Inhalation of Vapor With Medication (Diclofenac Sodium, Menthol, Methyl Salicylate and N-Acetyl Cysteine) Reduces Oxygen Need and Hospital Stay in COVID-19 Patients - A Case Control Study
NCT ID: NCT04900129
Last Updated: 2021-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2020-12-01
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Duration: One month Study Place: Corona unit, Sher-E-Bangla Medical College Hospital, Barishal. Sample Size: Total 43 patients (N). Among them study group (SG) had 27 respondents and control group (CG) had 16 respondents Materials: Suitable vapor producing electric teapot, medicine, pulse oximeter and a structured questionnaire
TREATMENT
DOUBLE
Study Groups
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Study Group
This group inhaled vapor containing Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% twice daily in addition to conventional treatment. That is, 100 gram of emulsion contain diclofenac sodium 1 gram, N-acetyl cysteine 1.2 gm, menthol 20 mg, and methyl salicylic acid 50 mg. These drugs have no systemic and local side effects in these small doses, though it may cause slight eye irritation.
Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm%
inhaled vapor containing Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% twice daily in addition to conventional treatment. That is, 100 gram of emulsion contain diclofenac sodium 1 gram, N-acetyl cysteine 1.2 gm, menthol 20 mg, and methyl salicylic acid 50 mg.
Control Group
This group inhaled plain aquatic vapor in addition to conventional treatment.
No interventions assigned to this group
Interventions
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Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm%
inhaled vapor containing Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% twice daily in addition to conventional treatment. That is, 100 gram of emulsion contain diclofenac sodium 1 gram, N-acetyl cysteine 1.2 gm, menthol 20 mg, and methyl salicylic acid 50 mg.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Sher-E-Bangla Medical College
OTHER
Responsible Party
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Harendra Nath Sarker
Professor
Locations
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HN Sarker
Barishal, , Bangladesh
Countries
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References
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Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11.
Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
Woyke S, Rauch S, Strohle M, Gatterer H. Modulation of Hb-O2 affinity to improve hypoxemia in COVID-19 patients. Clin Nutr. 2021 Jan;40(1):38-39. doi: 10.1016/j.clnu.2020.04.036. Epub 2020 Apr 28.
Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.
Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
Griffiths MJD, McAuley DF, Perkins GD, Barrett N, Blackwood B, Boyle A, Chee N, Connolly B, Dark P, Finney S, Salam A, Silversides J, Tarmey N, Wise MP, Baudouin SV. Guidelines on the management of acute respiratory distress syndrome. BMJ Open Respir Res. 2019 May 24;6(1):e000420. doi: 10.1136/bmjresp-2019-000420. eCollection 2019.
Mairbaurl H, Weber RE. Oxygen transport by hemoglobin. Compr Physiol. 2012 Apr;2(2):1463-89. doi: 10.1002/cphy.c080113.
Dempsey JA. With haemoglobin as with politics - should we shift right or left? J Physiol. 2020 Apr;598(8):1419-1420. doi: 10.1113/JP279555. Epub 2020 Mar 13. No abstract available.
Mairbaurl H. Red blood cell function in hypoxia at altitude and exercise. Int J Sports Med. 1994 Feb;15(2):51-63. doi: 10.1055/s-2007-1021020.
de Wit E, van Doremalen N, Falzarano D, Munster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol. 2016 Aug;14(8):523-34. doi: 10.1038/nrmicro.2016.81. Epub 2016 Jun 27.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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SBMC|Barisal|2020|1896
Identifier Type: -
Identifier Source: org_study_id
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