Combination of CXD and Restrictive Ketogenic Diet Against MASLD
10 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
135
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: li xing wu
- Número de teléfono: 86 15856953935
- Correo electrónico: wuxingliwxl@126.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Low-carbon control group
|
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
|
|
Experimental: KD group
|
Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Controlled Attenuation Parameter (CAP) value
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BMI
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
28 de diciembre de 2026
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- KD20260527
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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