AzTrials
AzTrials

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Phase 2NCT07639866

Combination of CXD and Restrictive Ketogenic Diet Against MASLD

A Phase 2 study testing KD group and CXD and KD group in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Shanghai Municipal Hospital of Traditional Chinese Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial. A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
KD group and CXD and KD group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 1 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

li xing wu contact

86 15856953935

wuxingliwxl@126.com

About this study

Official title: Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD

This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial. A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha Lipid-Reducing Formula combined with a restrictive ketogenic diet. The trial duration consisted of 8 weeks of treatment followed by 8 weeks of follow-up. During the trial, participants adhered to dietary calorie control and moderate exercise as instructed in health education, self-reported their height, weight, waist-to-hip ratio, and other general parameters, and had weekly blood ketone level monitoring. Liver ultrasound, fasting blood glucose, lipid profiles, blood ketones, liver function tests, serum creatinine, urea nitrogen levels, and scores on the Traditional Chinese Medicine Syndrome Scale were measured before treatment initiation and at the end of the 8-week treatment period.

Being tested
Low-carbon control group, KD group, CXD and KD group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-carbon control groupDietary supplement

    The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).

  • KD groupDietary supplement

    Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).

  • CXD and KD groupDrug

    In addition to a restrictive ketogenic diet intervention, the patients were administered a traditional Chinese medicine compound formula named Chazhu Xiaoli Formula for lipid reduction. Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.

Study groups in NCT07639866
Study groupRoleWhat they receive
Low-carbon control groupPlacebo comparatorNot described
Receives: Dietary Supplement: Low-carbon control group
KD groupExperimentalNot described
Receives: Dietary Supplement: KD group
CXD and KD groupExperimentalNot described
Receives: Drug: CXD and KD group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Controlled Attenuation Parameter (CAP) value

    Use an elastography ultrasound device to measure liver fat content

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (12)

  1. BMI

    Measured: From baseline to the end of the 8-week follow-up period

  2. Triglyceride(TG)

    Use a fully automated biochemical analyzer to measure TG

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Total blood cholesterol(TC)

    Use a fully automated biochemical analyzer to measure TC

    Measured: From enrollment to the end of treatment at 8 weeks

  4. High-Density Lipoprotein(HDL)

    Use a fully automated biochemical analyzer to measure HDL

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Alanine Aminotransferase (ALT)

    Use a fully automated biochemical analyzer to measure liver function

    Measured: From enrollment to the end of treatment at 8 weeks

  6. Aspartate Aminotransferase(AST)

    Use a fully automated biochemical analyzer to measure liver function

    Measured: From enrollment to the end of treatment at 8 weeks

  7. Gamma-Glutamyl Transferase(GGT)

    Use a fully automated biochemical analyzer to measure liver function

    Measured: From enrollment to the end of treatment at 8 weeks

  8. Blood glucose metabolism indicators

    Use a fully automated biochemical analyzer to measure blood glucose

    Measured: From enrollment to the end of treatment at 8 weeks

  9. Traditional Chinese Medicine Syndrome Scoring System

    The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results.

    Measured: From enrollment to the end of treatment at 8 weeks

  10. Blood ketones

    Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety

    Measured: From baseline to the end of the 8-week follow-up period

  11. Creatinine

    Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety

    Measured: From enrollment to the end of treatment at 8 weeks

  12. Blood Urea Nitrogen

    Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639866
Sponsor's protocol ID
KD20260527
Status last verified
Jun 2026
First submitted
27 May 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KD group and CXD and KD group in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Shanghai Municipal Hospital of Traditional Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact li xing wu (86 15856953935, wuxingliwxl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Controlled Attenuation Parameter (CAP) value (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07639866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in