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Study aim
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Evaluation of effectiveness and safety of Detoxil capsules in controlling metabolic syndrome
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Design
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A double-blind, randomized, placebo-controlled, parallel phase 3 clinical trial.
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Settings and conduct
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In this study, a total of 100 patients will participate who meet the inclusion criteria and who have given conscious and free consent for participation. The patients will be randomly divided into control and intervention groups in Baqiyatallah clinic. The duration of the study will be 12 weeks. Blood sampling, liver ultrasonography and anthropometric evaluation will be performed before and after intervention and the results will be analyzed with the help of SPSS.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age: between 25 and 75 years; The patient have written consciously and freely consent to participate in the study; 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: History of allergy to this drug ingredients; The patient is in another clinical trial at the same time; active malignancies; severe hepatic or renal disease; Pregnancy; Lactation.
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Intervention groups
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Control group: placebo drug, 1 capsule three times daily for 12 weeks
Intervention group: Detoxil drug, 1 capsule three times daily for 12 weeks
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Main outcome variables
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Biomarker levels in blood (LDL,HDL,TG, Total Cholesterol, FBS, A1C, ALT, AST, Bilirubin total & direct, ALK, CRP, TNF-α, IL-6, IL-8, leptin, adiponectin, SOD, MDA); liver fatty disease stage; weight; waist circumferenc; BMI