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Non-alcoholic fatty liver disease (also called NAFLD) is a disease in which excessive fat accumulates in the liver of a patient without a history of alcohol abuse. Early-stage NAFLD does not usually cause any harm but nonalcoholic steatohepatitis (NASH) can lead to serious liver damage, including fibrosis or cirrhosis. Nearly 25% of the world's population is affected by NAFLD.
There are no FDA-approved medications for the treatment of NAFLD currently and although lifestyle modifications with appropriate diet and exercise have been shown to be beneficial, this has been difficult to achieve and sustain for the majority of patients.
LivPhcD™ capsule have shown hepatoprotective effects in both animal and human data. This study aims to investigate the effects of LivPhcD™ capsule in hepatocellular lipid content using Fibroscan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo without active ingredient |
|
| 2 cap.LivPhcD/per day | Active Comparator | 515mg/LivPhcD cap. 2 cap./per day |
|
| 4 cap.LivPhcD/per day | Active Comparator | 515mg/LivPhcD cap. 4 cap./per day, BID |
|
| 6 cap.LivPhcD/per day | Active Comparator | 515mg/LivPhcD cap. 6 cap./per day, TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo matching LivPhcD cap. |
| |
| 2 cap.LivPhcD/per day |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Liver Fat | Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter) | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver fat at least 30% reduction | Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP | 24 weeks and 36 weeks |
| Change in liver fat at least 1 stage reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Jen Liu, Ph.D | Contact | +886-2-23123456 | 67503 | cjliu@ntu.edu.tw |
| Wen-Chuan Huang, Master | Contact | +886-2-26972628 | 600 | lillian@tcmbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Not Required For This Country | 221 | Taiwan |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Dietary Supplement |
2 caps. LivPhcD cap. after meal, once a day |
|
| 4 cap.LivPhcD/per day | Dietary Supplement | 4 caps. LivPhcD cap. after meal, BID |
|
| 6 cap.LivPhcD/per day | Dietary Supplement | 6 caps. LivPhcD cap. after meal, TID |
|
Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP
| 24 weeks and 36 weeks |
| Change in liver fat | Between group difference in mean change of liver fat by CAP | 24 weeks and 36 weeks |
| Stable in liver fat | Between group difference in the proportion of patients with stable of baseline of liver fat by CAP | 24 weeks and 36 weeks |
| Change in liver fibrosis at least 10% reduction | Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan | 24 weeks and 36 weeks |
| Change in liver fibrosis at least 1 stage reduction | Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan | 24 weeks and 36 weeks |
| Stable in liver fibrosis | Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan | 24 weeks and 36 weeks |
| Change in liver fibrosis | Between group difference in mean change of FIB-4 | 24 weeks and 36 weeks |
| Change in ALT | Between group difference in mean change or in the proportion of patients of ALT | 24 weeks and 36 weeks |
| Change in AST | Between group difference in mean change or in the proportion of patients of AST | 24 weeks and 36 weeks |
| Change in GGT | Between group difference in mean change or in the proportion of patients of GGT | 24 weeks and 36 weeks |
| Change in AP | Between group difference in mean change or in the proportion of patients of AP | 24 weeks and 36 weeks |
| Change in Bilirubin | Between group difference in mean change or in the proportion of patients of Bilirubin | 24 weeks and 36 weeks |
| Change in Triglyceride | Between group difference in mean change or in the proportion of patients of Triglyceride | 24 weeks and 36 weeks |
| Change in Total Cholesterol | Between group difference in mean change or in the proportion of patients of Total Cholesterol | 24 weeks and 36 weeks |
| Change in HDL-C | Between group difference in mean change or in the proportion of patients of HDL-C | 24 weeks and 36 weeks |
| Change in LDL-C | Between group difference in mean change or in the proportion of patients of LDL-C | 24 weeks and 36 weeks |
| Change in TNF-α | Between group difference in mean change or in the proportion of patients of TNF-α | 24 weeks and 36 weeks |
| Change in C-Reactive Protein | Between group difference in mean change or in the proportion of patients of C-Reactive Protein | 24 weeks and 36 weeks |
| Change in Albumin | Between group difference in mean change or in the proportion of patients of Albumin | 24 weeks and 36 weeks |
| Occurrence of adverse events and serious adverse events | Between group difference in the occurrence of adverse events and serious adverse events. | 24 weeks and 36 weeks |