NAFLDNCT05930093
Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
A study testing 2 cap.LivPhcD/per day, 4 cap.LivPhcD/per day and 6 cap.LivPhcD/per day in people with NAFLD, run by TCM Biotech International Corp. at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- NAFLD
- What is being tested?
- 2 cap.LivPhcD/per day, 4 cap.LivPhcD/per day and 6 cap.LivPhcD/per day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2023to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Not Required For This Country, 221
About this study
Official title: Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to 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.
- Conditions
- NAFLD
- Being tested
- Placebo, 2 cap.LivPhcD/per day, 4 cap.LivPhcD/per day, 6 cap.LivPhcD/per day
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo matching LivPhcD cap.
2 cap.LivPhcD/per dayDietary supplement
2 caps. LivPhcD cap. after meal, once a day
4 cap.LivPhcD/per dayDietary supplement
4 caps. LivPhcD cap. after meal, BID
6 cap.LivPhcD/per dayDietary supplement
6 caps. LivPhcD cap. after meal, TID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo without active ingredient Receives: Dietary Supplement: Placebo |
| 2 cap.LivPhcD/per day | Active comparator | 515mg/LivPhcD cap. 2 cap./per day Receives: Dietary Supplement: 2 cap.LivPhcD/per day |
| 4 cap.LivPhcD/per day | Active comparator | 515mg/LivPhcD cap. 4 cap./per day, BID Receives: Dietary Supplement: 4 cap.LivPhcD/per day |
| 6 cap.LivPhcD/per day | Active comparator | 515mg/LivPhcD cap. 6 cap./per day, TID Receives: Dietary Supplement: 6 cap.LivPhcD/per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 weeks
Secondary outcomes (21)
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
Measured: 24 weeks and 36 weeks
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
Measured: 24 weeks and 36 weeks
Change in liver fat
Between group difference in mean change of liver fat by CAP
Measured: 24 weeks and 36 weeks
Stable in liver fat
Between group difference in the proportion of patients with stable of baseline of liver fat by CAP
Measured: 24 weeks and 36 weeks
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
Measured: 24 weeks and 36 weeks
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
Measured: 24 weeks and 36 weeks
Stable in liver fibrosis
Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan
Measured: 24 weeks and 36 weeks
Change in liver fibrosis
Between group difference in mean change of FIB-4
Measured: 24 weeks and 36 weeks
Change in ALT
Between group difference in mean change or in the proportion of patients of ALT
Measured: 24 weeks and 36 weeks
Change in AST
Between group difference in mean change or in the proportion of patients of AST
Measured: 24 weeks and 36 weeks
Change in GGT
Between group difference in mean change or in the proportion of patients of GGT
Measured: 24 weeks and 36 weeks
Change in AP
Between group difference in mean change or in the proportion of patients of AP
Measured: 24 weeks and 36 weeks
Change in Bilirubin
Between group difference in mean change or in the proportion of patients of Bilirubin
Measured: 24 weeks and 36 weeks
Change in Triglyceride
Between group difference in mean change or in the proportion of patients of Triglyceride
Measured: 24 weeks and 36 weeks
Change in Total Cholesterol
Between group difference in mean change or in the proportion of patients of Total Cholesterol
Measured: 24 weeks and 36 weeks
Change in HDL-C
Between group difference in mean change or in the proportion of patients of HDL-C
Measured: 24 weeks and 36 weeks
Change in LDL-C
Between group difference in mean change or in the proportion of patients of LDL-C
Measured: 24 weeks and 36 weeks
Change in TNF-α
Between group difference in mean change or in the proportion of patients of TNF-α
Measured: 24 weeks and 36 weeks
Change in C-Reactive Protein
Between group difference in mean change or in the proportion of patients of C-Reactive Protein
Measured: 24 weeks and 36 weeks
Change in Albumin
Between group difference in mean change or in the proportion of patients of Albumin
Measured: 24 weeks and 36 weeks
Occurrence of adverse events and serious adverse events
Between group difference in the occurrence of adverse events and serious adverse events.
Measured: 24 weeks and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start7 Dec 2023
- Primary completion22 Dec 2025
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCM Biotech International Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930093
- Sponsor's protocol ID
- LivPhcD-001
- Status last verified
- Sep 2026
- First submitted
- 28 May 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
- ClinicalTrials.gov ID
- NCT05930093
- Acronym / sponsor ID
- LivPhcD-001
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- TCM Biotech International Corp.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo without active ingredient |
| 2 cap.LivPhcD/per day | Active comparator | Dietary Supplement: 2 cap.LivPhcD/per day515mg/LivPhcD cap. 2 cap./per day |
| 4 cap.LivPhcD/per day | Active comparator | Dietary Supplement: 4 cap.LivPhcD/per day515mg/LivPhcD cap. 4 cap./per day, BID |
| 6 cap.LivPhcD/per day | Active comparator | Dietary Supplement: 6 cap.LivPhcD/per day515mg/LivPhcD cap. 6 cap./per day, TID |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo matching LivPhcD cap. | Dietary supplement | Placebo |
| 2 cap.LivPhcD/per day2 caps. LivPhcD cap. after meal, once a day | Dietary supplement | 2 cap.LivPhcD/per day |
| 4 cap.LivPhcD/per day4 caps. LivPhcD cap. after meal, BID | Dietary supplement | 4 cap.LivPhcD/per day |
| 6 cap.LivPhcD/per day6 caps. LivPhcD cap. after meal, TID | Dietary supplement | 6 cap.LivPhcD/per day |
Primary outcome
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)
21 secondary outcomes
Change in liver fat at least 30% reduction
Time frame: 24 weeks and 36 weeks
Change in liver fat at least 1 stage reduction
Time frame: 24 weeks and 36 weeks
Change in liver fat
Time frame: 24 weeks and 36 weeks
Stable in liver fat
Time frame: 24 weeks and 36 weeks
Change in liver fibrosis at least 10% reduction
Time frame: 24 weeks and 36 weeks
Change in liver fibrosis at least 1 stage reduction
Time frame: 24 weeks and 36 weeks
Stable in liver fibrosis
Time frame: 24 weeks and 36 weeks
Change in liver fibrosis
Time frame: 24 weeks and 36 weeks
Change in ALT
Time frame: 24 weeks and 36 weeks
Change in AST
Time frame: 24 weeks and 36 weeks
Change in GGT
Time frame: 24 weeks and 36 weeks
Change in AP
Time frame: 24 weeks and 36 weeks
Change in Bilirubin
Time frame: 24 weeks and 36 weeks
Change in Triglyceride
Time frame: 24 weeks and 36 weeks
Change in Total Cholesterol
Time frame: 24 weeks and 36 weeks
Change in HDL-C
Time frame: 24 weeks and 36 weeks
Change in LDL-C
Time frame: 24 weeks and 36 weeks
Change in TNF-α
Time frame: 24 weeks and 36 weeks
Change in C-Reactive Protein
Time frame: 24 weeks and 36 weeks
Change in Albumin
Time frame: 24 weeks and 36 weeks
Occurrence of adverse events and serious adverse events
Time frame: 24 weeks and 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 cap.LivPhcD/per day, 4 cap.LivPhcD/per day and 6 cap.LivPhcD/per day in people with NAFLD, run by TCM Biotech International Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Liver Fat (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.