Clinical trial of ozone therapy in mild to moderate Covid-19 subjects.
Phase 1
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026354
- Lead Sponsor
- Bisleri Charitable Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Covid 19 positive RT-PCR (nasopharyngeal swab) result
Adults 30 to 60 of both sex
Mild to Moderately severe disease (NEWS score Less than or equal to 8)
Patients willing to provide informed consent
Exclusion Criteria
Requiring ICU admission and or artificial ventilation at the screening
Any other comorbidity which is with a critical stage at a screening
Any other condition by which subject proves unfit from investigator perspective
Chronic constipation for more than 7 days at the time of screening
Severe stage of disease (NEWS score more than 8)
Patients with G6PD deficiency
Pregnant and breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in X-ray chest: interstitial pattern. <br/ ><br>Changes in hematological parameters like- blood cell counts (Absolute and differential) <br/ ><br>Changes in oxygenation index: SpO2. <br/ ><br>Changes in serum inflammation parameters like- LDH, CRP, ferritin <br/ ><br>Changes in NEWS (National Early Warning Score) <br/ ><br>Number of days for negative RT-PCR test for Covid 19Timepoint: From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier
- Secondary Outcome Measures
Name Time Method Change in clinical symptom presentation on 5 point ordinal scale. <br/ ><br>Requirement of admission to intensive care unit and hospital admission. <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating. <br/ ><br>Tolerability of intervention by study subjects. <br/ ><br>Changes in biochemical parameters such as liver function test, renal function test, serum electrolyte etc. <br/ ><br>Global assessment score for overall improvement by Investigator and subject.Timepoint: From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier