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

NCT05930093 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-04-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TCM Biotech International Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2026-01-31
Completion
2026-05-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930093 on ClinicalTrials.gov