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NOT YET RECRUITING
NCT07639866
PHASE2

Combination of CXD and Restrictive Ketogenic Diet Against MASLD

Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-06-01

Completion Date

2027-02-01

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Low-carbon control group

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

DIETARY_SUPPLEMENT

KD group

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

DRUG

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.