Not Yet RecruitingPhase 2

The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)

Malaysia26 participantsStarted 2026-05-02

Plain-language summary

This clinical study aims to explore the potential liver-protective effects of palm tocotrienol-rich fraction (a form of Vitamin E) in adults with alcoholic fatty liver disease (AFLD). A total of 26 participants aged 18 to 65 years with AFLD will be randomly assigned to receive either tocotrienol (200 mg twice daily) or a placebo for six months. Throughout the study, participants will undergo regular liver health assessments including blood tests, FibroScan, and FibroTest, alongside evaluations of oxidative stress and inflammation markers. The study aims to determine whether tocotrienol can help improve liver function and reduce alcohol-related liver damage. Findings from this trial may provide valuable evidence for future clinical studies and highlight the potential of Malaysian palm-based tocotrienol as a natural, supportive approach to liver health.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT \>2.0, elevated GGT)
✓. Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline.
✓. Patients aged 18 to 65
✓. Patients who could comply with alcohol abstinence.

Exclusion criteria

✕. Severe alcoholic hepatitis defined as Maddrey's discriminant function \>32
✕. Patients with other concomitant liver diseases:
✕. Hepatitis B
✕. Hepatitis C
✕. Non-alcoholic fatty liver disease (NAFLD)
✕. Autoimmune hepatitis (AIH)
✕

What they're measuring

Change from baseline in Aspartate Aminotransferase (AST) at 3 and 6 months

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention

Change from baseline in Alanine Aminotransferase (ALT) at 3 and 6 months

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention.

Change from baseline in Gamma-Glutamyl Transferase (GGT) at 3 and 6 months

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention.

Between-group difference in AST at 3 and 6 months (Tocotrienol-Rich Fraction [TRF] vs placebo)

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention

Between-group difference in ALT at 3 and 6 months (TRF vs placebo)

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention

Between-group difference in GGT at 3 and 6 months (TRF vs placebo)

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention

Change from baseline in Fatty Liver Index (FLI) at 3 and 6 months

Timeframe: From enrollment to the end of treatment at 3 and 6 months post intervention

Trial details

NCT IDNCT07466485

SponsorUniversiti Kebangsaan Malaysia Medical Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-10

Contact for this trial

Siti Norain Azahar, Medicine (MD)

60-1126792792 drainazahar@gmail.com

View on ClinicalTrials.gov More Alcoholic Fatty Liver Disease trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT \>2.0, elevated GGT)
✓. Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline.
✓. Patients aged 18 to 65
✓. Patients who could comply with alcohol abstinence.

Exclusion criteria

✕. Severe alcoholic hepatitis defined as Maddrey's discriminant function \>32
✕. Patients with other concomitant liver diseases:
✕. Hepatitis B
✕. Hepatitis C
✕. Non-alcoholic fatty liver disease (NAFLD)
✕. Autoimmune hepatitis (AIH)
✕