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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female between 20 and 75 years of age.

• Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.

• Has a body mass index (BMI) ≥20 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months

• CAP ≥ 238 db/m

• Fibro scan (transient elastography) F0\

⁃ F3

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Chun-Jen Liu, Ph.D
cjliu@ntu.edu.tw
+886-2-23123456
Backup
Wen-Chuan Huang, Master
lillian@tcmbio.com
+886-2-26972628
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 108
Treatments
Placebo_comparator: Placebo
Placebo without active ingredient
Active_comparator: 2 cap.LivPhcD/per day
515mg/LivPhcD cap. 2 cap./per day
Active_comparator: 4 cap.LivPhcD/per day
515mg/LivPhcD cap. 4 cap./per day, BID
Active_comparator: 6 cap.LivPhcD/per day
515mg/LivPhcD cap. 6 cap./per day, TID
Related Therapeutic Areas
Sponsors
Leads: TCM Biotech International Corp.

This content was sourced from clinicaltrials.gov