Determining Effect of Dairy Product of Donkey milk on the Clinical Course of Symptoms of COVID_19 Outpatients
Design
Randomized clinical trial with parallel intervention and control groups
Settings and conduct
Patients with mild to moderate illness are candidates for quarantine and receiving this treatment at home after a visit to the clinics designated by the Department of Health for COVID-19
Participants/Inclusion and exclusion criteria
Patients with COVID-19 with mild to moderate severity according to the protocol of the Ministry of Health, are candidates for outpatient treatment; aged 18-65 years. Patients with allergies and asthma, hypertension, diabetes, pregnancy / lactation, heart failure, chronic renal failure, undergoing chemotherapy, receiving corticosteroids and having a defective immune system are not included in the study.
Intervention groups
Intervention group: receiving medicine for the treatment of COVID-19 according to the protocol of the Ministry of Health along with receiving dairy product of Donkey milk. Control group: receiving medicine for the treatment of COVID-19 according to the protocol of the Ministry of Health.
Main outcome variables
Clinical status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161108030776N3
Registration date:2020-08-26, 1399/06/05
Registration timing:prospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Mohadese Kamali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2827
Email address
mohadesekamali0912@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dairy product donkey milk on the course of signs of patients with suspected corona disease (COVID-19)
Public title
Effect of donkey milk on the new corona virus infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19
Mild to moderate disease
Candidates for outpatient treatment based on the protocol of the Ministry of Health
Patients 18-65 years old
Exclusion criteria:
Patients with allergies and asthma
Patients with hypertension
Patients with diabetes
Pregnancy / lactation
Patients with heart failure
Patients with chronic renal failure
Patients undergoing chemotherapy
Patients receiving corticosteroids
Patients with immunodeficiency
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
First, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through random allocation software, in the same random order, patients will be divided into two groups of test and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
campus of University of Medical Sciences, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.KMU.REC.1399.321
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Body temperature
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Mercury thermometer
2
Description
Cough (severity-frequency)
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Fiston Scale
3
Description
Weakness and lethargy
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Visual analog scale (VAS)
4
Description
Body pain
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Visual analog scale (VAS)
5
Description
Breathing speed
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Count the number of breaths per minute
6
Description
Diarrhea (watery stools)
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Question from the patient
Secondary outcomes
1
Description
Being admitted to the hospital
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
The ratio of the number of cases leading to hospitalization to the total number of patients in each group
2
Description
Death rate
Timepoint
Days 0-1-2-3-4-7-14 after the start of the intervention
Method of measurement
Ratio of number of deaths to total patients in each group
Intervention groups
1
Description
Intervention group: In addition to drug treatment according to the protocol of the Ministry of Health, patients in this group receive donkey milk at a rate of 300 cc daily with 5 grams of candy for 5 days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive medication according to the protocol of the Ministry of Health.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Haleh Tajadini
Street address
Afzalipour hospital, next to Bahonar University, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
+98 34 1211 3426
Email
dr_haleh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Deputy of Research and Technology, beginning of Ibn Sina Street, Somayeh Intersection (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Haleh Tajadini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
dr_haleh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Haleh tajadini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
dr_haleh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
mohadesekamali0912@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome will be published after the end of the study.
When the data will become available and for how long
Immediately after publishing the article
To whom data/document is available
All researchers
Under which criteria data/document could be used
The data and results can be used by all researchers for research in the fields related to this study.