, Alizadeh M, Jahanbin B. Bronchodilatory effect of Carum copticum in airways of asthmatic patients. Therapie (2007) 62 (1): 23-29.
[40] Wadikar DD, Premavalli KS. Ajowan (Trachyspermum ammi) munch: A shelf stable ready-to-eat appetizer, its development and storage. Int. Food Res. J. (2012) 19 (1): 321-325.
[41] Kumar P, Wadikar D, Patki P. A ready-to-eat antioxidant rich appetizer based on Coleus aromaticus: its development and shelf life evaluation. J. Food Process. (2014) 2014.
[42] Thangam C, Dhananjayan R. Antiinflammatory potential of the seeds of Carum copticum Linn. Indian J. Pharmacol. (2003) 35(6): 388-391.
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[2] Guan WJ, et al. Clinical characteristics of coronavirus disease 2019 in China. N. Engl. J. Med. (2020) 382 (18): 1708-1720.
[3] Wang D, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumonia in Wuhan, China. Jama. (2020) 323 (11): 1061-1069.
[4] Dehghanbanadaki H, Seif F, Vahidi Y, Razi F, Hashemi E, Khoshmirsafa M, Aazami H. Bibliometric analysis of global scientific research on Coronavirus (COVID-19). Med. J. Islam. Repub. Iran. (2020) 34:51.
[5] Huang C, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet (2020) 395(10223): 497-506.
[6] Shi S, et al. Association of cardiac injury with mortality in hospitalized patients with COVID-19 in Wuhan, China. JAMA Cardiol. (2020) 5(7): 802-810.
[7] Nezhad MS, et al. An overview of the prominence of current diagnostic methods for diagnosis of COVID-19. AIMS Allergy Immunol. (2020) 4(3): 60-74.
[8] Tu YF, et al. A review of SARS-CoV-2 and the ongoing clinical trials. Int. J. Mol. Sci. (2020) 21(7): 2657.
[9] Cao X, COVID-19: immunopathology and its implications for therapy. Nat. Rev. Immunol. (2020) 20 (5): 269-270.
[10] McGonagle D, Sharif K, O'Regan A, Bridgewood C. The role of cytokines including interleukin-6 in COVID-19 induced pneumonia and macrophage activation syndrome-like disease. Autoimmun. Rev. (2020) 19 (6): 102537.
[11] Liu B, Li M, Zhou Z, Guan X, Xiang Y. Can we use interleukin-6 (IL-6) blockade for coronavirus disease 2019 (COVID-19)-induced cytokine release syndrome (CRS). J. Autoimmun.. (2020) 111: 102452.
[12] Clerkin, K., et al. COVID-19 and cardiovascular disease. Circulation (2020) 141 (20): 1648-55.
[13] Kapoor R, Sharma B, Kanwar SS. Antiviral phytochemicals: an overview. Biochem. Physiol. (2017) 6(2):7.
[14] Naithani R, Huma LC, Holland LE, Shukla D, McCormick DL, Mehta RG, Moriarty RM. Antiviral activity of phytochemicals: a comprehensive review. Mini Rev. Med. Chem. (2008) 8(11): 1106-1133.
[15] Ben-Shabat S, Yarmolinsky L, Porat D, Dahan A. Antiviral effect of phytochemicals from medicinal plants: applications and drug delivery strategies. Drug Deliv. Transl. Res. (2020) 10(2):354-67.
[16] Amirghofran Z, Herbal medicines for immunosuppression. Iran. J. Allergy Asthma Immunol. (2012): 111-119.
[17] Bairwa R, Sodha RS, Rajawat BS. Trachyspermum ammi. Pharmacog. Rev. (2012) 6(11):56.
[18] Boskabady MH, Alitaneh S, Alavinezhad A. Carum copticum L.: a herbal medicine with various pharmacological effects. Biome. Res. Int. (2014) 2014.
[19] Zarshenas MM, Moein M, Samani SM, Petramfar P. An overview on ajwain (Trachyspermum ammi) pharmacological effects; modern and traditional. J. Nat. Remedies. (2013) 14(1):98-105.
[20] Korani M, Jamshidi M. The effect of aqueous extract of trachyspermum ammi seeds and ibuprofen on inflammatory gene expression in the cartilage tissue of rats with collagen-induced arthritis. J. Inflamm. Res. (2020) 13:133.
[21] Namjooyan F, Ghanavati R, Majdinasab N. The efficacy of traditional formulation on quality of life and fatigue in multiple sclerosis patients: a randomized double-blind placebo-control clinical trial. J. Contemp. Med. Sci. (2019) 5 (2): 96-100.
[22] Hong EH, Song JH, Kang KB, Sung SH, Ko HJ, Yang H. Anti-influenza activity of betulinic acid from Zizyphus jujuba on influenza A/PR/8 virus. Biomol. Ther. (2015) 23 (4): 345–349.
[23] Ninave PB, Patil SD. Antiasthmatic potential of Zizyphus jujuba Mill and Jujuboside B.–Possible role in the treatment of asthma. Respir. Physiol. Neurobiol. (2019) 260 :28-36.
[24] Rodriguez Villanueva J, Rodriguez Villanueva L. Experimental and clinical pharmacology of Ziziphus jujuba Mills. Phytother. Res. (2017) 31 (3): 347-365.
[25] Mohebbati R, Bavarsad K, Rahimi M, Rakhshandeh H, Rad AK, Shafei MN. Protective effects of long-term administration of Ziziphus jujuba fruit extract on cardiovascular responses in L-NAME hypertensive rats. Avicenna J. Phytomedicine (2018) 8 (2): 143-151.
[26] Valko PO, Bassetti CL, Bloch KE, Held U, Baumann CR. Validation of the fatigue severity scale in a Swiss cohort. Sleep (2008) 31 (11): 1601-1607.
[27] Wilson MM, et al. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am. J. Clin. Nutr. (2005) 82 (5): 1074-1081.
[28] Papaioannou AI, Loukides S, Gourgoulianis KI, Kostikas K. Global assessment of the COPD patient: time to look beyond FEV1? Respir. Med. (2009) 103 (5): 650-560.
[29] Spinou A, Birring SS. An update on measurement and monitoring of cough: what are the important study endpoints? J. Thorac. Dis. (2014) 6 (7): S728-734.
[30] Bahrami M, Kamalinejad M, Latifi SA, Seif F, Dadmehr M. Cytokine storm in COVID‐19 and parthenolide: preclinical evidence. Phytother. Res. (2020) 34 (10): 2429-30.
[31] Roshanravan N, Seif F, Ostadrahimi A, Pouraghaei M, Ghaffari S. Targeting Cytokine Storm to Manage Patients with COVID-19: A Mini-Review. Arch. Med. Res. (2020) 51 (7): 608-612.
[32] Seif F, Aazami H, Khoshmirsafa M, Kamali M, Mohsenzadegan M, Pornour M, Mansouri D. JAK inhibition as a new treatment strategy for patients with COVID-19. Int. Arch. Allergy Immunol. (2020) 181 (6): 467-475.
[33] Rasouli, S., Study of Interleukin-6 and STAT-3 Genes Expression Levels in Skin of Mouse Model of Experimental Contact Dermatitis Treated with Aqueous Extract of Trachspermum copticum L. link Seeds.
[34] Rasouli S, Karimi F, Anissian A, Bandehpour M, Kamalinejad M. Interleukin-1 and Keratinocyte Growth Factor/Fibroblast Growth Factor-7 Gene Expression in Skin Experimental Irritant Contact Dermatitis Mouse Model Treated with Aqueous Extract of Trachyspermum copticum (L.) Link Seeds. NBM. (2018) 6 (3): 138-146.
[35] Kazemi Oskuee R, Behravan J, Ramezani M. Chemical composition, antimicrobial activity and antiviral activity of essential oil of Carum copticum from Iran. Avicenna J. Phytomedicine (2011) 1(2): 83-90.
[36] Boskabady MH, Jandaghi P, Kiani S, Hasanzadeh L. Antitussive effect of Carum copticum in guinea pigs. J. Ethnopharmacol. (2005) 97 (1): 79-82.
[37] Boskabady MH, Shaikhi J. Inhibitory effect of Carum copticum on histamine (H1) receptors of isolated guinea-pig tracheal chains. J. Ethnopharmacol. (2000) 69 (3): 217-227.
[38] Boskabady MH, Ramazani M, Tabei T. Relaxant effects of different fractions of essential oil from Carum copticum on guinea pig tracheal chains. Phytother. Res. (2003) 17 (10): 1145-1149.
[39] Boskabady MH, Alizadeh M, Jahanbin B. Bronchodilatory effect of Carum copticum in airways of asthmatic patients. Therapie (2007) 62 (1): 23-29.
[40] Wadikar DD, Premavalli KS. Ajowan (Trachyspermum ammi) munch: A shelf stable ready-to-eat appetizer, its development and storage. Int. Food Res. J. (2012) 19 (1): 321-325.
[41] Kumar P, Wadikar D, Patki P. A ready-to-eat antioxidant rich appetizer based on Coleus aromaticus: its development and shelf life evaluation. J. Food Process. (2014) 2014.
[42] Thangam C, Dhananjayan R. Antiinflammatory potential of the seeds of Carum copticum Linn. Indian J. Pharmacol. (2003) 35(6): 388-391.
[43] Umar S, et al. Anti-inflammatory and antioxidant activity of Trachyspermum ammi seeds in collagen induced arthritis in rats. Int. J. Drug Dev. Res. (2012) 4 (1): 210-219.
[44] Bajpai VK, Agrawal P. Studies on phytochemicals, antioxidant, free radical scavenging and lipid peroxidation inhibitory effects of Trachyspermum ammi seeds. Indian J. Pharm. Educ. Res. (2015) 49: 58-65.
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