In this clinical trial study patients are recruited from Clinic of Internal Medicine. Patients with low density lipoprotein cholesterol (LDL-C) over than 120 mg/dl are included in the study and divided in three groups (Cumin, Purslane and lovastatin). These patients are matched for age, gender, exercise and smoking. A fasting venous blood sample is obtained from all participants before initiating treatment and a second sample after a mean of 45 days of treatment. Total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C), LDL-C, apolipoprotein A1 (Apo A1), apolipoprotein B (Apo B), arylesterase activity and PON1 activity toward paraoxon and the oxidised LDL (oxLDL) are measured before and 45 days after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902063806N1
Registration date:2010-04-21, 1389/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-21, 1389/02/01
Registrant information
Name
Effat Farrokhi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 6692
Email address
farrokhi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord university of medical sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Portulaca Oleracea and Cumin effects on serum paraoxanase 1 activity
Public title
Study of Portulaca Oleracea and Cumin effects on serum paraoxanase 1 activity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with low density lipoprotein cholesterol (LDL-C) over than 120 mg/dl. Exclusion criteria: patients with metabolic disease such as diabetes mellitus, renal diseases and individuals taking lipid lowering or anti hypertension drug.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord university of medical sciences
Street address
Kashani street
City
Shahrecord
Postal code
Approval date
2009-02-20, 1387/12/02
Ethics committee reference number
87-10-1
Health conditions studied
1
Description of health condition studied
Metabolic disorders
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias
Primary outcomes
1
Description
Paraxonase1
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
Apo A1
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
2
Description
Apo B
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
3
Description
Cholesterol
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
4
Description
Triglyceride
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
5
Description
HDL
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
6
Description
LDL
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
7
Description
OX LDL
Timepoint
before and after 45 days of intervention
Method of measurement
blood sample
Intervention groups
1
Description
Purslane , Almost 50 grams/day of fresh leaves and stems of Purslane, 45 days
Category
Treatment - Other
2
Description
Cumin extract, 1ml of 2% based on manufacturing recommendation , 45 days
Category
Treatment - Drugs
3
Description
Lovastatin, 20mgs/day oral, 45 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord internal clinic, No. 2
Full name of responsible person
Street address
City
Shahrecord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Kashani street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord university of medical sciences
Full name of responsible person
Beheshteh Amiri
Position
nursing
Other areas of specialty/work
Street address
Cellular and molecular research center, Faculty of medicin, Rahmatieh
City
Shahrekord
Postal code
Phone
+98 38 1334 6692
Fax
Email
e_farrokhi_k@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrecord university of medical sciences
Full name of responsible person
Dr keihan Ghatreh Samani
Position
PhD in Biochemistry
Other areas of specialty/work
Street address
Biochemistry department, Faculty of medicine, Rahmatieh
City
Shahrekord
Postal code
Phone
+98 38 1333 5654
Fax
Email
kgsamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)