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Could a herbal granule help treat stomach infection and fatty liver together?

NCT ID NCT07159412

Disease control Sponsor: Nanjing First Hospital, Nanjing 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding a traditional Chinese medicine granule (Huazhi Rougan) to standard antibiotics can better treat both H. pylori infection and metabolic-associated fatty liver disease (MASH). About 286 adults with both conditions will receive either the herbal granule or a placebo, plus a two-week course of vonoprazan and amoxicillin. The main goal is to see if the combination improves H. pylori eradication rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Huazhi Rougan Granule (a traditional Chinese medicine granule) combined with vonoprazan and amoxicillin (antibiotics)
What this could lead to
If it works, this could offer a new way to treat both H. pylori infection and fatty liver disease at the same time, potentially improving outcomes for people with both conditions.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The herbal granule may not add benefit over standard antibiotics, and side effects are not yet well understood.

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 286 people

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

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

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. Aged 18-65 years; 2. Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern; 3. Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test); 4. Signed informed consent form. Exclusion Criteria: 1. Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver; 2. Patients with severe fatty liver accompanied by ascites, edema, hyponatremia, hypokalemia, or other signs suggestive of cirrhosis; those with hepatitis or cirrhosis caused by viruses, drug toxicity, autoimmune diseases, or other factors; 3. Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation; 4. Pregnant or lactating women; 5. Patients with severe primary cardiovascular, renal, or other life-threatening diseases; 6. Individuals with a history of cancer; 7. Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels; 8. Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse; 9. Those with known hypersensitivity to any component of the study drug; 10. Participation in another clinical trial within 3 months prior to screening; 11. Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening; 12. Individuals deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Helicobacter pylori infectious disease metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

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

Helicobacter pylori infection High-dose dual therapy Huazhi rougan granule Metabolic-associated steatohepatitis

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.