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 range

18 Years – 65 Years

Sex

ALL

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:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 65 Years

Sex

ALL

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: