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Can a herbal capsule slash liver cancer risk in hepatitis b patients?

NCT ID NCT07544121

Disease control Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding Babao Dan Capsule (a traditional Chinese medicine) to standard antiviral treatment can lower the chance of developing liver cancer in people with hepatitis B-related cirrhosis who are at high risk. About 1,034 adults aged 18-65 with a specific TCM syndrome and high aMAP score will be followed for 96 weeks. The goal is to see if the combination reduces liver cancer cases compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,034 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily signed informed consent form 2. Aged 18-65 years 3. Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun 4. Meeting the diagnostic criteria for hepatitis B-related cirrhosis 5. aMAP score \> 60 Exclusion Criteria: 1. Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies 2. Pregnant or lactating women 3. Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding) 4. Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury 5. Severe cardiac, renal, respiratory, or hematopoietic system diseases 6. Determined by the investigator to be unsuitable for participation in this trial

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection cirrhosis of liver hepatocellular carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis, liver Hepatitis B, chronic Hepatocellular carcinoma (HCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.