Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05076058
Other study ID # K19-51000-043
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2022

Study information

Verified date September 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 118
Est. completion date June 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age: 18-65 years - BMI: 24-30 kg/m2 - Fatty liver, assessed by ultrasound or MR - Had normal diet and normal daily life. Exclusion Criteria: - 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; - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza
Brand names: BY-HEALTH; Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g,Puerarin 0.68g
Other:
Placebo tablet
Brand names: BY-HEALTH; Main contents : starch

Locations

Country Name City State
China Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline body weight at 6 months Body measurement 1: Body weight (in kg) 0 and 6 months
Other Change from baseline body height at 6 months Body measurement 2: Body height (in cm) 0 and 6 months
Other Change from baseline waist circumference at 6 months Body measurement 3: Waist circumference (in cm) 0 and 6 months
Other Change from baseline hip circumference at 6 months Body measurement 4: hip circumference (in cm) 0 and 6 months
Other Change from baseline anxiety score at 6 months Anxiety Score: assessed by a Self Rating Anxiety Scale (SAS).the minimum and maximum values: 25-100 points. Higher scores mean worse outcome. 0 and 6 months
Other Number of treated events related to supplements between baseline to 6 months Adverse/side effects: Assessed by using questionnaire of medical history, medication use, symptoms. 0 and 6 months
Other Percentage of the interventional supplements consumed between baseline to 6 months Compliance assessment: Assessed by counting the number of remaining supplemental tablets at 6 months at 6 months
Primary Change from baseline proton density fat fraction of liver at 6 months Proton density fat fraction of liver: measured using magnetic resonance (MR) 0 and 6 months
Primary 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 0 and 6 months
Primary Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months Liver fibrosis biomarker 2: hyaluronic acid 0 and 6 months
Primary Change from baseline liver fibrosis biomarker (laminin) at 6 months Liver fibrosis biomarker 3: laminin 0 and 6 months
Primary Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months Liver fibrosis biomarker 4: Collagen type IV 0 and 6 months
Primary Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months Liver fibrosis biomarker 5: Glycocholic acid 0 and 6 months
Primary 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) 0 and 6 months
Secondary Change from baseline liver function biomarker (AST) at 6 months Liver function biomarkers 1: AST 0 and 6 months
Secondary Change from baseline liver function biomarker (ALT) at 6 months Liver function biomarkers 2: serum ALT 0 and 6 months
Secondary Change from baseline liver function biomarker (GGT) at 6 months Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT) 0 and 6 months
Secondary Change from baseline liver function biomarker (total protein) at 6 months Liver function biomarkers 4: serum total protein 0 and 6 months
Secondary Change from baseline liver function biomarker (ALP) at 6 months Liver function biomarkers 5: serum alkaline phosphatase (ALP) 0 and 6 months
Secondary Change from baseline liver function biomarker (bile acids) at 6 months Liver function biomarkers 6: serum bile acids 0 and 6 months
Secondary Change from baseline fasting blood lipid (TG) at 6 months Fasting blood lipid 1: serum triglycerides 0 and 6 months
Secondary Change from baseline fasting blood lipid (TC) at 6 months Fasting blood lipid 2: serum total cholesterol 0 and 6 months
Secondary Change from baseline fasting blood lipid (HDL-C) at 6 months Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C) 0 and 6 months
Secondary Change from baseline fasting blood lipid (LDL-C) at 6 months Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C) 0 and 6 months
Secondary Change from baseline fasting blood glucose at 6 months Fasting blood glucose: serum glucose 0 and 6 months
Secondary Change from baseline fasting blood insulin at 6 months Fasting blood insulin: serum insulin 0 and 6 months
Secondary Change from baseline systolic blood pressure at 6 months Blood pressure: systolic blood pressure 0 and 6 months
Secondary Change from baseline diastolic blood pressure at 6 months Blood pressure: diastolic blood pressure 0 and 6 months
Secondary Change from baseline Inflammatory factor (hsCRP ) at 6 months Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP) 0 and 6 months
Secondary Change from baseline Inflammatory factor (IL-6) at 6 months Inflammatory factor 2: serum IL-6 0 and 6 months
Secondary Change from baseline oxidative stress (SOD) at 6 months Oxidative stress biomarker 1: serum SOD 0 and 6 months
Secondary Change from baseline oxidative stress (MDA) at 6 months Oxidative stress biomarker 2: serum malondialdehyde (MDA) 0 and 6 months
Secondary 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) 0 and 6 months
Secondary Change from baseline percentage fat mass at 6 months Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA 0 and 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05881005 - NAC- NAFLD And Cushing N/A
Recruiting NCT05220956 - Impact of Time-restricted Feeding in NAFLD N/A
Enrolling by invitation NCT04066608 - Prevalence of Advanced Fibrosis in Patients Living With HIV
Recruiting NCT04302051 - Assessment of Fatty Liver With Thermo-acoustic Device
Recruiting NCT04496895 - The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults N/A
Recruiting NCT05880316 - Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting N/A
Active, not recruiting NCT05898841 - Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load Phase 4
Completed NCT05764811 - SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity N/A
Recruiting NCT05421572 - Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Recruiting NCT06302049 - Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis Phase 1/Phase 2
Completed NCT04283942 - Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism N/A
Completed NCT01016418 - Bovine Colostrum for Patients With Non Alcoholic Fatty Liver Disease Phase 1/Phase 2
Terminated NCT04175392 - Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis Phase 1/Phase 2
Not yet recruiting NCT04191044 - Portal Hypertension in Non-alcoholic Fatty Liver Disease: Association With Cardiovascular Risk and Identification of Non-invasive Biomarkers (THESIS)
Not yet recruiting NCT06071923 - Effect of Thyroid Disorders in Liver Diseases
Recruiting NCT04525833 - Liver Disease and Other Systemic Diseases
Not yet recruiting NCT05966025 - Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD) Phase 2
Completed NCT04844450 - A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795 Phase 1
Completed NCT04367012 - Fatty Liver Among Employees at Banha University
Completed NCT05694923 - Effect of Sodium Glucose Cotransporter Inhibitors on Non Diabetic Fatty Liver Disease Patients N/A