Evaluation of the effect of Vaccinium arctostaphylos fruit alcoholic extract on serum levels of inflammatory factors in adult patients with hyperlipidemia
The aim of this clinical trial to evaluate the effects of Vaccinium arctostaphylos on hyperlipidemia. Inclusion criteria: Patients serum levels of total cholesterol 200–300 mg/dL and/or triglyceride (TG) 150–199 mg/dL and/or LDL-C 130 130–190 mg/dL. 40 patients with hyperlipidemia over of 18 years will be randomly divided into two treatment groups and control. In the treatment group take two tablets daily capsule of Vaccinium arctostaphylos, and in the control group take two placebo capsule for a month. At the beginning and end of a month will collect of blood samples for determination of ICAM-1, VCAM-1, IL-6, TNFα lavel. Also, determine the possible effect of the drug on liver and renal function Cr and ALT and AST liver enzymes to be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507309662N10
Registration date:2015-09-16, 1394/06/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
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
Isfahan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Vaccinium arctostaphylos fruit alcoholic extract on serum levels of inflammatory factors in adult patients with hyperlipidemia
Public title
Vaccinium arctostaphylos fruit on levels of inflammatory factors in adult patients with hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/exclusion criteria: age over of 18 years; serum levels of total cholesterol 200–300 mg/dL and/or triglyceride (TG) 150–199 mg/dL and/or LDL-C 130 130–190 mg/dL; being non-smokers; free of diseases affecting serum lipids (e.g., diabetes, thyroid disorders, and pancreatitis); not using drugs or supplements affecting serum lipids (e.g., statins, fibrate derivatives, estrogens, progestins, beta-blockers, thiazide diuretics, and fish oil) within the last 3 months; free of liver or kidney disease; nonpregnant, nonlactating women
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jirib St. Isfahan, Iran
City
Isfahan
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
393079
Health conditions studied
1
Description of health condition studied
Pure hypercholesterolaemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolaemia
2
Description of health condition studied
Hyperlipidaemia, unspecified
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
3
Description of health condition studied
Other disorders of lipoprotein metabolism
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism
Primary outcomes
1
Description
Intercellular adhesion molecule-1
Timepoint
Before and after one Month
Method of measurement
ELISA Kit
2
Description
vascular cell adhesion molecule-1
Timepoint
Before and after one Month
Method of measurement
ELISA Kit
3
Description
IL-6
Timepoint
Before and after one Month
Method of measurement
ELISA Kit
4
Description
TNF-α
Timepoint
Before and after one Month
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Weight
Timepoint
Before and after 4 weeks
Method of measurement
scale
2
Description
Creatinine level
Timepoint
Before and after One Month
Method of measurement
ELISA Kit
3
Description
Urea levels
Timepoint
Before and after One Month
Method of measurement
ELISA Kit
4
Description
Liver enzyme ALT
Timepoint
Before and after One Month
Method of measurement
ELISA Kit
5
Description
Liver enzyme AST
Timepoint
Before and after One Month
Method of measurement
ELISA Kit
Intervention groups
1
Description
control group: take placebo capsol twice a day for a month
Category
Placebo
2
Description
case group: take Vaccinium arctostaphylos capsol twice a day for a monthr
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Mahtab Keshvari
Street address
Khorram Street, Jomhori Square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of 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
Vice Chancellor for research of Isfahan 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
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 3335 9595
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
MS / MS Research
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 3335 9595
Fax
Email
mahtabkeshvari87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)