NCT07639866Not yet recruitingPhase 2
Combination of CXD and Restrictive Ketogenic Diet Against MASLD
Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 27 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 28 Dec 2026
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07639866
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 135
- From 1 Jul 2026 to the primary completion date, 28 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known hypersensitivity or intolerance to any component of the study drug
- Other circumstances deemed by the investigator unsuitable for participation in this study, such as severe mental disorders affecting compliance with the study
Age
- Pregnant women, lactating women, or women of childbearing age who refuse effective contraceptive measures during the trial
Other
- Participation in other clinical trials within the past 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.