NCT05930093

Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: TCM Biotech International Corp. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NAFLD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo matching LivPhcD cap.
DIETARY_SUPPLEMENT	2 cap.LivPhcD/per day	2 caps. LivPhcD cap. after meal, once a day
DIETARY_SUPPLEMENT	4 cap.LivPhcD/per day	4 caps. LivPhcD cap. after meal, BID
DIETARY_SUPPLEMENT	6 cap.LivPhcD/per day	6 caps. LivPhcD cap. after meal, TID

Timeline

• Start date: 2023-12-07
• Primary completion: 2026-01-01
• Completion: 2026-05-01
• First posted: 2023-07-05
• Last updated: 2025-04-10

Locations

1 site across 1 country: Taiwan