| Trial ID: | L0725 |
| Source ID: | SLCTR/2019/038
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| Associated Drug: |
Delta-tocotrienol
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| Title: |
Comparison of Delta-tocotrienol and Alpha-tocopherol Effects on Biochemical Markers, Micro-RNA Expression and Hepatic Steatosis 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
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| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Study setting: The study will be conducted at Mega Medical Complex Hospital in collaboration with Armed Forces Institute of Pathology and Armed Forces Institute of Radiology (AFIRI) Rawalpindi Pakistan<br><br>Randomization: The patients with NAFLD will
|
| Outcome Measures: |
1.Mean reduction in Fatty Liver Index (FLI) from baseline to week 24 and 48 [Baseline and week 24 and week 48]<br>2. Mean reduction in the measurement of Liver Fat on CT scan (indicated by an increase in the liver-to-spleen (L/S) attenuation ratio) [ Baseline and week 24 and week 48]<br>3. Mean reduction in the measurement of Fibrosis score-4 (FIB-4) [Baseline and week 24 and week 48]<br>1. Mean reduction in the measurement of Alanine tranaminase (IU/L) Aspartate transaminase (IU/L) and Gamma-glutamyl transferase (IU/L)
<br>2. Mean reduction in the measurement of Fasting plasma glucose (mmol/L), Insulin (mIU/L) and Homeostatic Model Assessment for Insulin Resistance (HOMA IR)
<br>3. Mean reduction in the measurement of serum High sensitivity C-reactive protein (mg/L), Interleukin-6 (pg/mL), Tumor necrosis factor
<br>alpha (pg/mL) and Leptin (ng/mL)
<br>4. Mean increase in the measurement of serum Adiponectin (??g/mL)
<br>5. Mean reduction in the measurement of serum Malondialdehyde (??mol/L)
<br>6. Mean reduction in the measurement of serum Cytokeratin18 (CK18-M30) (mIU/ml)
<br>7. Mean reduction in measurement of serum Total cholesterol (mmol/L), Triglycerides (mmol/L) and LDL-cholesterol (mmol/L)
<br>8. Mean reduction in the measurement of Aspartate Aminotransferase to Platelet Count Ratio Index (APRI)
<br>9. Mean reduction in the measurement of NAFLD Fibrosis Score (NFS)
<br>10. Mean fold change in Circulatory miRNAs (miR-122-5p, miR-192-5p, miR-34a-5p, miR-103a, miR-451, miR-21) [Baseline, week 24 and week 48]<br>
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| Sponsor/Collaborators: |
National University of Medical Sciences
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| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
100 (50 per arm)
|
| Study Type: |
Interventional
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| Study Designs: |
Randomized controlled trial
|
| Start Date: |
16/10/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 February 2022
|
| Locations: |
Pakistan
|
| URL: |
https://slctr.lk/trials/slctr-2019-038
|
