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CompletedNCT05930093Updated Oct 2, 2026

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

An interventional study of Placebo and 2 cap.LivPhcD/per day in NAFLD, sponsored by TCM Biotech International Corp.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by TCM Biotech International Corp. · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • NAFLD
03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 110 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

TCM Biotech International Corp. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo without active ingredient

    Dietary Supplement: Placebo

  • Active comparator
    2 cap.LivPhcD/per day

    515mg/LivPhcD cap. 2 cap./per day

    Dietary Supplement: 2 cap.LivPhcD/per day

  • Active comparator
    4 cap.LivPhcD/per day

    515mg/LivPhcD cap. 4 cap./per day, BID

    Dietary Supplement: 4 cap.LivPhcD/per day

  • Active comparator
    6 cap.LivPhcD/per day

    515mg/LivPhcD cap. 6 cap./per day, TID

    Dietary Supplement: 6 cap.LivPhcD/per day

Interventions

  • Dietary supplementPlacebo

    Placebo matching LivPhcD cap.

  • Dietary supplement2 cap.LivPhcD/per day

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

  • Dietary supplement4 cap.LivPhcD/per day

    4 caps. LivPhcD cap. after meal, BID

  • Dietary supplement6 cap.LivPhcD/per day

    6 caps. LivPhcD cap. after meal, TID

06

What researchers measure

Primary outcomes

  1. Reduction of Liver Fat

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

    Time frame: 36 weeks

Secondary outcomes

  1. Change in liver fat at least 30% reduction

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

    Time frame: 24 weeks and 36 weeks

  2. Change in liver fat at least 1 stage reduction

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

    Time frame: 24 weeks and 36 weeks

  3. Change in liver fat

    Between group difference in mean change of liver fat by CAP

    Time frame: 24 weeks and 36 weeks

  4. Stable in liver fat

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

    Time frame: 24 weeks and 36 weeks

  5. Change in liver fibrosis at least 10% reduction

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

    Time frame: 24 weeks and 36 weeks

  6. Change in liver fibrosis at least 1 stage reduction

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

    Time frame: 24 weeks and 36 weeks

  7. Stable in liver fibrosis

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

    Time frame: 24 weeks and 36 weeks

  8. Change in liver fibrosis

    Between group difference in mean change of FIB-4

    Time frame: 24 weeks and 36 weeks

  9. Change in ALT

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

    Time frame: 24 weeks and 36 weeks

  10. Change in AST

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

    Time frame: 24 weeks and 36 weeks

  11. Change in GGT

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

    Time frame: 24 weeks and 36 weeks

  12. Change in AP

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

    Time frame: 24 weeks and 36 weeks

  13. Change in Bilirubin

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

    Time frame: 24 weeks and 36 weeks

  14. Change in Triglyceride

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

    Time frame: 24 weeks and 36 weeks

  15. Change in Total Cholesterol

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

    Time frame: 24 weeks and 36 weeks

  16. Change in HDL-C

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

    Time frame: 24 weeks and 36 weeks

  17. Change in LDL-C

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

    Time frame: 24 weeks and 36 weeks

  18. Change in TNF-α

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

    Time frame: 24 weeks and 36 weeks

  19. Change in C-Reactive Protein

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

    Time frame: 24 weeks and 36 weeks

  20. Change in Albumin

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

    Time frame: 24 weeks and 36 weeks

  21. Occurrence of adverse events and serious adverse events

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

    Time frame: 24 weeks and 36 weeks

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Not Required For This Country 221, Taiwan
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 2, 2026
Sites
1 site added, 1 site removed
Show site
  • National Taiwan University Hospital · Taipei, Taiwan
Show 1 removed
  • National Taiwan University Hospital · Taipei City, Taiwan
Oct 2, 2026
Primary completion
Jan 2026→Dec 22, 2025 (actual)
Oct 2, 2026
Study completion
May 1, 2026→Jan 22, 2026 (actual)
Oct 2, 2026
Enrollment
108 (estimated)→110 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • National Taiwan University Hospital · Taipei, Taiwan
    Show 1 removed
    • National Taiwan University Hospital · Taipei City, Taiwan
    Primary completion Jan 2026→Dec 22, 2025 (now actual)
    Study completion May 1, 2026→Jan 22, 2026 (now actual)
    Enrollment 108 (estimated)→110 (actual)
    + 4 other changes: index terms, verification date, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05930093
Lead sponsor
TCM Biotech International Corp.
Responsible party
Sponsor
First posted
Jul 5, 2023
Start date
Dec 7, 2023
Primary completion
Dec 22, 2025
Completion
Jan 22, 2026
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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