Evaluation of the effect of oxygen-rich water as an adjunct to supportive therapy in improving the clinical condition of patients with Covid 19
Design
From the case of Patients with Covid 19 admitted to Razi Hospital who apply to participate in this project, 40 people are selected randomly due to a possible drop of ten percent, ie 44 people. After matching the variables of age, sex, occupation (demographic variables) and underlying diseases, they are randomly divided into two groups of 22 people. The clinical trial has a control group, parallel, double-blind randomized.
Settings and conduct
Razi hospital, Ahvaz. Patients and clinicals who were also responsible for collecting data were unware of the type of water used.
Participants/Inclusion and exclusion criteria
Inclution Criteria:
Patients with Covid 19 hospitalized
Patients with less than normal blood oxygenation
Exclution Criteria:
patients hospitalized in I.C.U. ward
Patients who are unable receive water for any reason
Intervention groups
In the treatment group, in addition to the usual drug treatment, the patient is given 300 ml of oxygen-rich water as standard every four hours ."Control group:" In the control group, in addition to the usual drug treatment, patients are given 300 ml of refined urban drinking water every four hours daily in bottles similar to the intervention group. Blood oxygenation of all patients is measured by pulse oximetry before and 5 minutes after drinking water. Also, respiration rate per minute of all patients is measured and recorded before and 5 minutes after water consumption. This operation lasts for a week.
Main outcome variables
The amount of oxygen saturation in the blood ; The rate of respiration per minute
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201125049486N1
Registration date:2020-12-24, 1399/10/04
Registration timing:registered_while_recruiting
Last update:2020-12-24, 1399/10/04
Update count:2
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
masoud veissi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2552
Email address
veissi-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oxygen-rich water as an adjunct to supportive therapy in improving the clinical condition of patients with COVID-19
Public title
The use of oxygen-enrich water in therapy of patients with Covid 19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Corona's patients hospitalized
Patients with blood oxygenation less than normal
Exclusion criteria:
Patients hospitalized in I.C.U ward
Patients who are unable receive water for any reason
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block designs:
Patients are divided into two groups: control (a) and intervention (b). Patients are randomly divided into 6 blocks of four (AB-AB, BA-BA, AA- AB, BB--AA, AB -BA and BA-AB) .
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, oxygen-rich water and refined drinking water are provided to in similar containers (with a special sign to identify the type of water by the researcher). The researcher colleague and clinicians in the ward are told based on Based on randomized grouping, which patients should be given which type of water . Patients also do not know the type of water received.Patients and clinicians who were also responsible for data collection were unaware of the type of water used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, School of allied medicine Sciences, Department of Nutrition
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.AJUMS.REC.1399.658
Health conditions studied
1
Description of health condition studied
Covid 19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified.
Primary outcomes
1
Description
Blood oxygen saturation
Timepoint
Every four hours, the Blood oxygen saturation of all patients before and 5 minutes after water consumption is measured and recorded .
Method of measurement
With pulse oximetry
Secondary outcomes
1
Description
Respiration rate per minute
Timepoint
Every four hours, the respiration rate per minute of all patients before and 5 minutes after water consumption is measured and recorded.
Method of measurement
The rate of respiration (one inhale and one exhale) is counted in 30 seconds and is recorded as twice the number of respiration per minute.
Intervention groups
1
Description
Treatment group: In the treatment group, in addition to the usual drug treatment, the patient is given 300 ml of oxygen-rich water as standard every four hours (which is prepared daily in a thick PET bottle). Blood oxygenation of all patients is measured by pulse oximetry before and 5 minutes after drinking water. Also, respiration rate per minute of all patients is measured and recorded before and 5 minutes after water consumption. This operation lasts for a week.
Category
Treatment - Other
2
Description
Control group: In the control group, in addition to the usual drug treatment, patients are given 300 ml of refined urban drinking water every four hours daily in bottles similar to the intervention group. Blood oxygenation of all patients is measured by pulse oximetry before and 5 minutes after drinking water. Also, respiration rate per minute of all patients is measured and recorded before and 5 minutes after water consumption. This operation lasts for a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
masoud veissi
Street address
Ahvaz Jundishapur University of Medical Sciences, School of Allied Medicine, Department of Nutrition
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2552
Email
veissi-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
masoud veissi
Street address
Ahvaz Jundishapur University of Medical Sciences, School of Allied Medicine, Department of Nutrition
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2552
Email
veissi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoud Veissi
Position
Assistant of professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Department of Nutrition, School of Allied Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2552
Email
veissi-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoud Veissi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Department of Nutrition, School of Allied Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2552
Email
veissi-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoud Veissi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Department of Nutrition, School of Allied Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
635715794
Phone
+98 61 3311 2552
Email
veissi-m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
If necessary, all data can potentially be shared after unidentified individuals
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted
From where data/document is obtainable
by Email: veissi-m@ajums.ac.ir
What processes are involved for a request to access data/document
Correspondence through academic and scientific institutions