Clinical trial of ozone therapy in mild to moderate Covid-19 subjects.

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. - Nil

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026354

Enrollment

Registered

2020-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Ozone therapy together with standard of care: Ozone therapy via rectal insufflation and minor auto haemotherapy together with standard of care daily for 10 days or negative RT-PCR for C

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Changes in X-ray chest: interstitial pattern. Changes in hematological parameters like- blood cell counts (Absolute and differential) Changes in oxygenation index: SpO2. Changes in serum inflammation parameters like- LDH, CRP, ferritin Changes in NEWS (National Early Warning Score) 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	—

Measure

Time frame

Changes in X-ray chest: interstitial pattern. Changes in hematological parameters like- blood cell counts (Absolute and differential) Changes in oxygenation index: SpO2. Changes in serum inflammation parameters like- LDH, CRP, ferritin Changes in NEWS (National Early Warning Score) 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

Measure	Time frame
Change in clinical symptom presentation on 5 point ordinal scale. Requirement of admission to intensive care unit and hospital admission. Clinical status expressed in percentage of subjects reporting each severity rating. Tolerability of intervention by study subjects. Changes in biochemical parameters such as liver function test, renal function test, serum electrolyte etc. 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	—

Measure

Time frame

Change in clinical symptom presentation on 5 point ordinal scale. Requirement of admission to intensive care unit and hospital admission. Clinical status expressed in percentage of subjects reporting each severity rating. Tolerability of intervention by study subjects. Changes in biochemical parameters such as liver function test, renal function test, serum electrolyte etc. 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

—

Countries

India

Contacts

Public ContactDr Jignasha Captain

Ozone Forum of India

drmilishah@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026