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IRCT20080901001165N65 IRCT 2021-11-10 Tabib daru pharmaceutical company Effectiveness of Detoxil capsules in metabolic syndrome Evaluation of effectiveness and safety of Detoxil capsules in controlling metabolic syndrome: A phase 3, randomized, placebo-controlled, double blind study 2021-08-06 anticipated 100 Complete https://irct.ir/trial/55199 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention, Blinding description: The appearance of drug and placebo capsules will be identical in the study. Only the DSMB and data statistician will be aware of the contents of the capsules. Therefore, other involved people including the researcher, clinical assessor and the participants are not informed of the type of intervention. 3 Metabolic syndrome. 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, artichoke, dandelion and burdock. 60% of the capsule is comprised of artichoke extract and the rest is divided between other three extracts equivalently. Intervention 2: Control group: placebo capsules three times daily for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data release schedule is still unclear.
public Ali Ahmadi
Baqiyatallah university of medical science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 aliahmadi1313@gmail.com Bagheiat-allah University of Medical Sciences scientific Yunes Panahi
Mollasadra St. Vanak Sq. Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8821 1524 yunespanahi@bmsu.ac.ir Baqiyatallah University of Medical Sciences Iran (Islamic Republic of) 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 25 years 75 years Both 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 E88.81 Metabolic syndrome Treatment - Drugs Placebo 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, artichoke, dandelion and burdock. 60% of the capsule is comprised of artichoke extract and the rest is divided between other three extracts equivalently. Control group: placebo capsules three times daily for 12 weeks 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. 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-α. Timepoint: Before and after intervention (12 weeks). Method of measurement: serum levels. Tabib daru pharmaceutical company Approved 2021-06-26 Baqiyatallah Hospital Baqiyatallah Hospital, Sheykh-e-Baha'ee, Sare Mollasadra Tehran Tehran Iran (Islamic Republic of)