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Combination of CXD and Restrictive Ketogenic Diet Against MASLD

10 juli 2026 bijgewerkt door: Shanghai Municipal Hospital of Traditional Chinese Medicine

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

135

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Low-carbon control group
Voedingssupplement: Low-carbon control group
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
Experimenteel: KD group
Voedingssupplement: KD group
Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
Experimenteel: CXD and KD group
Geneesmiddel: CXD and KD group
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Controlled Attenuation Parameter (CAP) value
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use an elastography ultrasound device to measure liver fat content
From enrollment to the end of treatment at 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
BMI
Tijdsspanne: From baseline to the end of the 8-week follow-up period
From baseline to the end of the 8-week follow-up period
Triglyceride(TG)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure TG
From enrollment to the end of treatment at 8 weeks
Total blood cholesterol(TC)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure TC
From enrollment to the end of treatment at 8 weeks
High-Density Lipoprotein(HDL)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure HDL
From enrollment to the end of treatment at 8 weeks
Alanine Aminotransferase (ALT)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure liver function
From enrollment to the end of treatment at 8 weeks
Aspartate Aminotransferase(AST)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure liver function
From enrollment to the end of treatment at 8 weeks
Gamma-Glutamyl Transferase(GGT)
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure liver function
From enrollment to the end of treatment at 8 weeks
Blood glucose metabolism indicators
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure blood glucose
From enrollment to the end of treatment at 8 weeks
Traditional Chinese Medicine Syndrome Scoring System
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results.
From enrollment to the end of treatment at 8 weeks
Blood ketones
Tijdsspanne: From baseline to the end of the 8-week follow-up period
Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety
From baseline to the end of the 8-week follow-up period
Creatinine
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety
From enrollment to the end of treatment at 8 weeks
Blood Urea Nitrogen
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety
From enrollment to the end of treatment at 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

28 december 2026

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • KD20260527

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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