Nonalcoholic Fatty Liver DiseaseNCT05497765
An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease
A study testing Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza and Silibinin extract in people with Nonalcoholic Fatty Liver Disease, run by Guangzhou Medical University at 1 site in China.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza and Silibinin extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 20 Feb 2024
- 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
- Subject's BMI is ≥ 22.0 kg/m2 and < 33.0 kg/m2;
- Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018;
- A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio < 1.0;
- Must be able to swallow tablets.
Who cannot join
- ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
- Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
- Be taking medicines or supplements that would influence the liver function, lipid metabolism;
- Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc;
- Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease;
- Body weight change are more than 10% in previous 3 months;
Show all 11Show fewer
- Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product;
- Subjects are allergic to the ingredients in the test or control samples;
- Woman who is pregnant or breastfeeding;
- Subjects cannot meet the requirements of compliance in the pre-experiment period;
- Subjects who fail to sign the informed consent forms.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nutrition, School of Public Health, Guangdong Medical University
Dongguan, Guangdong, 523808
About this study
Official title: Effects of Compound Silymarin on Biomarkers of Lipid Metabolism and Inflammation in Patients With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Double-blind Trial
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza, Silibinin extract, Placebo
- Keywords
- Nonalcoholic fatty liver disease, Silymarin, Inflammation, Lipid metabolism
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhizaDietary supplement
Take 4 tablets with warm water twice a day
Silibinin extractDietary supplement
Take 4 tablets with warm water twice a day
PlaceboDietary supplement
Take 4 tablets with warm water twice a day
| Study group | Role | What they receive |
|---|---|---|
| Compound silymarin | Experimental | Dietary supplement: 4 tablets of compound silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin, mixed power of pueraria, schisandra and salvia miltiorrhiza Receives: Dietary Supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza |
| Silymarin | Active comparator | Dietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin Receives: Dietary Supplement: Silibinin extract |
| Placebo | Placebo comparator | Dietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver enzymes
Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)
Measured: Change from baseline ALT and AST at 12 weeks
Lipid profile
Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)
Measured: Change from baseline lipid profile at 12 weeks
Secondary outcomes (2)
T-Lymphocytes' composition
Changes of T-Lymphocytes' composition in peripheral blood
Measured: Change from baseline T-Lymphocytes' composition at 12 weeks
Bile acid metabolism
Composition of serum and fecal bile acids
Measured: Change from baseline composition of serum and fecal bile acids at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Jan 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University
- Responsible party
- Principal investigator, Honghui Guo, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497765
- Sponsor's protocol ID
- GDMUSPH001
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aghemo A, Alekseeva OP, Angelico F, Bakulin IG, Bakulina NV, Bordin D, Bueverov AO, Drapkina OM, Gillessen A, Kagarmanova EM, Korochanskaya NV, Kucheryavii UA, Lazebnik LB, Livzan MA, Maev IV, Martynov AI, Osipenko MF, Sas EI, Starodubova A, Uspensky YP, Vinnitskaya EV, Yakovenko EP, Yakovlev AA. Role of silymarin as antioxidant in clinical management of chronic liver diseases: a narrative review. Ann Med. 2022 Dec;54(1):1548-1560. doi: 10.1080/07853890.2022.2069854.
PubMed 35635048Malik A, Nadeem M, Malik MI. Efficacy of elafibranor in patients with liver abnormalities especially non-alcoholic steatohepatitis: a systematic review and meta-analysis. Clin J Gastroenterol. 2021 Dec;14(6):1579-1586. doi: 10.1007/s12328-021-01491-7. Epub 2021 Aug 9.
PubMed 34370218Kalopitas G, Antza C, Doundoulakis I, Siargkas A, Kouroumalis E, Germanidis G, Samara M, Chourdakis M. Impact of Silymarin in individuals with nonalcoholic fatty liver disease: A systematic review and meta-analysis. Nutrition. 2021 Mar;83:111092. doi: 10.1016/j.nut.2020.111092. Epub 2020 Nov 25.
PubMed 33418491Navarro VJ, Belle SH, D'Amato M, Adfhal N, Brunt EM, Fried MW, Reddy KR, Wahed AS, Harrison S; Silymarin in NASH and C Hepatitis (SyNCH) Study Group. Silymarin in non-cirrhotics with non-alcoholic steatohepatitis: A randomized, double-blind, placebo controlled trial. PLoS One. 2019 Sep 19;14(9):e0221683. doi: 10.1371/journal.pone.0221683. eCollection 2019.
PubMed 31536511Zhong S, Fan Y, Yan Q, Fan X, Wu B, Han Y, Zhang Y, Chen Y, Zhang H, Niu J. The therapeutic effect of silymarin in the treatment of nonalcoholic fatty disease: A meta-analysis (PRISMA) of randomized control trials. Medicine (Baltimore). 2017 Dec;96(49):e9061. doi: 10.1097/MD.0000000000009061.
PubMed 29245314Wah Kheong C, Nik Mustapha NR, Mahadeva S. A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1940-1949.e8. doi: 10.1016/j.cgh.2017.04.016. Epub 2017 Apr 15.
PubMed 28419855
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compound Silymarin on Biomarkers of Lipid Metabolism and Inflammation in Patients With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT05497765
- Acronym / sponsor ID
- GDMUSPH001
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic fatty liver disease, Silymarin, Inflammation, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 11 Aug 2022 (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 (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Compound silymarin | Experimental | Dietary Supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhizaDietary supplement: 4 tablets of compound silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin, mixed power of pueraria, schisandra and salvia miltiorrhiza |
| Silymarin | Active comparator | Dietary Supplement: Silibinin extractDietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject's BMI is ≥ 22.0 kg/m2 and < 33.0 kg/m2;
- Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018;
- A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio < 1.0;
- Must be able to swallow tablets.
Key exclusion criteria (11 listed)
- ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
- Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
- Be taking medicines or supplements that would influence the liver function, lipid metabolism;
- Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc;
- Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease;
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 |
|---|---|---|
| Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhizaTake 4 tablets with warm water twice a day | Dietary supplement | Compound silymarin |
| Silibinin extractTake 4 tablets with warm water twice a day | Dietary supplement | Silymarin |
| PlaceboTake 4 tablets with warm water twice a day | Dietary supplement | Placebo |
Primary outcome
Liver enzymes
Time frame: Change from baseline ALT and AST at 12 weeks
Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)
Lipid profile
Time frame: Change from baseline lipid profile at 12 weeks
Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)
2 secondary outcomes
T-Lymphocytes' composition
Time frame: Change from baseline T-Lymphocytes' composition at 12 weeks
Bile acid metabolism
Time frame: Change from baseline composition of serum and fecal bile acids at 12 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 28 Feb 2024.
- Background: PubMed 35635048Aghemo A, Alekseeva OP, Angelico F, Bakulin IG, Bakulina NV, Bordin D, Bueverov AO, Drapkina OM, Gillessen A, Kagarmanova EM, Korochanskaya NV, Kucheryavii UA, Lazebnik LB, Livzan MA, Maev IV, Martynov AI, Osipenko MF, Sas EI, Starodubova A, Uspensky YP, Vinnitskaya EV, Yakovenko EP, Yakovlev AA. Role of silymarin as antioxidant in clinical management of chronic liver diseases: a narrative review. Ann Med. 2022 Dec;54(1):1548-1560. doi: 10.1080/07853890.2022.2069854.
- Background: PubMed 34370218Malik A, Nadeem M, Malik MI. Efficacy of elafibranor in patients with liver abnormalities especially non-alcoholic steatohepatitis: a systematic review and meta-analysis. Clin J Gastroenterol. 2021 Dec;14(6):1579-1586. doi: 10.1007/s12328-021-01491-7. Epub 2021 Aug 9.
- Background: PubMed 33418491Kalopitas G, Antza C, Doundoulakis I, Siargkas A, Kouroumalis E, Germanidis G, Samara M, Chourdakis M. Impact of Silymarin in individuals with nonalcoholic fatty liver disease: A systematic review and meta-analysis. Nutrition. 2021 Mar;83:111092. doi: 10.1016/j.nut.2020.111092. Epub 2020 Nov 25.
- Background: PubMed 31536511Navarro VJ, Belle SH, D'Amato M, Adfhal N, Brunt EM, Fried MW, Reddy KR, Wahed AS, Harrison S; Silymarin in NASH and C Hepatitis (SyNCH) Study Group. Silymarin in non-cirrhotics with non-alcoholic steatohepatitis: A randomized, double-blind, placebo controlled trial. PLoS One. 2019 Sep 19;14(9):e0221683. doi: 10.1371/journal.pone.0221683. eCollection 2019.
- Background: PubMed 29245314Zhong S, Fan Y, Yan Q, Fan X, Wu B, Han Y, Zhang Y, Chen Y, Zhang H, Niu J. The therapeutic effect of silymarin in the treatment of nonalcoholic fatty disease: A meta-analysis (PRISMA) of randomized control trials. Medicine (Baltimore). 2017 Dec;96(49):e9061. doi: 10.1097/MD.0000000000009061.
- Background: PubMed 28419855Wah Kheong C, Nik Mustapha NR, Mahadeva S. A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1940-1949.e8. doi: 10.1016/j.cgh.2017.04.016. Epub 2017 Apr 15.
- Individual participant dataSharing planned: No
Related trials for Nonalcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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 Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza and Silibinin extract in people with Nonalcoholic Fatty Liver Disease, run by Guangzhou Medical 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 11 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 28 Feb 2024. 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?
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?
Liver enzymes (time frame: Change from baseline ALT and AST at 12 weeks). The study lists 2 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 NCT05497765, which also lists 6 linked publications.
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 28 Feb 2024.