The aim of this randomized, double-blind clinical trial is evaluation of the effect of grape seed extract supplement on lipid profile and blood pressure in patients with borderline hyperlipidemia. In this study, 84 patients with hyperlipidemia, who are eligible, are randomly assigned in the intervention or control group. In the intervention group, the patients will receive 200 mg capsules containing grape seed extract and in the control group, the patients receive placebo with the same dose. Blood lipid profile; oxidized LDL, and blood pressure will be measured and compared in two groups after 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107106993N1
Registration date:2011-10-14, 1390/07/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-14, 1390/07/22
Registrant information
Name
Fatemeh Mohammadi Pour
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 1546
Email address
mohammadipor.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Razi Herbal Medicines Research Center, Lorestan University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of grape seed extract (Vitis Vinifera) on lipid profile and blood pressure
Public title
Effect of grape seed extract (Vitis Vinifera) on lipid profile and blood pressure of patients with borderline hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 30-60 years of age, signing informed consent for participation in the study, No known liver disease, renal failure, diabetes mellitus, no pregnancies, not using drugs affecting lipids and blood pressure, first visit to control hyprlipidemia
Exclusion criteria: Having certain medical conditions that require changes in diet and exercise program, Use of other herbal medicine proven effective in reducing blood lipid and blood pressure, Failure to follow instructions and go to the doctor
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
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
Lorestan University of Medical Sciences Research Ethics Committee
Street address
Lorestan University of Medical Sciences, Kamalvand
City
khorram Abad
Postal code
Approval date
2011-06-29, 1390/04/08
Ethics committee reference number
49017/200
Health conditions studied
1
Description of health condition studied
hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
blood lipid profile
Timepoint
before and after the end of study
Method of measurement
meassurement of LDL,HDL,oxidized LDL,HDL,trig
Secondary outcomes
1
Description
hypertension
Timepoint
before and 6 week after study
Method of measurement
measurment of Blood pressure after 15 minutes rest.
Intervention groups
1
Description
Capsules containing 200 mg of grape seed extract for 6 weeks
Category
Treatment - Drugs
2
Description
placebo with the same dose for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer Clinic
Full name of responsible person
Dr Reza Lotfi
Street address
City
Khorram Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi Herbal Medicines Research Center
Full name of responsible person
Dr Bahram Rasoulian
Street address
End Raazi St
City
Khorram Abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Herbal Medicines Research Center
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
School of Nursing and Midwifery, Khorram Abad, Lorestan
Full name of responsible person
Fatemeh Mohammadipour
Position
Faculty Member
Other areas of specialty/work
Street address
Department of Medical- Surgical, School of Nursing and Midwifery