National Taiwan University Hospital
Taipei, Not Required For This Country, 221, Taiwan
Location status: Recruiting
NCT Number: NCT05930093
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.
Interested in participating?
Request Info20 year–75 year
All sexes
Interventional
Not applicable
Taipei, Not Required For This Country, 221, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo matching LivPhcD cap.
2 caps. LivPhcD cap. after meal, once a day
4 caps. LivPhcD cap. after meal, BID
6 caps. LivPhcD cap. after meal, TID
Time frame: 36 weeks
Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP
Time frame: 24 weeks and 36 weeks
Between group difference in mean change of liver fat by CAP
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with stable of baseline of liver fat by CAP
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan
Time frame: 24 weeks and 36 weeks
Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan
Time frame: 24 weeks and 36 weeks
Between group difference in mean change of FIB-4
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of ALT
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of AST
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of GGT
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of AP
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of Bilirubin
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of Triglyceride
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of Total Cholesterol
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of HDL-C
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of LDL-C
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of TNF-α
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of C-Reactive Protein
Time frame: 24 weeks and 36 weeks
Between group difference in mean change or in the proportion of patients of Albumin
Time frame: 24 weeks and 36 weeks
Between group difference in the occurrence of adverse events and serious adverse events.
Contact information is provided by the study sponsor or research team.
Chun-Jen Liu, Ph.D
CONTACT
+886-2-23123456 ext. 67503
Wen-Chuan Huang, Master
CONTACT
+886-2-26972628 ext. 600
TCM Biotech International Corp.
Industry
Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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