Covid19 Clinical Trial
Official title:
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
| Verified date | May 2021 |
| Source | Sher-E-Bangla Medical College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background: In the midst of the devastating COVID pandemic where there is no specific and effective treatment, traditional therapy may help to ease the patient's suffering. Inhalation of vapor (VP) is an essential home remedy for stuffy, running nose in common cold, influenza and sinusitis. Steam inhalation is helpful in destroying the capsid of the SARS-CoV-2 envelope and preventing infection. Vapor with diclofenac sodium, menthol, methyl salicylate and N-acetyl cysteine may augment this effect. Objective: To evaluate the effect of inhalation of vapor with medication and to compare with inhalation of vapor without medication. Methods and Materials: A case control study taken place in Corona unit, Sher-E-Bangla Medical College Hospital, Barishal. 43 patients with mild to moderate COVID-19 were participated in this study. All are RT-PCR positive cases. Among them 16 patients were in control group and 27 in study group. In study group they were given vapor with Diclofenac Sodium, Menthol, Methyl Salicylate and N-Acetyl Cysteine and control group they were given normal steam/aquatic vapor two times in a day.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | December 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | Inclusion Criteria: - Patient must be COVID 19 positive and having a lack of oxygen saturation. Exclusion Criteria: - All the patients who do not covid infected. |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | HN Sarker | Barisal |
| Lead Sponsor | Collaborator |
|---|---|
| Sher-E-Bangla Medical College |
Bangladesh,
Alhazzani W, Møller 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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Mairbäurl H, Weber RE. Oxygen transport by hemoglobin. Compr Physiol. 2012 Apr;2(2):1463-89. doi: 10.1002/cphy.c080113. Review. — View Citation
Mairbäurl H. Red blood cell function in hypoxia at altitude and exercise. Int J Sports Med. 1994 Feb;15(2):51-63. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Woyke S, Rauch S, Ströhle M, Gatterer H. Modulation of Hb-O(2) 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | This study determined that after regular inhalation of vapor with above medication, oxygen saturation level increased in the study group 384.61% in the morning and 515.79% at night comparing the control group. Furthermore, patients of study group need to stay nearly 1 day less in hospital in comparison to control group. | 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
| Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
| Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
| Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
| Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
| Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
| Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
| Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
| Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
| Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
| Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
| Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
| Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
| Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |