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CTRI Number  CTRI/2020/07/026354 [Registered on: 04/07/2020] Trial Registered Prospectively
Last Modified On: 12/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ozone therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial of ozone therapy in mild to moderate Covid-19 subjects. 
Scientific Title of Study   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. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/20-21/005 Version 1.0 dated, 15th June 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mili Shah 
Designation  President, Ozone forum of India 
Affiliation  Ozone Forum of India 
Address  3rd Flr, Bisleri Tower, Western Express Highway,Andheri (E) Mumbai 400 099

Mumbai
MAHARASHTRA
400 099
India 
Phone    
Fax    
Email  drmilishah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mili Shah 
Designation  President, Ozone forum of India 
Affiliation  Ozone Forum of India 
Address  3rd Flr, Bisleri Tower, Western Express Highway,Andheri (E) Mumbai 400 099

Mumbai
MAHARASHTRA
400 099
India 
Phone    
Fax    
Email  drmilishah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jignasha Captain  
Designation  Director, Ozone forum of India 
Affiliation  Ozone Forum of India 
Address  3rd Flr, Bisleri Tower, Western Express Highway,Andheri (E) Mumbai 400 099

Mumbai
MAHARASHTRA
400 099
India 
Phone    
Fax    
Email  drjigna911@hotmail.com  
 
Source of Monetary or Material Support  
Bisleri Charitable Trust 3rd Flr, Bisleri Tower, Western Express Highway,Andheri (E) Mumbai 400 099 
 
Primary Sponsor  
Name  Bisleri Charitable Trust 
Address  3rd Flr, Bisleri Tower, Western Express Highway, Andheri (E) Mumbai 400 099 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mili Shah  Lokmanya Hospital  3 floor, Lokmanya Medical Research Center Survey No 314/B, Telco Road, Near Chinchwad Rly station, Chincwad Pune - 411033
Pune
MAHARASHTRA 
9819376454

drmilishah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Lokmanya Medical Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 Covid 19 whichever is earlier. 
Comparator Agent  Standard of care as per ICMR protocol for Covid 19  Standard of care daily for 10 days or negative RT-PCR for Covid 19 whichever is earlier. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 19 
From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   13/07/2020 
Date of Study Completion (India) 04/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Brief Summary
Modification(s)  

The treatment of Ozone along with the standard of care in mild to moderate patients of COVID 19 provided a clinical advantage over only standard of care treatment. There was improved SPO2, clinical symptoms status. There was faster viral eradication from host cells. 77% of subjects from the ozone-treated group were RT-PCR negative on day 5 and 100% subjects were RT-PCR negative on day 10.  There was a significant reduction in clinical symptoms like cough and breathlessness in ozone-treated subjects. X-ray investigations revealed a fact that there is a resolution of pulmonary infiltration in 5 to 10 days of treatment of ozone therapy along with the standard of care in consensus with their RT-PCR negativity. The inflammatory markers like CRP, LDH, and ferritin were reduced more in magnitude than the standard group indicating that the patient is protected through anti-inflammatory activity to halt the progression of the disease. Ozone treatment has reduced the hospital stay of patients. The quality of life of patients was very much improved in ozone-treated patients than that of the standard treatment alone. 10% of subjects from the standard of care were in requirement of ICU admission and artificial ventilation of which two patients progressed to death. In ozone-treated group there were 100% subjects on air and no requirement of oxygen supplementation and ICU. No fatality in the ozone-treated group. There was 100% compliance of patients to ozone therapy with a zero dropout rate. All the biochemical markers like liver, lipid, and kidney function tests for patients with both groups were within normal range throughout the study. It indicates the safety of the ozone therapy in COVID 19 patients. Overall Ozone Therapy was found to be a safe and effective choice in the management of patients presenting mild to moderate clinical presentation of COVID 19 in 10 days’ treatment.


 
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