Milk Thistle (Silymarin) trials recruiting now

11 registrations that name milk Thistle as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.

Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.

Filter 11 registrations

Status

Phase

1US sites across 1 state

All 11 registrations

RecruitingNCT06477146

Milk Thistle Clinical Trial in Pediatric NAFLD

  • Phase 2
  • University Hospitals Cleveland Medical Center
  • About 20 people
  • Started Dec 19, 2024

In plain words A Phase 2 study of milk Thistle in people 9 to 22, run by University Hospitals Cleveland Medical Center. It plans to enroll about 20 people at 1 US site.

Who it lists and where

Who the trial lists, as registered

Lists people 9 to 22. Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD).

  • a. Elevated ALT levels greater than 2 times the sex specific upper limit of normal at baseline; (for boys ALT greater than 50 U/L, and girls ALT greater than 44 U/L) i.
  • 1\. In children, obesity is defined as BMI greater than or equal to 95th percentile in weight and overweight is defined as greater than or equal to the 85th percentile to less than the 95th percentile.
  • 2\. Risk factors associated with overweight child that warrant screening and inclusion are: a. Central obesity, Family history of NAFLD/non-alcoholic steatohepatitis(NASH), pre-diabetic or diabetic, dyslipidemia, sleep apnea)
  • 3\. For participants 18 years or older: Obesity is defined as BMI greater than or equal to 30 kg/m2; overweight is defined as BMI greater than or equal to 25 kg/m2 and less than 30 kg/m2.

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Milk thistle (MT); Placebo; Lifestyle Modification; Fibroscan

Registered summary

Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.

Where, as registered

1 US site in 1 state.

RecruitingNCT06922669

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

  • No phase
  • General Hospital of Shenyang Military Region
  • About 232 people
  • Started Jun 24, 2025

In plain words A study of milk Thistle in people 18 to 80, run by General Hospital of Shenyang Military Region. It plans to enroll about 232 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Drug Induced Liver Injury.

  • A definite diagnosis of acute DILI;
  • 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
  • Age 18-80 years old;
  • Sign the informed consent form.

The exclusion criteria are on the listing.

What it tests, as registered

Methylprednisolone; Magnesium isoglycyrrhizinate; Glutathione; Silymarin; Polyene Phosphatidylcholine; Ursodeoxycholic acid capsules; Ademetionine 1,4-Butanedisulfonate; Plaslna exchange; Liver transplantation

Registered summary

Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.

Where, as registered

No US site; China (1).

RecruitingNCT07293767

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

  • No phase
  • Ain Shams University
  • About 90 people
  • Started Nov 16, 2024

In plain words A study of milk Thistle in people 18 to 60, run by Ain Shams University. It plans to enroll about 90 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 60. Conditions: Fibromyalgia (FM).

  • Informed written consent.
  • Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia: Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
  • Age >18 years old (males and females)
  • Diagnosis of FM confirmed by a rheumatologist.

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Silymarin (LEGALON); Diosmin / Hesperidin (Daflon); no intervention (control group)

Registered summary

Fibromyalgia is a chronic disease, characterized by chronic widespread pain, physical exhaustion, sleep problems, and unexplained pain in both joints and muscles. Fibromyalgia's causes still unknown, but there are various risk factors that can cause fibromyalgia such as genetic causes, physical shock, and infections. Fibromyalgia typically presents in young or middle aged females, it occurs in females more than males, and it is characterized with widespread pain throughout the whole body in both sides such as arms, shoulders, head, and abdominal areas. The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

RecruitingNCT05689619

SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)

  • No phase
  • A.O.U. Città della Salute e della Scienza
  • About 70 people
  • Started Sep 1, 2023

In plain words A study of milk Thistle in people 18 to 70, run by A.O.U. Città della Salute e della Scienza. It plans to enroll about 70 people at 6 sites, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Brain Metastases, Adult; Non Small Cell Lung Cancer; Breast Cancer.

  • Histologically confirmed BM from NSCLC or BC by local pathology
  • Single BM (maximum diameter of 3 cm) on MRI before surgery
  • Complete surgical resection (MRI-verified within 14 days prior randomization)
  • pSTAT3 score in reactive astrocytes of peritumoral tissue confirmed by local or central assessment

20 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Silibinin; Placebo

Registered summary

This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC).

Where, as registered

No US site; Italy (6).

RecruitingNCT07001150

Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease

  • Phase 2
  • Tanta University
  • About 50 people
  • Started May 10, 2025

In plain words A Phase 2 study of milk Thistle in people 45 to 65, run by Tanta University. It plans to enroll about 50 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 45 to 65. Conditions: Parkinson Disease.

  • Age between 45 and 65 years old
  • Both sexes
  • Patients with Parkinson's disease on dopamine replacement therapy
  • Modified Hoehn and Yahr stage, MHY 1-4 (29)

The exclusion criteria are on the listing.

What it tests, as registered

levodopa-carbidopa; Silymarin

Registered summary

Parkinson's disease (PD) is a leading neurodegenerative movement disorder, marked by a gradual loss of dopamine-producing neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein protein aggregates. Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, will be studied for its neuroprotective effects in PD.

Where, as registered

No US site; Egypt (1).

RecruitingNCT06213857

Beneficial Effect of Silymarin in Ulcerative Colitis

  • Phase 2
  • Tanta University
  • About 44 people
  • Started Feb 1, 2025

In plain words A Phase 2 study of milk Thistle in people 18 to 65, run by Tanta University. It plans to enroll about 44 people at 2 sites, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Ulcerative Colitis.

  • Adults of both sexes aged from 18 years to 65 years.
  • Adults with normal kidney and liver functions.
  • Patients who sign the consent and willing to participate in the study.
  • Patients with UC according to American College of Gastroenterology Clinical Guidelines for diagnosis Ulcerative Colitis having clinical signs and symptoms with a completed medical workup, colonoscopy, pathological and laboratory data…

The exclusion criteria are on the listing.

What it tests, as registered

Silymarin; Mesalamine; Azathioprine

Registered summary

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The full summary is on the listing.

Where, as registered

No US site; Egypt (2).

RecruitingNCT07024966

Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress

  • No phase
  • Fundació Eurecat
  • About 14 people
  • Started Aug 1, 2025

In plain words A study of milk Thistle in male participants 18 to 50, run by Fundació Eurecat. It plans to enroll about 14 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists male participants 18 to 50; healthy volunteers accepted. Conditions: Oxidative Stress; Physical Activity; Antioxidant Effect.

  • Male participants between 18 and 50 years of age who are amateur runners.
  • Engage in at least 3 continuous running sessions per week, each lasting 60 minutes, which corresponds to a high level of physical activity according to the International Physical Activity Questionnaire (IPAQ).*
  • Self-report being able to continuously run for 45 minutes at high intensity without difficulty.
  • Provide signed informed consent prior to participation in the study.

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Pterostilbene-silybin-nicotinamide riboside; Control Group

Registered summary

This study aims to evaluate the effects of the dietary supplement ccPT-SIL-NR, which contains pterostilbene (ccPT), silybin (SIL), and nicotinamide riboside (NR), on oxidative stress markers after a high-intensity exercise session. The primary objective is to assess changes in blood malondialdehyde (MDA) levels. The full summary is on the listing.

Where, as registered

No US site; Spain (1).

Not yet recruitingNCT07058090

Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi

  • Phase 1
  • Liaquat National Hospital & Medical College
  • About 410 people
  • Starts Jul 2025 (estimated)

In plain words A Phase 1 study of milk Thistle in people 40 to 80, run by Liaquat National Hospital & Medical College. It plans to enroll about 410 people and lists no sites yet.

Who it lists and where

Who the trial lists, as registered

Lists people 40 to 80. Conditions: Drug Induced Liver Injury; Tuberculosis (TB).

  • Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age
  • either gender.

The exclusion criteria are on the listing.

What it tests, as registered

Silymarin 420 mg; N Acetyl Cysteine; Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Registered summary

OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi. SAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV)… The full summary is on the listing.

Where, as registered

No sites listed yet.

Not yet recruitingNCT07863648

Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

  • Phase 3
  • Kafrelsheikh University
  • About 120 people
  • Starts Oct 16, 2026 (estimated)

In plain words A Phase 3 study of milk Thistle in people 18 to 65, run by Kafrelsheikh University. It plans to enroll about 120 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Metabolic Dysfunction-Associated Steatoic Liver Disease.

  • Adults (18-65 y),
  • Diagnosed with MASLD (CAP ≥248 dB/m on FibroScan, ALT >40 IU/L),
  • Non-diabetic (HbA1c <6.5%, fasting glucose <126 mg/dL),
  • BMI 25-40 kg/m²,

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Vitamin E 800 IU/d; Silymarin 420 mg; Placebo

Registered summary

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

Not yet recruitingNCT07572552

Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis

  • Phase 2
  • Tanta University
  • About 66 people
  • Starts May 2026 (estimated)

In plain words A Phase 2 study of milk Thistle in people 18 and older, run by Tanta University. It plans to enroll about 66 people and lists no sites yet.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Sepsis.

  • Adult age ≥18 years old. Both male and female patients. Patients diagnosed with sepsis regardless of its etiology, according to the definitions of the Surviving Sepsis Campaign (SSC)

The exclusion criteria are on the listing.

What it tests, as registered

Fenofibrate; Silymarin

Registered summary

Sepsis is a life-threatening condition defined by organ dysfunction resulting from the body's dysregulated response to an infection (1). It begins with widespread inflammation and cellular damage, which quickly escalates into total circulatory failure and the breakdown of essential organ systems, including the lungs, kidneys, digestive tract, and brain. This study aims at evaluating the safety and efficacy of fenofibrate versus silymarin for adult patients with sepsis.

Where, as registered

No sites listed yet.

Not yet recruitingNCT07833514

Misocholic Tablets for Non-Viral Elevated Liver Enzymes

  • Phase 3
  • Hanoi Medical University
  • About 60 people
  • Starts Sep 15, 2026 (estimated)

In plain words A Phase 3 study of milk Thistle in people 18 and older, run by Hanoi Medical University. It plans to enroll about 60 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Alcohol-Related Liver Disease; Drug-Induced Liver Injury; Non-alcoholic Fatty Liver Disease.

  • Adults aged 18 years or older.
  • Mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) at screening, defined as ALT and/or AST ≥2 to <5 times the upper limit of normal (ULN) according to the reference range of the study…
  • Elevated liver enzymes primarily associated with one of the following conditions:
  • Alcohol-related liver disease (ALD), defined by: History of hazardous alcohol consumption for at least the previous 3 months (average ethanol intake ≥40 g/day for men or ≥20 g/day for women); Elevated ALT and/or AST consistent with…

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Misocholic Tab; Placebo; Silymarin (Silybum marianum)

Registered summary

Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited. The full summary is on the listing.

Where, as registered

No US site; Vietnam (1).

ClinicalTrials.gov lists 20 open registrations for this search, including ones where milk Thistle is not a study arm or that are past the 11 we keep. Search them on ClinicalTrials.gov (opens in new tab).

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