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Evaluation of oral product of Carthamus tinctorius effect on cardiovascular risk factors among metabolic syndrome patients

Protocol summary

Study aim
Determination of the effect of edible safflower seeds on cardiovascular risk factors in patients with metabolic syndrome and introducing this product as a useful food product in the field of treatment in the case of proven efficacy
Design
َA Clinical trials, block method randomized, two parallel groups of 45 which double-blinded will begin in June 2018 and over after 10 months
Settings and conduct
The study will be conducted in Shiraz. Intervention group patients will receive 8 safflower capsules, every 6 hours a day. Alongside, placebo group patients will receive same number of paraffin capsules with same frequency. Intervention will be continued for 12 consecutive weeks. Participants will be followed up monthly by telephone or re-visiting. Patients and physician are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed and written consent to participate in the study Body mass index (BMI) above 27 Having three signs of the five features of metabolic syndrome based on NCEP-ATPIII definitions Exclusion criteria: Use of out-of-protocol treatments Use of drugs associated with the treatment of metabolic syndrome in the past month Sensitivity to safflower seeds Kidney, liver, cancer, thyroid and/or coagulation disease Pregnancy and/or lactation Tobacco use, alcohol and/or substance abuse Taking anti-platelet and anticoagulant drugs (such as aspirin, clopidogrel, warfarin, etc.)
Intervention groups
The intervention and placebo group will receive safflower and paraffin capsules, respectively, for 12 weeks.
Main outcome variables
Changes in serum total cholesterol, LDL, HDL, TG, FBS, insulin levels, leptin levels, adiponectin levels, AST, ALT, systolic and diastolic blood pressure, WHR and BMI, frequency of bowel habit and stool consistency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180515039673N1
Registration date: 2018-08-01, 1397/05/10
Registration timing: registered_while_recruiting

Last update: 2018-08-01, 1397/05/10
Update count: 0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Maede Ruyvaran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 5145
Email address
ruyvaran@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral product of Carthamus tinctorius effect on cardiovascular risk factors among metabolic syndrome patients
Public title
Effect of safflower oral product in treatment of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent for participation in the study / Body mass index (BMI) above 27 / Having three signs of the five characteristics of the metabolic syndrome based on the definitions of NCEP-ATPIII
Exclusion criteria:
Use of extra- protocol treatments / Use of drugs associated with treatment of metabolic syndrome in the past month / Safflower allergy /positive history of kidney, liver, cancer, thyroid and/or coagulation disease / pregnancy and/or lactation / smoking, alcohol and/or substance abuse / Taking anti-platelet and anticoagulant drugs (such as Aspirin, Clopidogrel, Warfarin, etc.)
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is block type along with using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, the drug delivery officer, physician and the statistical analyst of the results, will be blind, and only the drug manufacturer can decode based on the original form of randomization.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Medical school, Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.SUMS.MED.REC.1397.058

Health conditions studied

1

Description of health condition studied
Metabolic syndrome includes pre-diabetes, dyslipidemia, overweight and obesity and hypertension
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Percentage of people with hypertension
Timepoint
Measuring hypertension at the beginning of the study (before the intervention) and 1, 2 and 3 months after the onset of intervention.
Method of measurement
Automated sphygmomanometer

Secondary outcomes

1

Description
Composition of body components
Timepoint
Measurement at the beginning of the study (before the intervention) and 12 weeks after intervention
Method of measurement
Medical body Composition Analyzer

Intervention groups

1

Description
Intervention group: One gram capsules made by Barij-Essence Pharmaceutical Company contains safflower oil, which 8 of them will be given daily with 6-hour intervals for next 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: One gram capsules made by Barij-Essence Pharmaceutical Company contains liquid paraffin, which 8 of them will be given daily with 6-hour intervals for next 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
Maede Ruyvaran
Street address
Namazi squere
City
Shiraz
Province
Fars
Postal code
0000000
Phone
+98 71 3612 1000
Email
Ruyvaran@sums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Faghihi clinic
Full name of responsible person
Maede Ruyvaran
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
Ruyvaran@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Central building, Zand street
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
nimroozi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nothing
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maede ruyvaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional medicine department, Medical school, Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Email
ruyvaran@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maede ruyvaran
Position
Ph.d candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional medicine department, Medical school, Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Email
ruyvaran@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maede ruyvaran
Position
Ph.d candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional medicine department, Medical school, Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Email
ruyvaran@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure such as physical examination changes and laboratory findings only.
When the data will become available and for how long
starting 12 months after publication.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
There is not any decision yet.
From where data/document is obtainable
Contact with main researcher
What processes are involved for a request to access data/document
After correspondence with the researcher, within the framework of the declarations and in the shortest possible time
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