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General information
Because the water is provided by Taavony Daneshbonian Soraya Banoo Company, this company was added as another sponsor. In addition, the name of the clinical colleague of the project was added as the responsible person in the patient center section.
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.
Because the water is provided by Taavony Daneshbonian Soraya Banoo Company, this company was added as another sponsor. In addition, theThe English name of the clinical colleagueperson in charge of the project was added assecond sponsor and the responsible person inaddress of the patient center sectioncity and province of the second sponsor company were also corrected.
چون آب مورد نظر توسط شرکت تعاونی دانش بنیان ثریا بانو تامین می گردد،این شرکت نیز به عنوان یکی دیگر از حامیان اضافه گردید.ضمنا در قسمت مرکز بیمار گیری نام همکار بالینی طرح به عنوان فرد مسئول اضافه گردید.
نام انگلیسی فرد مسئول حامی مالی دوم و آدرس شهر و استان شرکت حامی دوم تصحیح گردید.
چون آب مورد نظر توسط شرکت تعاونی دانش بنیان ثریا بانو تامین می گردد،این شرکت نیز به عنوان یکی دیگر از حامیان اضافه گردید.ضمنا در قسمت مرکز بیمار گیری نام همکار بالینی طرح به عنوانانگلیسی فرد مسئول اضافهحامی مالی دوم و آدرس شهر و استان شرکت حامی دوم تصحیح گردید.
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Taavony Danesh Bonian Soraya Banoo Company
Name of organization / entity - Persian: شرکت تعاونی دانش بنیان ثریا بانو
Full name of responsible person - English: Jalil Hashemzadeh
Full name of responsible person - Persian: جلیل هاشم نژاد
Street address - English: Unit 2, No.34, West Roudbar St., Mirdamad Blvd, Tehran, Iran
Street address - Persian: تهران، بلوار میرداماد، خیابان رودبار غربی، پلاک 34، واحد 2
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1911954134
Phone: +98 21 2290 2386
Fax:
Email: Shirinabhz@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Taavony Danesh Bonian Soraya Banoo Company
Name of organization / entity - Persian: شرکت تعاونی دانش بنیان ثریا بانو
Full name of responsible person - English: Jalil Hashemzadeh
Full name of responsible person - Persian: جلیل هاشم زاده
Street address - English: Unit 2, No.34, West Roudbar St., Mirdamad Blvd, Tehran, Iran
Street address - Persian: تهران، بلوار میرداماد، خیابان رودبار غربی، پلاک 34، واحد 2
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1911954134
Phone: +98 21 2290 2386
Fax:
Email: Shirinabhz@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Taavony Danesh Bonian Soraya Banoo Company Name of organization / entity - Persian: شرکت تعاونی دانش بنیان ثریا بانو Full name of responsible person - English: Jalil Hashemzadeh Full name of responsible person - Persian: جلیل هاشم نژادزاده Street address - English: Unit 2, No.34, West Roudbar St., Mirdamad Blvd, Tehran, Iran Street address - Persian: تهران، بلوار میرداماد، خیابان رودبار غربی، پلاک 34، واحد 2 City - English: AhvazTehran City - Persian: اهوازتهران Province: KhouzestanTehran Country: Iran (Islamic Republic of) Postal code: 1911954134 Phone: +98 21 2290 2386 Fax: Email: Shirinabhz@yahoo.com Web page address:
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
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
Department of Nutrition, School of Allied Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
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.