| Trial ID: | L0488 |
| Source ID: | IRCT20180824040857N1
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| Associated Drug: |
Propolis
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| Title: |
Effect of Propolis extract on hepatic steatosis and fibrosis status in patients with non-alcoholic fatty liver disease
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non- alcoholic fatty liver disease (NAFLD). <br>Fatty (change of) liver, not elsewhere classified;K76.0
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| Interventions: |
Intervention 1: Intervention group: Propolis extract at a dose of 500 mg per day for four consecutive months. Intervention 2: Control group:Placebo at a dose of 500 mg per day for four consecutive months.
|
| Outcome Measures: |
Hepatic steatosis. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Two-dimensional shear wave elastography (2-D SWE).;Hepatic fibrosis. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Two-dimensional shear wave elastography (2-D SWE).Aspartate aminotransferase (AST). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Total cholesterol. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;LDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;HDL. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;TG. Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Fasting blood sugar (FBS). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).;Alanine aminotransferase (ALT). Timepoint: At the beginning of the study and the fourth month of the intervention. Method of measurement: Colorimetric assay with the use of commercial kits(Pars Azmoon, Tehran, Iran).
|
| Sponsor/Collaborators: |
Mashhad University of Medical Sciences
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| Gender: |
All
|
| Age: |
18 years60 years
|
| Phases: |
Phase 2
|
| Enrollment: |
54
|
| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization, Blinding description: With the exception of a pharmacist, the treatment assignment wil
|
| Start Date: |
24/10/2018
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
6 October 2020
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/33477
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