Health TrialsbyHealthPanel

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

ConditionNAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorTCM Biotech International Corp.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m² and ≤50 kg/m² and stable weight for the past 3 months

CAP ≥ 238 db/m

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: 2 cap.LivPhcD/per dayActive comparator 1 intervention
Group C: 4 cap.LivPhcD/per dayActive comparator 1 intervention
Group D: 6 cap.LivPhcD/per dayActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TCM Biotech International Corp.

Lead sponsor

Source ClinicalTrials.gov
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