The effect of Ziziphus jujuba syrup on high blood hemoglobin and hematocrite in polycythemia patient
Design
The study is a before and after clinical trial. This study is performed on patients with high blood concentrations. The statistical population is based on similar studies is about 50 individuals. Repeated measures ANOVA is used to compare Mean±SD in 3 times( before treatment,1 and 2 months after treatment.All data will be analyzed by SPSS software.
Settings and conduct
The plan will be carried out in the Oncologist's office.
Patients will be enrolled the plan after doing first CBC test and consulting a physician, if they meet the inclusion criteria.Two cans of jujube syrup will be given for one month.
How to take the medicine: Take 1 tablespoon of syrup before each meal.
During treatment, a person contact with patient to record data and possible drug side effects.
Patients are re-examined after one month. Also second CBC test is performed, according to results. The patient is given 2 cans of jujube syrup.
After two months of initial visit, the final visit is performed, and the final CBC test is performed after taking two months of syrup.
Finally, the data obtained from the 2 month survey are recorded in the software for data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with hemoglobin above 16 g/dl in women and above 17 g/dl in men
Exclusion criteria: Pregnant and lactating women, people with embolism, myocardial infarction. Drug sensitivity, emergency conditions
Intervention groups
All patients will be given syrup
Main outcome variables
Changes in blood hemoglobin concentration
Changes in blood hematocrit concentration
Change in the number of red blood cells
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046087N1
Registration date:2020-01-27, 1398/11/07
Registration timing:prospective
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Hanieh Babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
haniehbabaei92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ziziphus jujuba syrup on high blood hemoglobin and hematocrite in polycythemia patient
Public title
Effect of jujube syrup on blood concentration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with blood concentrations (hemoglobin above 16 g / dL in women and above 17 g / dl in men)
Not having high blood concentration
No history of embolism, myocardial infarction or stroke
Exclusion criteria:
Drug side effects, sensitivity and ...
Emergency conditions in the patient
Pregnancy and lactation
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
3
Patient's blood hemoglobin level
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.492
Health conditions studied
1
Description of health condition studied
blood concentration (polycythaemia)
ICD-10 code
D75.1
ICD-10 code description
Secondary polycythemia
Primary outcomes
1
Description
blood hemoglobin level
Timepoint
Before starting the study and 1 month after entering the plan and at the end of the study
Method of measurement
blood sample
2
Description
blood hematocrit level
Timepoint
Before starting the study and 1 month after entering the plan and at the end of the study
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before each meal, take a spoonful of syrup(5 cc). The syrup contains jujube.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The office of Dr. Behrouz Gharib
Full name of responsible person
Behrouz Gharib
Street address
No. 121, Next to Al-Ghadir Mosque, Mirdamad Street, ,
City
Tehran
Province
Tehran
Postal code
1911617813
Phone
+98 21 2290 9058
Email
Gharib.behrooz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Esmaeili
Street address
NO.8, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor, Faculty of Traditional Medicine, Shahid Beheshti University
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor, Faculty of Traditional Medicine, Shahid Beheshti University
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Babaei
Position
reasercher
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
haniehbabaei92@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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The questionnaires used and the information about the main outcome after the 3 months of publication of the results are shared with the applicants.
When the data will become available and for how long
3 months after publishing results
To whom data/document is available
researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
What processes are involved for a request to access data/document
After 18 months of sampling (for 50 samples: approx. 18 months),oncologist visit and take drugs, 2 months of statistical analysis and 3 months after printing results It takes about 24 months to complete.
Information is provided to the applicant.