Effect of safflower oral product in treatment of metabolic syndrome
Phase 3
Recruiting
- Conditions
- Metabolic syndrome includes pre-diabetes, dyslipidemia, overweight and obesity and hypertension.E88.81Metabolic syndrome
- Registration Number
- IRCT20180515039673N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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.)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.