A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients

Summary

Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable. For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients. For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis. For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses. Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.

Timeline

Start

2021-12-01

Primary completion

2022-06-30

Completion

2022-07-31

Publications

• Background Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.
• Background Shafiq HB, Amin U, Nawaz S. Comparative analysis of various antimicrobial agents present in locally available mouthwashes against oral pathogens. Pak J Pharm Sci. 2018 Sep;31(5):1881-1887.
• Background Tanzer JM, Slee AM, Kamay BA. Structural requirements of guanide, biguanide, and bisbiguanide agents for antiplaque activity. Antimicrob Agents Chemother. 1977 Dec;12(6):721-9. doi: 10.1128/AAC.12.6.721.
• Background Lai P, Coulson C, Pothier DD, Rutka J. Chlorhexidine ototoxicity in ear surgery, part 1: review of the literature. J Otolaryngol Head Neck Surg. 2011 Dec;40(6):437-40.
• Background Hirata K, Kurokawa A. Chlorhexidine gluconate ingestion resulting in fatal respiratory distress syndrome. Vet Hum Toxicol. 2002 Apr;44(2):89-91.
• Background Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.
• Background Tiwari V, Darmani NA, Yue BY, Shukla D. In vitro antiviral activity of neem (Azardirachta indica L.) bark extract against herpes simplex virus type-1 infection. Phytother Res. 2010 Aug;24(8):1132-40. doi: 10.1002/ptr.3085.
• Background Ahmad A, Javed MR, Rao AQ, Husnain T. Designing and screening of universal drug from neem (Azadirachta indica) and standard drug chemicals against influenza virus nucleoprotein. BMC Complement Altern Med. 2016 Dec 16;16(1):519. doi: 10.1186/s12906-016-1469-2.
• Background Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.
• Background Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
• Background Chen L, Liu HG, Liu W, Liu J, Liu K, Shang J, Deng Y, Wei S. [Analysis of clinical features of 29 patients with 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 6;43(0):E005. doi: 10.3760/cma.j.issn.1001-0939.2020.0005. Online ahead of print. Chinese.
• Background Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
• Background Sharma R, Hebbal M, Ankola AV, Murugaboopathy V, Shetty SJ. Effect of two herbal mouthwashes on gingival health of school children. J Tradit Complement Med. 2014 Oct;4(4):272-8. doi: 10.4103/2225-4110.131373.
• Background Chatterjee A, Saluja M, Singh N, Kandwal A. To evaluate the antigingivitis and antipalque effect of an Azadirachta indica (neem) mouthrinse on plaque induced gingivitis: A double-blind, randomized, controlled trial. J Indian Soc Periodontol. 2011 Oct;15(4):398-401. doi: 10.4103/0972-124X.92578.
• Background Chava VR, Manjunath SM, Rajanikanth AV, Sridevi N. The efficacy of neem extract on four microorganisms responsible for causing dental caries viz Streptococcus mutans, Streptococcus salivarius, Streptococcus mitis and Streptococcus sanguis: an in vitro study. J Contemp Dent Pract. 2012 Nov 1;13(6):769-72. doi: 10.5005/jp-journals-10024-1227.
• Background Alzohairy MA. Therapeutics Role of Azadirachta indica (Neem) and Their Active Constituents in Diseases Prevention and Treatment. Evid Based Complement Alternat Med. 2016;2016:7382506. doi: 10.1155/2016/7382506. Epub 2016 Mar 1.
• Background Badam L, Joshi SP, Bedekar SS. 'In vitro' antiviral activity of neem (Azadirachta indica. A. Juss) leaf extract against group B coxsackieviruses. J Commun Dis. 1999 Jun;31(2):79-90.
• Background Arora R, Chawla R, Marwah R, Arora P, Sharma RK, Kaushik V, Goel R, Kaur A, Silambarasan M, Tripathi RP, Bhardwaj JR. Potential of Complementary and Alternative Medicine in Preventive Management of Novel H1N1 Flu (Swine Flu) Pandemic: Thwarting Potential Disasters in the Bud. Evid Based Complement Alternat Med. 2011;2011:586506. doi: 10.1155/2011/586506. Epub 2010 Oct 13.
• Background Siddiqui BS, Ali SK, Ali ST, Naqvi SN, Tariq RM. Variation of major limonoids in Azadirachta indica fruits at different ripening stages and toxicity against Aedes aegypti. Nat Prod Commun. 2009 Apr;4(4):473-6.
• Burton MJ, Clarkson JE, Goulao B, Glenny AM, McBain AJ, Schilder AG, Webster KE, Worthington HV. Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them. Cochrane Database Syst Rev. 2020 Sep 16;9(9):CD013627. doi: 10.1002/14651858.CD013627.pub2.
• Khan FR, Kazmi SMR, Iqbal NT, Iqbal J, Ali ST, Abbas SA. A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 14;21(1):785. doi: 10.1186/s13063-020-04634-2.

Drugs

Indications