Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
NCT ID: NCT05930093
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2023-12-07
2026-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo without active ingredient
Placebo
Placebo matching LivPhcD cap.
2 cap.LivPhcD/per day
515mg/LivPhcD cap. 2 cap./per day
2 cap.LivPhcD/per day
2 caps. LivPhcD cap. after meal, once a day
4 cap.LivPhcD/per day
515mg/LivPhcD cap. 4 cap./per day, BID
4 cap.LivPhcD/per day
4 caps. LivPhcD cap. after meal, BID
6 cap.LivPhcD/per day
515mg/LivPhcD cap. 6 cap./per day, TID
6 cap.LivPhcD/per day
6 caps. LivPhcD cap. after meal, TID
Interventions
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Placebo
Placebo matching LivPhcD cap.
2 cap.LivPhcD/per day
2 caps. LivPhcD cap. after meal, once a day
4 cap.LivPhcD/per day
4 caps. LivPhcD cap. after meal, BID
6 cap.LivPhcD/per day
6 caps. LivPhcD cap. after meal, TID
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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TCM Biotech International Corp.
INDUSTRY
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, Not Required For This Country, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LivPhcD-001
Identifier Type: -
Identifier Source: org_study_id
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