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Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Sponsor: TCM Biotech International Corp.
Summary
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.
Official title: Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Key Details
Gender
All
Age Range
20 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2023-12-07
Completion Date
2026-05-01
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo matching LivPhcD cap.
2 cap.LivPhcD/per day
2 caps. LivPhcD cap. after meal, once a day
4 cap.LivPhcD/per day
4 caps. LivPhcD cap. after meal, BID
6 cap.LivPhcD/per day
6 caps. LivPhcD cap. after meal, TID
Locations (1)
National Taiwan University Hospital
Taipei, Not Required For This Country, Taiwan