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NCT Number: NCT05930093

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

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.

Recruiting

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Not Required For This Country, 221, Taiwan

Location status: Recruiting

Location contact

Chun-Jen Liu, Ph. D

CONTACT

[email protected]

+886-2-2312-3456

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period
  • Type 1 diabetes mellitus.
  • 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.
  • 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.
  • 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.
  • 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
  • Known alcohol abuse or alcohol use disorder (>20 g/day for women; >30 g/day for men)
  • 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
  • Subjects with hemoglobin A1c (HbA1c) >8.5% within 3 months before study entry
  • Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery)
  • 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.);
  • History of HIV

Treatment and study plan

Placebo

Dietary Supplement

Placebo matching LivPhcD cap.

2 cap.LivPhcD/per day

Dietary Supplement

2 caps. LivPhcD cap. after meal, once a day

4 cap.LivPhcD/per day

Dietary Supplement

4 caps. LivPhcD cap. after meal, BID

6 cap.LivPhcD/per day

Dietary Supplement

6 caps. LivPhcD cap. after meal, TID

Primary outcomes

  1. Reduction of Liver Fat

    Time frame: 36 weeks

    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)

Secondary outcomes

  1. Change in liver fat at least 30% reduction

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP

  2. Change in liver fat at least 1 stage reduction

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP

  3. Change in liver fat

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change of liver fat by CAP

  4. Stable in liver fat

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with stable of baseline of liver fat by CAP

  5. Change in liver fibrosis at least 10% reduction

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan

  6. Change in liver fibrosis at least 1 stage reduction

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan

  7. Stable in liver fibrosis

    Time frame: 24 weeks and 36 weeks

    Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan

  8. Change in liver fibrosis

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change of FIB-4

  9. Change in ALT

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of ALT

  10. Change in AST

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of AST

  11. Change in GGT

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of GGT

  12. Change in AP

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of AP

  13. Change in Bilirubin

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of Bilirubin

  14. Change in Triglyceride

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of Triglyceride

  15. Change in Total Cholesterol

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of Total Cholesterol

  16. Change in HDL-C

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of HDL-C

  17. Change in LDL-C

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of LDL-C

  18. Change in TNF-α

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of TNF-α

  19. Change in C-Reactive Protein

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of C-Reactive Protein

  20. Change in Albumin

    Time frame: 24 weeks and 36 weeks

    Between group difference in mean change or in the proportion of patients of Albumin

  21. Occurrence of adverse events and serious adverse events

    Time frame: 24 weeks and 36 weeks

    Between group difference in the occurrence of adverse events and serious adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Jen Liu, Ph.D

CONTACT

[email protected]

+886-2-23123456 ext. 67503

Wen-Chuan Huang, Master

CONTACT

[email protected]

+886-2-26972628 ext. 600

Sponsors and collaborators

Lead sponsor

TCM Biotech International Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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