Actively Recruiting
Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Led by TCM Biotech International Corp. · Updated on 2025-04-10
108
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 20 and 75 years of age
- Able to give written informed consent and communicate with study staff
- Body mass index (BMI) between 20 and 50 kg/m² with stable weight for 3 months
- Controlled attenuation parameter (CAP) of 238 dB/m or higher
- Fibroscan liver stiffness score between F0 and F3
You will not qualify if you...
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception during study
- Type 1 diabetes mellitus
- History of other chronic liver diseases such as autoimmune, primary biliary cirrhosis, hepatitis B or C, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis
- Use of medications that can cause liver fat accumulation, including certain hormones, amiodarone, methotrexate, tamoxifen, raloxifene, high-dose glucocorticoids, or chloroquine
- Use of vitamin E above 800 IU/day, pioglitazone, SGLT2 inhibitors, GLP-1 agonists, or any FDA-approved drugs for NASH
- Serious systemic illnesses like recent congestive heart failure, unstable coronary artery disease, serious COPD, renal failure requiring dialysis, stroke, transient ischemic attack, or organ transplant
- Known alcohol abuse or use disorder (above 20 g/day for women; above 30 g/day for men)
- Abnormal lab results including very high triglycerides, liver enzymes, bilirubin, INR, low albumin or platelets
- Hemoglobin A1c above 8.5% within 3 months before study entry
- Planned major surgery during the study period
- Participation in another investigational clinical trial within 30 days before enrollment
- History of HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Not Required For This Country, Taiwan, 221
Actively Recruiting
Research Team
C
Chun-Jen Liu, Ph.D
CONTACT
W
Wen-Chuan Huang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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