Study completion date changed from estimate of May 1, 2026 to Jan 22, 2026
Enrollment target: estimated 108 to confirmed 110
Primary completion date changed from estimate of Jan 2026 to Dec 22, 2025
Interventions: 2 cap.LivPhcD/per day (Dietary Supplement), 4 cap.LivPhcD/per day (Dietary Supplement), 6 cap.LivPhcD/per day (Dietary Supplement), Placebo… to 2 cap.LivPhcD/per day (Dietary Supplement), 4 cap.LivPhcD/per day (Dietary Supplement), 6 cap.LivPhcD/per day (Dietary Supplement), Placebo…
Eligibility criteria expanded, about 6 words
Site details revised
NotablePrimary completion date: Mar 1, 2025 to Jan 2026
Study completion date: May 1, 2025 to May 1, 2026
v5
MinorEligibility criteria expanded, about 19 wordsv4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 1
Start date changed from estimate of Dec 2, 2023 to Dec 7, 2023
v3
NotableStart date: Oct 2, 2023 to Dec 2, 2023v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.