Objective: To determine the effect of oral administration of thyme honey on anemia and some cardiovascular risk factors in hemodialysis' patients. Inclusion criteria: Desire to participate and giving the written consent; treatment with hemodialysis 3 times a week for 3 hours or more per session and for more than 3 months; not being diagnosed with cancer; mental disability; liver failure and not being allergic to honey. Exclusion criteria: Hospitalization and changes in the patient's medications during the study. Population under Study: hemodialysis' patients of Kowsar hospital in Semnan. Sample size: A pilot study including 10 patients in each group, the size of samples will be estimated. Considering the three variables of age (less than 50 or greater than 50), sex (male or female) and diabetes diagnosis (or not), entered into 8 possible groups, and then the subjects of each group were randomly allocated to intervention or control groups via the flip the coin. Intervention group: Intervention group will use 33 grams of thyme honey on each morning shift on a daily bases for one month. Control group: The control group will undergo routine care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705266318N9
Registration date:2017-07-01, 1396/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral administration of thyme honey on anemia and some cardiovascular risk factors in hemodialysis patients
Public title
The effect of oral administration of thyme honey on anemia and some cardiovascular risk factors in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Desire to participate and giving the written consent; treatment with hemodialysis 3 times a week for 3 hours or more per session and for more than 3 months; not being diagnosed with cancer; mental disability; liver failure and not being allergic to honey. Exclusion criteria: Hospitalization and changes in the patient's medications during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Semnan University of Medical sciences
Street address
Semnan University of Medical Sciences, Basij Blv., Semnan
City
Semnan
Postal code
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.4
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Hemoglobin
Timepoint
Before the intervention; one month after intervention
Method of measurement
In this study, hemoglobin is measured with Cell take E.
Secondary outcomes
1
Description
Hematocrit
Timepoint
Before the intervention; one month after intervention
Method of measurement
In this study, hematocrit is measured with Cell take E.
2
Description
Lipids
Timepoint
Before the intervention; one month after intervention
Method of measurement
In this study, lipids are measured with Pars test.
3
Description
C- reactive protein
Timepoint
Before the intervention; one month after intervention
Method of measurement
In this study, C-Reactivate protein is measured with bionik vial.
4
Description
Glucose
Timepoint
Before the intervention; one month after intervention
Method of measurement
In this study, glucose is measured with Pars test.
Intervention groups
1
Description
Intervention group: Intervention group will use 33 grams of thyme honey on each morning shift on a daily bases for one month.
Category
Prevention
2
Description
Control group: The control group will undergo routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Monir Nobahar
Street address
Al-Ghadir Sq., Golestan town, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidypour
Street address
Semnan University of Medical Sciences, Basij Blv, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Monir Nobahar
Position
Associated professor of Semnan University of Medical Sciences
Other areas of specialty/work
Street address
Faculty Nursing and Midwifery, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4170
Fax
Email
Nobahar43@semums.ac.ir; Nobahar43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Monir Nobahar
Position
PhD Nursing
Other areas of specialty/work
Street address
Faculty Nursing and Midwifery, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4170
Fax
Email
Nobahar43@semums.ac.ir; Nobahar43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Monir Nobahar
Position
Associated professor of Semnan University of Medical Sciences
Other areas of specialty/work
Street address
Faculty Nursing and Midwifery, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4170
Fax
Email
Nobahar43@semums.ac.ir; Nobahar43@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)