NCT05930093Completed
Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 28 May 2023
- Start date
- 7 Dec 2023
- Primary completion date
- 22 Dec 2025
- Lead sponsor
- TCM Biotech International Corp.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05930093
What you commit to
- Study type: Interventional
- Participants enrolled: 110
- From 7 Dec 2023 to the primary completion date, 22 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.);
Other illness
- 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.
- Known alcohol abuse or alcohol use disorder (\>20 g/day for women; \>30 g/day for men)
- History of HIV
Lab values
- 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
Other
- Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period
Who the study is looking for
- 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
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.