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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 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 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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. |