In this double-blind, placebo, Randomized controlled clinical trial study in hyperlipidemic patients 90 volunteers, subjects aged 35–70 years and over 5/18 mM cholesterol (200 mg per deciliter), and over 3/ 37mM LDL (130 mg dL) will be selected. The purpose of this study, is to investigate the effect of jujube fruits (Ziziphus vulgaris L.) extract capsule On, Inflammatory factor (hs-CRP) levels, the lipid profile, Apolipoprotein A B and blood sugar levels in hyperlipidemic patients. Individuals with a history of diseases; diabetes; cardiovascular disease; liver and kidney as well as pregnant and breastfeeding; supplements like fish oil which is affect on blood lipids levels; the use of immunosuppressive drugs will be excluded. Inflammatory factor (hs-CRP) levels, the lipid profile, Apolipoprotein A B and blood sugar levels will be measured using ELISA kits. Participants will be randomly divided into three groups. Group1 will consume 2 jujube fruits extract capsule(500mg). Group2 will consume 2 placebo capsule and Group3 will take A tablet to atorvastatin(20mg) 4 weeks. Then at the beginning and end of each 4-week period aforementioned factors will be measured again for each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308319662N7
Registration date:2013-09-23, 1392/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Isfahan Cardiovascular Research Center ,Isfahan Cardiovascular Research institute , Physiology Re
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
s_asgari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Isfahan University of Medical Sciences
2 - Razi Herbal Research Center, Lorestan University of Medical Sciences
Expected recruitment start date
2013-11-21, 1392/08/30
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of jujube fruits on lipid profile in hyperlipidemic patients
Public title
Effects of jujube fruits on lipid profile in hyperlipidemic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
in hyperlipidemic patients; subjects aged 35–70 years ; over 5/18 mM cholesterol (200 mg per deciliter); over 3/ 37mM LDL (130 mg dL).
exclusion criteria :
Individuals with a history of diseases; diabetes; cardiovascular disease; liver and kidney as well as pregnant and breastfeeding; supplements like fish oil which is affect on blood lipids levels; the use of immunosuppressive drugs
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Razi Herbal Medicines Research Center, Lorestan
Street address
St.shafa (Razi), Vice Chancellor for Research and Technology - Razi Herbal Medicines Research Center
City
Khorramabad
Postal code
Approval date
2013-06-09, 1392/03/19
Ethics committee reference number
92/5
Health conditions studied
1
Description of health condition studied
Other disorders of lipoprotein metabolism
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism
2
Description of health condition studied
Pure hypercholesterolaemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolaemia
3
Description of health condition studied
Hyperlipidaemia, unspecified
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
total cholestrol
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
2
Description
HDL
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
3
Description
LDL
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
4
Description
TG
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
Secondary outcomes
1
Description
hs-CRP
Timepoint
Before and after 4 weeks
Method of measurement
ELISA Kit
2
Description
apo A
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
3
Description
apo 8
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
4
Description
FBS
Timepoint
Before and after 4 weeks
Method of measurement
Parss Azmon KIT/Device Hitachi
Intervention groups
1
Description
control group: take placebo capsol twice a day after the lunch and dinner for a month
Category
Placebo
2
Description
case group: take Ziziphus vulgaris capsol twice a day after the lunch and dinne for a monthr
Category
Treatment - Drugs
3
Description
case group: taking one Atorvastatin Tableta day after the lunch and dinner
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research CenterSedigheh Tahereh
Full name of responsible person
Mahtab Keshvari
Street address
Khorram Street, Jomhori Square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
RAZI Research Center Lorestan University of Medical Sciences
Full name of responsible person
Dr.Bahram Rasoulian
Street address
Shafa St.(Razi) - Vice Chancellor for Research and Technology
City
khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
RAZI Research Center Lorestan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.gholam hossin sadri
Street address
Hezar jirib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
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
Isfahan Cardiovascular Research Center, Applied Physiology Research Center, Isfahan University of Me
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Cardiovascular Research Center, Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
sasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Mahtab keshvari
Position
MSc / BSc Research
Other areas of specialty/work
Street address
Cardiovascular Research Center, Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
mahtabkeshvari87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)