Aims: The aim of this study is to compare the effect of Descurainia Sophia use alongside levostatin on LDL cholesterol reduction for the first time.
Design: In this double - blind clinical trial, the effect of Descurainia Sophia with levostatin compared with the effect of levostatin on LDL cholesterol reduction will be studied in cardiovascular patients.
Setting and conduct: 80 cardiovascular patients referring to the heart clinic of Shohada Ashayer hospital of Khorramabad city with high serum cholesterol level, whose disease will be approved by cardiologist. Then the patients will be divided into two groups of intervention and control. All the patients will sign the informed consent form and their serum cholesterol will be measured before and 5 months after intervention.
Participants including major eligibility: The participants are cardiovascular patients with high cholesterol, who will randomly be divided into two groups by stratified sampling method.
Inclusion criteria: high cholesterol level; aged between 40-70 years.
Exclusion criteria: Patients using anti- lipids or steroids and stain; patients with diabetes and nephritic syndrome.
Intervention: The patients will be divided into two groups randomly. Intervention group will receive 20mg of levostatin with dinner and 8 grams of Descurainia Sophia per day before lunch. The control group will receive 20mg of levostatin with dinner and placebo every day before lunch. The interventional time is 5 months for both groups.
Main outcome measures: change in LDL cholesterol
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012612277N1
Registration date:2014-01-27, 1392/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Mahnaz Mardani
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0147
Email address
mardani.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The cholesterol-lowering effect of Descurainia sophia
Public title
Comparing the effect of levostatin + Descurainia sophia and levostatin in lowering LDL cholesterol in patients with cardiovascular disease, A Clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: cardiovascular patients; aged between 40 to 70 years; LDL cholesterol more than 160 miligram/dl
Exclusion criteria: taking anti - lipids, steroids or statins; suffering from diabetes, hypothyroids and nephritic syndrome
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will randomly be divided into two groups, by stratified sampling method. The study will be double blind. Patients and bioinformatics coworker do not know about type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
3rd kilometer of Khorramabad- Boroujerd Road, Pardiss Complex of Education
City
Khorramabad
Postal code
6814993165
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
79123/200
Health conditions studied
1
Description of health condition studied
Cardiovascular diseases
ICD-10 code
170
ICD-10 code description
Atherosclerosis
2
Description of health condition studied
cardiovascular diseases
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolaemia
Primary outcomes
1
Description
Change in LDL cholesterol
Timepoint
Before intervention and 5 months after intervention
Method of measurement
With Liberman- Buchard method
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Intervention group will take levostatin+ Descurainia sophia, that patients will take 20mg levostatin with diner+8 grams of Descurainia Sophia in 8 capsule per day with lunch for 5 months.
Category
Treatment - Drugs
2
Description
Control group:Control group will take levostatin+ placebo, that patients will take 20mg levostatin with diner+ 8 empty capsule as placebo per day with lunch for 5 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Herbal Medicine Research Center
Full name of responsible person
Dr Mahnaz Mardani
Street address
Razi Street
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Lorestan University of Medical Sciences
Full name of responsible person
Dr Mohamad Hasan Kayedi
Street address
3rd kilometer of Khorramabad-Boroujerd Road, Pardis complex of education
City
Khorramabad
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 Lorestan 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
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Mardani
Position
PhD of Nutrition/ Associate professor
Other areas of specialty/work
Street address
3rd kilometer of Khorramabad- Boroujerd road, Pardiss complex of education
City
khorramabad
Postal code
6814993165
Phone
+98 66 1620 0147
Fax
+98 66 1620 0149
Email
msmardani@yahoo.com; mardani_m@lums.ac.ir
Web page address
http://www.lums.ac.ir;
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Mardani
Position
PhD of Nutrition/ associate professor
Other areas of specialty/work
Street address
3rd kilometer of Khorramabad- Boroujerd road, Pardiss complex of education
City
Khorramabad
Postal code
6814993165
Phone
+98 66 1620 0147
Fax
+98 66 1620 0149
Email
mardani.m@lums.ac.ir; msmardani@yahoo.com
Web page address
http://www.lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Mardani
Position
PhD of nutrition
Other areas of specialty/work
Street address
3rd kilometer of Khorramabad - Boroujerd road, Pardiss complex of education
City
khorramabad
Postal code
6814993165
Phone
+98 66 1620 0147
Fax
+98 66 1620 0149
Email
mardani.m@lums.ac.ir; msmardani@yahoo.com
Web page address
http://www.lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)