| Trial ID: | L0664 |
| Source ID: | IRCT201105026361N1
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| Associated Drug: |
Pioglitazone
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| Title: |
Comparing the treatment effect of Pioglitazone with Metformin in patients with Non Alcoholic SteatoHepatitis (NASH)
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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: |
--
|
| Conditions: |
Fatty liver. <br>fatty (change of) liver, not elsewhere classified;fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention 1: Metformin: Tablet 500 mg, oral, BID, for 4 months. Intervention 2: Pioglitazone: Tablet 30 mg, oral, daily, for 4 months.;Treatment - Drugs;Treatment - Drugs;Metformin: Tablet 500 mg, oral, BID, for 4 months.;Pioglitazone: Tablet 30 mg, or
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| Outcome Measures: |
FBS. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;TG. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Chlo. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;HDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;LDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;AST. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;ALT. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Alkp. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Body weight. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Balance.;HOMA Index. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: fasting Glucose(mmol/L)*Insulin(microunit/ml)/22.5.;Serum Adiponectin. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA).Side effects of drug. Timepoint: before intervention, two months after intervention, end of intervention (four months after intervention). Method of measurement: history, physical examination, plasma sampling.
|
| Sponsor/Collaborators: |
Vice chancellor for research, Kashan University of Medical Sciences and Health Services
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| Gender: |
All
|
| Age: |
21 years50 years
|
| Phases: |
Phase 2
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| Enrollment: |
80
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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| Start Date: |
16/11/2011
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
22 February 2018
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| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/6804
|
