Combination of CXD and Restrictive Ketogenic Diet Against MASLD
10 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
135
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: li xing wu
- Numéro de téléphone: 86 15856953935
- E-mail: wuxingliwxl@126.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Low-carbon control group
|
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
|
|
Expérimental: KD group
|
Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Controlled Attenuation Parameter (CAP) value
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
BMI
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
28 décembre 2026
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
27 mai 2026
Première soumission répondant aux critères de contrôle qualité
6 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- KD20260527
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .