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

Not Applicable

Recruiting

• Conditions: NAFLD
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: 2 cap.LivPhcD/per day; Dietary Supplement: 4 cap.LivPhcD/per day; Dietary Supplement: 6 cap.LivPhcD/per day

• Registration Number: NCT05930093
• Lead Sponsor: TCM Biotech International Corp.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-07-05
• Study Start: 2023-12-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Male or female between 20 and 75 years of age.
2. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
3. Has a body mass index (BMI) ≥20 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months
4. CAP ≥ 238 db/m
5. Fibro scan (transient elastography) F0~F3

Exclusion Criteria

1. Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period
2. Type 1 diabetes mellitus.
3. History of other causes of chronic liver disease [autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc.
4. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine.
5. Use of vitamin E (doses ≥800 IU/dy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study.
6. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation
7. Known alcohol abuse or alcohol use disorder (>20 g/day for women; >30 g/day for men)
8. Has the abnormal data including: fasting TG >400 mg/dL ; ALT or GGT>5.0 x ULN；Bilirubin >2 x ULN，unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin < LLN; Platelet <0.95x LLN
9. Subjects with hemoglobin A1c (HbA1c) >8.5% within 3 months before study entry
10. Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery)
11. Participation in any other investigational clinical trial within 30 days of entry to this protocol(including drugs, medical devices, novel medical technologies, food, and lifestyle interventions affecting diet, exercise, and circadian rhythm investigational clinical trial.);
12. History of HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo without active ingredient
2 cap.LivPhcD/per day	2 cap.LivPhcD/per day	515mg/LivPhcD cap. 2 cap./per day
4 cap.LivPhcD/per day	4 cap.LivPhcD/per day	515mg/LivPhcD cap. 4 cap./per day, BID
6 cap.LivPhcD/per day	6 cap.LivPhcD/per day	515mg/LivPhcD cap. 6 cap./per day, TID

Primary Outcome Measures

Name	Time	Method
Reduction of Liver Fat	36 weeks	Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)

Secondary Outcome Measures

Name	Time	Method
Change in GGT	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of GGT
Change in LDL-C	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of LDL-C
Change in TNF-α	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of TNF-α
Change in liver fat	24 weeks and 36 weeks	Between group difference in mean change of liver fat by CAP
Change in liver fibrosis at least 10% reduction	24 weeks and 36 weeks	Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan
Stable in liver fibrosis	24 weeks and 36 weeks	Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan
Change in ALT	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of ALT
Change in AP	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of AP
Change in Total Cholesterol	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of Total Cholesterol
Change in liver fat at least 30% reduction	24 weeks and 36 weeks	Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP
Change in liver fat at least 1 stage reduction	24 weeks and 36 weeks	Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP
Stable in liver fat	24 weeks and 36 weeks	Between group difference in the proportion of patients with stable of baseline of liver fat by CAP
Change in liver fibrosis at least 1 stage reduction	24 weeks and 36 weeks	Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan
Change in Triglyceride	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of Triglyceride
Change in liver fibrosis	24 weeks and 36 weeks	Between group difference in mean change of FIB-4
Change in AST	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of AST
Change in Bilirubin	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of Bilirubin
Change in HDL-C	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of HDL-C
Change in Albumin	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of Albumin
Occurrence of adverse events and serious adverse events	24 weeks and 36 weeks	Between group difference in the occurrence of adverse events and serious adverse events.
Change in C-Reactive Protein	24 weeks and 36 weeks	Between group difference in mean change or in the proportion of patients of C-Reactive Protein

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Not required for this country, Taiwan