AzTrials
AzTrials

Fatty Liver DiseaseNCT05076058

Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver

A study testing Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza in people with Fatty Liver Disease, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver. Design: a double-blinded randomized placebo-controlled clinical trial. Setting: community residents, Guangzhou city, South China. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fatty Liver Disease
What is being tested?
Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteChina
Study dates
1 Mar 2021to 30 Jun 2022
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-65 years
  • BMI: 24-30 kg/m2
  • Fatty liver, assessed by ultrasound or MR
  • Had normal diet and normal daily life.

Who cannot join

  • Hospital confirmed diseases of heart, liver (viral hepatitis, drug-induced liver injury, cirrhosis), kidney, brain, hematopoietic system，diabetes, immune system, and cancer；
  • Taking medicine or supplements known to affect fatty liver, body fat;
  • Body weight had changed more than 10% within the past 3 months;
  • Physical or mental disabled to participate the trial;
  • Compliance of tablet consumption is/was less than 80% in run-in period;
  • Pregnant or lactating women, or intended pregnancy during the trial period;
Show all 9Show fewer
  • Be allergic to the proposed supplements；
  • Attended or plan to attend other trial(s);
  • Be unwell to sign the informed consent form, or have other conditions that be not suitable to attend the trial considered by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on the Progression of Fatty Liver in Adults: a Double-blinded Randomized Placebo-controlled Clinical Trial

Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver.

Design: a double-blinded randomized placebo-controlled clinical trial.

Read more

Setting: community residents, Guangzhou city, South China.

Participants: a total 118 men and women (18-65 years), with BMI range of 24-30 kg/m2, and with fatty liver screened by ultrasound or MR at baseline.

Arms and Interventions: 118 participants were randomly allocated into two arms using a block randomization method. Experimental Arm: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, 3 tablets (1g each) twice a day for 6 months; Placebo Arm: placebo tablets, 3 tablets (1g each) twice a day for 6 months.

Outcome Measures: determined at baseline and at 6 months post treatment

  1. Primary Outcome Measures: 1) proton density fat fraction of liver assessed by MR; 2) serum liver fibrosis biomarkers: type procollagen III N terminal peptide, hyaluronic acid, laminin, collagen type IV, and glycocholic acid; 3) NAFLD fibrosis score.
  2. Secondary Outcome Measures: 1) serum liver function biomarkers: AST, ALT, GGT, ALP, total protein, and bile acids; 2) fasting blood lipids: total triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol; 3) fasting serum glucose and insulin; 4) serum inflammatory factors (hsCRP and IL-6); 5) oxidative stress: SOD and MDA; and 6) body measurements and body fat mass.

Data Analyses: Mean changes in the above outcome measures from baseline to 6 months will be compared between the two arms.

Being tested
Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, Placebo tablet
Keywords
fatty liver, silybum marianum, Pueraria lobate, salvia miltiorrhiza
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhizaDietary supplement

    Brand names: BY-HEALTH；

    Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g

  • Placebo tabletOther

    Brand names: BY-HEALTH；

    Main contents : starch

Study groups in NCT05076058
Study groupRoleWhat they receive
Treatment groupExperimentalTablet name: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months
Receives: Dietary Supplement: Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza
Control groupPlacebo comparatorTablet name: Placebo; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months
Receives: Other: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline proton density fat fraction of liver at 6 months

    Proton density fat fraction of liver: measured using magnetic resonance (MR)

    Measured: 0 and 6 months

  2. Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months

    Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide

    Measured: 0 and 6 months

  3. Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months

    Liver fibrosis biomarker 2: hyaluronic acid

    Measured: 0 and 6 months

  4. Change from baseline liver fibrosis biomarker (laminin) at 6 months

    Liver fibrosis biomarker 3: laminin

    Measured: 0 and 6 months

  5. Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months

    Liver fibrosis biomarker 4: Collagen type IV

    Measured: 0 and 6 months

  6. Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months

    Liver fibrosis biomarker 5: Glycocholic acid

    Measured: 0 and 6 months

  7. Change from baseline NAFLD fibrosis score at 6 months

    NAFLD fibrosis score: = -1.675 + 0.037 Age (yrs) + 0.094 BMI (kg/m2) + 1.13 impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 AST/ALT ratio - 0.013Platelet (*10E9/L) - 0.66 Albumin (g/dl)

    Measured: 0 and 6 months

Secondary outcomes (20)

  1. Change from baseline liver function biomarker (AST) at 6 months

    Liver function biomarkers 1: AST

    Measured: 0 and 6 months

  2. Change from baseline liver function biomarker (ALT) at 6 months

    Liver function biomarkers 2: serum ALT

    Measured: 0 and 6 months

  3. Change from baseline liver function biomarker (GGT) at 6 months

    Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)

    Measured: 0 and 6 months

  4. Change from baseline liver function biomarker (total protein) at 6 months

    Liver function biomarkers 4: serum total protein

    Measured: 0 and 6 months

  5. Change from baseline liver function biomarker (ALP) at 6 months

    Liver function biomarkers 5: serum alkaline phosphatase (ALP)

    Measured: 0 and 6 months

  6. Change from baseline liver function biomarker (bile acids) at 6 months

    Liver function biomarkers 6: serum bile acids

    Measured: 0 and 6 months

  7. Change from baseline fasting blood lipid (TG) at 6 months

    Fasting blood lipid 1: serum triglycerides

    Measured: 0 and 6 months

  8. Change from baseline fasting blood lipid (TC) at 6 months

    Fasting blood lipid 2: serum total cholesterol

    Measured: 0 and 6 months

  9. Change from baseline fasting blood lipid (HDL-C) at 6 months

    Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C)

    Measured: 0 and 6 months

  10. Change from baseline fasting blood lipid (LDL-C) at 6 months

    Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)

    Measured: 0 and 6 months

  11. Change from baseline fasting blood glucose at 6 months

    Fasting blood glucose: serum glucose

    Measured: 0 and 6 months

  12. Change from baseline fasting blood insulin at 6 months

    Fasting blood insulin: serum insulin

    Measured: 0 and 6 months

  13. Change from baseline systolic blood pressure at 6 months

    Blood pressure: systolic blood pressure

    Measured: 0 and 6 months

  14. Change from baseline diastolic blood pressure at 6 months

    Blood pressure: diastolic blood pressure

    Measured: 0 and 6 months

  15. Change from baseline Inflammatory factor (hsCRP ) at 6 months

    Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)

    Measured: 0 and 6 months

  16. Change from baseline Inflammatory factor (IL-6) at 6 months

    Inflammatory factor 2: serum IL-6

    Measured: 0 and 6 months

  17. Change from baseline oxidative stress (SOD) at 6 months

    Oxidative stress biomarker 1: serum SOD

    Measured: 0 and 6 months

  18. Change from baseline oxidative stress (MDA) at 6 months

    Oxidative stress biomarker 2: serum malondialdehyde (MDA)

    Measured: 0 and 6 months

  19. Change from baseline fat mass at 6 months

    Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)

    Measured: 0 and 6 months

  20. Change from baseline percentage fat mass at 6 months

    Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA

    Measured: 0 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start1 Mar 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

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
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076058
Sponsor's protocol ID
K19-51000-043
Status last verified
Sep 2021
First submitted
10 Sep 2021
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li BY, Xi Y, Liu YP, Wang D, Wang C, Chen CG, Fang XH, Li ZX, Chen YM. Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial. Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.

    PubMed 38879879

Questions about this trial

What is this clinical trial studying?

A study testing Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza in people with Fatty Liver Disease, run by Sun Yat-sen University at 1 site in China.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 China. 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?

Results are not available in the source record.

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?

Change from baseline proton density fat fraction of liver at 6 months (time frame: 0 and 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076058, which also lists 1 linked publication.

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 13 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in