The main aim of this study is to determine the effects of food products based on Traditional Persian Medicine on hemorheology in polycythemia. The study is a single blind randomized clinical trial on male patients with polycythemia aged 35-60 years without underlying disease, who have not received drug two weeks before entering the study. Those with a history of underlying disease or specific illness, the habit of smoking cigarettes, tobacco and narcotics, or food allergies are excluded. The total number of 40 patients is taken into account that randomly will be divided into two groups: intervention and control. The control group will be received only routine treatment (Phlebotomy) and intervention group will be used the diet in addition to standard treatment (Phlebotomy). The diet without sticky foods, matched two weeks before entering the study in both candidates, and will continue during the study period (6 weeks). The main intervention of this study is diet that is served as dinner and until two hours after, is no longer used for food. One's daily consumption is determined by BMI. The main outcome measure of the study is blood fluidity and related consequences outcome is laboratory tests included CBC, lipid profile, plasma fibrinogen, plasma osmolality and FBS. Candidates are tested at twice. The first time before entering the study and the second time after the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111024993N1
Registration date:2015-12-04, 1394/09/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-04, 1394/09/13
Registrant information
Name
Hamideh Naghedi Baghdar
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
naghedih911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effects of Food Products Based on Traditional Persian Medicine on Hemorheology in Polycythemia
Public title
Effects of Food Products on Hemorheology
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male patients; polycythemia without underlying disease; age range 35-60 years; no medication two weeks before entering the study
Exclusion criteria: food allergy; history of the underlying disease; history of experience disease; history of drug use before entering the study; Smoking a cigarette, tobacco and narcotics; lack of consent to continue the project; the possible incidence of side effects
Age
From 35 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences Administration, Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
9138813944
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC.1394.496
Health conditions studied
1
Description of health condition studied
polycitemia
ICD-10 code
D75
ICD-10 code description
Other diseases of blood and blood-forming organs
Primary outcomes
1
Description
Blood fluidity
Timepoint
Baseline, the end of the study
Method of measurement
R/S-CC Plus Coaxial Cylinder Rheometer Brookfield-type
Secondary outcomes
1
Description
CBC
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test
2
Description
Lipid profile
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test
3
Description
Plasma fibrinogen
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test
4
Description
Plasma osmolality
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test
5
Description
FBS
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test
Intervention groups
1
Description
Control group: phlebotomy only in the beginning of the study
Category
Treatment - Other
2
Description
Intervention group: diet for 6 weeks in addition to phlebotomy at baseline. This diet is served as dinner and until two hours after, is no longer used for food. One's daily consumption is determined by BMI in such a way that people with a BMI less than 20, 350 grams daily, people with a BMI between 20 and 30 daily 400 grams and people with a BMI greater than 30 received daily 450 grams of this food. Ingredients in the preparation of the foods weighed and packed with recipes based on the amount determined, as it is for the patients. During the study period is 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Easar health clinics affiliated to hospital of Imam Reza
Full name of responsible person
Hamideh Naghedi Baghdar
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellory of Mashhad 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Nazari
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
tim@mums.ac.ir Nazarim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Naghedi Baghdar
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhdd
Postal code
Phone
+98 51 3855 2188
Fax
Email
naghedih911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)