Protocol summary
-
Study aim
-
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
-
The English name of the person in charge of the second sponsor and the address of the city and province of the second sponsor company were also corrected.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201125049486N1
Registration date:
2020-12-24, 1399/10/04
Registration timing:
registered_while_recruiting
Last update:
2021-02-14, 1399/11/26
Update count:
2
-
Registration date
-
2020-12-24, 1399/10/04
-
Registrant information
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Ahvaz University of Medical Sciences
-
Proportion provided by this source
-
50
-
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
2
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Taavony Danesh Bonian Soraya Banoo Company
-
Proportion provided by this source
-
50
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Industry
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
-
Comments
-