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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

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ClinicalTrials.gov Identifier: NCT04900129
Recruitment Status : Completed
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Harendra Nath Sarker, Sher-E-Bangla Medical College

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Combination Product: Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Methods: Case control study Population: Adult patients with RT-PCR +ve mild to moderate COVID 19. Severe and critical disease patients had been excluded from the study.

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
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Combination Product: 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.
No Intervention: Control Group
This group inhaled plain aquatic vapor in addition to conventional treatment.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04900129


Locations
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Bangladesh
HN Sarker
Barisal, Bangladesh, 1207
Sponsors and Collaborators
Sher-E-Bangla Medical College
  Study Documents (Full-Text)

Documents provided by Harendra Nath Sarker, Sher-E-Bangla Medical College:
Statistical Analysis Plan  [PDF] May 23, 2021

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Harendra Nath Sarker, Professor, Sher-E-Bangla Medical College
ClinicalTrials.gov Identifier: NCT04900129    
Other Study ID Numbers: SBMC|Barisal|2020|1896
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harendra Nath Sarker, Sher-E-Bangla Medical College:
Vapor
RT-PCR
Oxygen Saturation
Additional relevant MeSH terms:
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COVID-19
Acetylcysteine
N-monoacetylcystine
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Diclofenac
 Salicylates
Methyl salicylate
Menthol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics