Combination of CXD and Restrictive Ketogenic Diet Against MASLD (NCT07639866) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combination of CXD and Restrictive Ketogenic Diet Against MASLD
135 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 deem…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Controlled Attenuation Parameter (CAP) value
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT07639866
SponsorShanghai Municipal Hospital of Traditional Chinese Medicine