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RECRUITING
NCT05930093
NA

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

Sponsor: TCM Biotech International Corp.

View on ClinicalTrials.gov

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

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

Locations (1)

National Taiwan University Hospital

Taipei, Not Required For This Country, Taiwan