NCT04900129

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

Completed Phase 1 Last updated 25 May 2021

What this trial tests

Phase 1 trial testing Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% in Covid19 in 43 participants. Completed in 30 December 2020.

Timeline

1 December 2020

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Sher-E-Bangla Medical College
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	43
Start date	1 December 2020
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across Bangladesh

Drugs / interventions tested

• Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm%

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Sher-E-Bangla Medical College

Who can join

20 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. N-Acetylcysteine and Its Immunomodulatory Properties in Humans and Domesticated Animals.
   Tieu S, Charchoglyan A, Paulsen L, Wagter-Lesperance LC, et al · · 2023 · cited 28× · PMID 37891946 · DOI 10.3390/antiox12101867
2. Molecular Mechanisms Related to Responses to Oxidative Stress and Antioxidative Therapies in COVID-19: A Systematic Review.
   Tsermpini EE, Glamočlija U, Ulucan-Karnak F, Redenšek Trampuž S, et al · · 2022 · cited 27× · PMID 36009328 · DOI 10.3390/antiox11081609