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Ancient herb meets keto: new trial targets fatty liver

NCT ID NCT07639866

Disease control Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study tests whether a traditional Chinese medicine formula called Chazhu Xiaoli Formula (CXD), combined with a very low-carb (ketogenic) diet, can reduce liver fat in people with MASLD (fatty liver disease). 135 adults aged 18-50 will be randomly assigned to one of three groups: a low-carb diet, a ketogenic diet, or the ketogenic diet plus the herbal formula. The treatment lasts 8 weeks, followed by 8 weeks of follow-up, with liver fat measured by ultrasound.

What this could mean

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

Active substance
Chazhu Xiaoli Formula (traditional Chinese medicine compound) plus restrictive ketogenic diet
What this could lead to
If successful, this could point toward a new dietary and herbal approach to reduce liver fat and improve metabolic health in people with MASLD.
What could go wrong
This is an early Phase 2 trial with only 135 people, so results may not apply to everyone. The restrictive diet is hard to follow long-term, and the herbal formula's safety and effectiveness are not yet proven.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 135 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 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 50 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: * Age 18-50 years, regardless of gender * Meet the diagnostic criteria for MASLD * Meet the diagnostic criteria for dampness-heat accumulation syndrome in Traditional Chinese Medicine * Liver controlled attenuation parameter (CAP) ≥238 dB/m * Body mass index (BMI) ≥23 kg/m² * Possess adequate cognitive and comprehension abilities to understand the study content, its potential risks, and benefits; * Voluntarily participate in this study and personally sign the informed consent form Exclusion Criteria: * Concurrent presence of other liver diseases that may lead to hepatic steatosis, specifically including drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, viral hepatitis, and Wilson's disease * Concurrent severe dysfunction of major organs such as the heart, kidneys, or lungs, e.g., severe cardiac insufficiency (NYHA class III or higher), renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m²), or acute exacerbation of chronic obstructive pulmonary disease * Subjects currently receiving treatment for MASLD * Concurrent presence of other severe systemic diseases, such as malignant tumors or active systemic lupus erythematosus * Known hypersensitivity or intolerance to any component of the study drug * Pregnant women, lactating women, or women of childbearing age who refuse effective contraceptive measures during the trial * Participation in other clinical trials within the past 3 months * Other circumstances deemed by the investigator unsuitable for participation in this study, such as severe mental disorders affecting compliance with the study

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Masld (metabolic dysfunction-associated steatotic liver disease)

How to take part

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  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

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More trials for these conditions

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