Metabolic syndrome. Metabolic syndrome
Conditions
Interventions
Intervention 1: Intervention group: Detoxil capsule three times daily for 12 weeks. Detoxil capsules were manufactured in Tabib Darou company and contain the hydroalcoholic extracts of milk thistle, a
Sponsors
Tabib daru pharmaceutical company
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patient should have read and signed the informed consent form Patient should fulfill the criteria of NCEP ATP III for metabolic syndrome by having at least three items out of the following: 1- Fasting blood glucose higher than 100 mg/dL; 2- triglyceride level higher that 150 mg/dL; 3- HDL level lower than 40 mg/dL for men and 50 mg/dL for women; 4- systolic blood pressure higher than 130 mmHg or diastolic blood pressure higher than 85 mmHg; 5- waist circumference bigger than 102 cm for men and 94 cm for women
Exclusion criteria
Exclusion criteria: Pregnancy Lactation Participation at a concurrent clinical trial History of allergic reaction to any of the ingredients of drug Active malignancy Severe hepatic or renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure. Timepoint: Before and after intervention (12 weeks). Method of measurement: mmHg.;Triglyceride. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;LDL. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;HDL. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;Total cholestrol. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;FBS. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;HbA1c. Timepoint: Before and after intervention (12 weeks). Method of measurement: serum levels.;Weight. Timepoint: Before and after intervention (12 weeks). Method of measurement: kg.;Waist circumference. Timepoint: Before and after intervention (12 weeks). Method of measurement: cm.;Fatty liver disease stage. Timepoint: Before and after intervention (12 weeks). Method of measurement: Ultrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI. Timepoint: Before and after intervention (12 weeks). Method of measurement: kg/m2.;ALT. Timepoint: Before and after intervention (12 weeks). Method of measurement: U/L.;AST. Timepoint: Before and after intervention (12 weeks). Method of measurement: U/L.;ALP. Timepoint: Before and after intervention (12 weeks). Method of measurement: U/L.;Total bilirubin. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;Direct bilirubin. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/dL.;MDA. Timepoint: Before and after intervention (12 weeks). Method of measurement: nmole/mL.;SOD. Timepoint: Before and after intervention (12 weeks). Method of measurement: IU/mL.;Leptin. Timepoint: Before and after intervention (12 weeks). Method of measurement: ng/mL.;Adiponectin. Timepoint: Before and after intervention (12 weeks). Method of measurement: µg/mL.;IL-6. Timepoint: Before and after intervention (12 weeks). Method of measurement: serum levels.;IL-8. Timepoint: Before and after intervention (12 weeks). Method of measurement: serum levels.;CRP. Timepoint: Before and after intervention (12 weeks). Method of measurement: mg/L.;TNF-a. Timepoint: Before and after intervention (12 weeks). Method of measurement: serum levels. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Ahmadi
Bagheiat-allah University of Medical Sciences
Outcome results
None listed