Effectiveness of Detoxil capsules in metabolic syndrome

Phase 3

Recruiting

• Conditions: Metabolic syndrome.; Metabolic syndrome; E88.81

• Registration Number: IRCT20080901001165N65
• Lead Sponsor: Tabib daru pharmaceutical company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.