| Trial ID: | L0647 |
| Source ID: | IRCT201012084010N4
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| Associated Drug: |
Synbiotics
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| Title: |
The effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
|
| Acronym: |
--
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| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic steatohepatitis (NASH). <br>Nonalcoholic steatohepatitis (NASH);Nonalcoholic steatohepatitis (NASH)
|
| Interventions: |
Intervention 1: intervention: 2 protexin capsules for 7 months. Intervention 2: control: 2 placebo capsule (Maltodexterin) for 7 months.;Treatment - Drugs;Placebo;intervention: 2 protexin capsules for 7 months;control: 2 placebo capsule (Maltodexterin) fo
|
| Outcome Measures: |
ALT, AST, GGT. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Hs-CRP, TNF-a. Timepoint: at the beginning and at the last. Method of measurement: ELISA & Nephlometer.;Liver fibrosis. Timepoint: at the beginning and at the last. Method of measurement: Fibroscan.;FBS. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Cholestrol, TG, LDL-c, HDL-c. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.Weight and BMI. Timepoint: at weeks: 0, 14, 28. Method of measurement: Weight will be measured by Secca scale , BMI by formula.;Waist circumference, hip circumfereance. Timepoint: at weeks: 0, 14, 28. Method of measurement: non stretch meter.;Insulin. Timepoint: at weeks: 0, 14, 28. Method of measurement: ELISA.;Insulin resistance. Timepoint: at weeks: 0, 28. Method of measurement: formula.
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| Sponsor/Collaborators: |
National Nutrition and Food Technology Research Institute (NNFTRI)
|
| Gender: |
All
|
| Age: |
18 years70 years
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
50
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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| Start Date: |
30/11/2012
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
22 February 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/4186
|
