| Trial ID: | L0552 |
| Source ID: | IRCT201701172709N44
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| Associated Drug: |
Purslane
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| Title: |
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;K76.0
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| Interventions: |
Intervention 1: Intervention group: consumption of one capsule per day (containing 300 mg hydroethanolic extract of purslane) for 12 weeks. Intervention 2: Control group: consumption of one placebo capsule for 12 weeks.
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| Outcome Measures: |
Alanine aminotransferase (ALT). Timepoint: At the begining and at the end of week 12. Method of measurement: Laboratory kit.;Aspartate aminotransferase (AST). Timepoint: At the begining and at the end of week 12. Method of measurement: Laboratory kit.Weight. Timepoint: At the begining and at the end of week 12. Method of measurement: Seca scale.;Body mass index (BMI). Timepoint: At the begining and at the end of week 12. Method of measurement: Calculation: weight (in kilograms) divided by the square of height (in meters).;Waist circumference. Timepoint: At the beginning and at the end of week 12. Method of measurement: Non-stretchable measuring tape.;Liver steatosis. Timepoint: At the beginning and at the end of week 12. Method of measurement: Sonography.;Systolic blood pressure (SBP). Timepoint: At the beginning and at the end of week 12. Method of measurement: Sphygmomanometer.;Diastolic blood pressure (DBP). Timepoint: At the beginning and at the end of week 12. Method of measurement: Sphygmomanometer.;Total cholesterol. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Triglyceride (TG). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;High density lipoprotein (HDL). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Low density lipoprotein (LDL). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Albumin (ALB). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Alkaline phosphatase (ALP). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Gamma glutamyl transferase (GGT). Timepoint: At the begining and at the end of week 12. Method of measurement: Laboratory kit.;Total bilirubin. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Fasting blood sugar (FBS). Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit.;Insulin. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit (ELISA).;Homeostatic model assessment of insulin resistance (HOMA-IR). Timepoint: At the beginning and at the end of week 12. Method of measurement: Calculation: [fasting insulin (mU/L) * fasting blood glucose (mg/dl)]/405.;Glutathione peroxidase activity. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit (ELISA).;Adiponectin. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit (ELISA).;Serum NF-kB concentration. Timepoint: At the beginning and at the end of week 12. Method of measurement: Laboratory kit (ELISA).;NF-kB gene expression. Timepoint: At the beginning and at the end of week 12. Method of measurement: Real Time RT-PCR.
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| Sponsor/Collaborators: |
Iran University of Medical Sciences
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| Gender: |
All
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| Age: |
18 yearsno limit
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| Phases: |
Phase 3
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| Enrollment: |
74
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.co
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| Start Date: |
10/04/2017
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
13 July 2020
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/2555
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