| Trial ID: | L4291 |
| Source ID: | NCT02289235
|
| Associated Drug: |
Ginger
|
| Title: |
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
|
| Acronym: |
GinLivDM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Fatty Liver|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Ginger|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in ALT (liver transaminases) level, Change in the concentration of ALT (liver transaminases), Baseline and 3 months|Change in score of fatty liver in fibroscan, Change in score of fatty liver in fibroscan (elastography), Baseline and 3 months | Secondary: Change in AST (liver transaminases) level, Change in the concentration of AST (liver transaminases), Baseline and 3 months|Change in Gama GT (γ-glutamyl transpeptidase) levels, Change in the concentration of Gama GT (γ-glutamyl transpeptidase), Baseline and 3 months|Number of patients with adverse events, Number of patients with adverse events, 4 months
|
| Sponsor/Collaborators: |
Sponsor: Shiraz University of Medical Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
76
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-05-01
|
| Completion Date: |
2020-02-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-10-20
|
| Locations: |
Shahid Motahhari Clinic, Shiraz University of Medical Sciences, Shiraz, Fars, Iran, Islamic Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02289235
|
