Essential oil nebulization in mild COVID-19(EONCO): Early phase exploratory clinical trial

Medications studied for therapeutic benefits in coronavirus disease 2019 (COVID-19) have produced inconclusive efficacy results except for steroids. A prospective randomized open-label, parallel-arm Phase I/II clinical trial was planned to compare essential oil (EO) blend versus placebo nebulization...

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Veröffentlicht in:Journal of ayurveda and integrative medicine 2022-07, Vol.13 (3), p.100626-100626, Article 100626
Hauptverfasser: Rathod, Ramya, Mohindra, Ritin, Vijayakumar, Akshay, Soni, Roop Kishor, Kaur, Ramandeep, Kumar, Ankit, Hegde, Naveen, Anand, Aishwarya, Sharma, Swati, Suri, Vikas, Goyal, Kapil, Ghosh, Arnab, Bhalla, Ashish, Gamad, Nanda, Singh, Amrit Pal, Patil, Amol N.
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Sprache:eng
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Zusammenfassung:Medications studied for therapeutic benefits in coronavirus disease 2019 (COVID-19) have produced inconclusive efficacy results except for steroids. A prospective randomized open-label, parallel-arm Phase I/II clinical trial was planned to compare essential oil (EO) blend versus placebo nebulization in mild COVID-19. A Phase I safety evaluation was carried out in a single ascending and multiple ascending dose study designs. We assessed Phase II therapeutic efficacy on COVID-19 and general respiratory symptoms on days 0, 3, 5, 7, 10, and 14 on the predesigned case record form. Viremia was evaluated on day 0, day 5, and day 10. Dose-limiting toxicities were not reached with the doses, frequencies, and duration studied, thus confirming the formulation's preliminary safety. General respiratory symptoms (p 
ISSN:0975-9476
0976-2809
DOI:10.1016/j.jaim.2022.100626