Combination of CXD and Restrictive Ketogenic Diet Against MASLD
10. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
135
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: li xing wu
- Telefonnummer: 86 15856953935
- E-post: wuxingliwxl@126.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Low-carbon control group
|
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
|
|
Eksperimentell: KD group
|
Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Controlled Attenuation Parameter (CAP) value
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
BMI
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
28. desember 2026
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- KD20260527
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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