Downloading: Phase I/II Randomized Controlled Clinical Trial to Assess Safety and Efficacy of Ozone Therapy via Rectal Insufflation and Minor Auto Haemotherapy as an Adjuvant in Mild to Moderate COVID-19 Subjects
International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
www.ijsr.net | Open Access | Fully Refereed | Peer Reviewed International Journal

ISSN: 2319-7064


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Phase I/II Randomized Controlled Clinical Trial to Assess Safety and Efficacy of Ozone Therapy via Rectal Insufflation and Minor Auto Haemotherapy as an Adjuvant in Mild to Moderate COVID-19 Subjects

Mili Shah, Jignasha Captain, Vidyadhar Vaidya, Arvind Kulkarni, Kedar Valsangkar, Gayatri Ganu

Abstract: Aims: The present study is proposed to evaluate the safety and efficacy of ozone therapy as an adjuvant along with standard treatment in mild to moderate patients of COVID-19. Settings and Design: This was a randomized, controlled clinical trial with 60 subjects in ozone and standard treatment group (1:1). Methods and Material: Adult subjects of age 30 to 60 of both sex with COVID 19 positive RT-PCR result with mild to moderately severe disease were randomly allocated in either standard treatment or ozone treated group. The RT-PCR test was repeated on day 5 and 10 along with the biochemical tests. Statistical analysis used: Negative RT-PCR test was used for calculation of sample size by software SPSS Version 10.0, the sample size derived for 80% confidence interval as 60 completer subjects i.e. 30 in each group. Results and conclusion: 77% subjects from ozone treated group and 53% from standard treatment group were RT-PCR negative. At day 10, 100% from ozone treatment and 70% from standard treatment were RT-PCR negative. There was significant reduction in clinical symptoms like cough and breathlessness in ozone treated subjects. The inflammatory markers like CRP, LDH and ferritin were reduced more in magnitude than standard treatment group indicating anti-inflammatory potential of ozone therapy. All the biochemical markers like liver, lipid and kidney function test for patients with both groups were within normal range throughout the study. Overall Ozone Therapy was found to be safe and effective choice in management of patients presenting mild to moderate COVID 19.

Keywords: Ozone, COVID-19, RT-PCR, CRP, LDH, ferritin


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