ITMCTR2200006043
Not yet recruiting
未知
A Multicenter Randomized Controlled Clinical Trial of Electro-acupuncture in Patients with Metabolic Associated Fatty Liver Disease
ConditionsMetabolic Associated Fatty Liver Disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Metabolic Associated Fatty Liver Disease
- Sponsor
- Beijing Friendship Hospital, Capital Medical University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged 18\-65 (including 18 and 65 years old)
- •2\. The diagnosis of MAFLD according to guidelines of the Asian Pacific Association for the Study of the Liver clinical practice
- •3\. ALT\>\=1\.5 X ULN twice within 3 months
- •4\. BMI\>\=25 kg/m2
- •5\. liver fat (MRI\-PDFF) \>\=8% after run\-in period
- •6\. Sign the informed consent form.
Exclusion Criteria
- •1\. Other concomitant liver diseases such as viral hepatitis, autoimmune liver disease, drug\-induced liver disease, etc;
- •2\.Excessive drinking for 3 months or more in the 1 year before screening (the average daily consumption of ethanol for men is more than 30 grams, which is equivalent to 3\.75 units of alcohol, and for women, more than 20 grams, which is equivalent to 2\.5 units of alcohol: 1 unit \= 285 mL of beer, or strong 25mL wine, or 100mL wine);
- •3\. Those who have a history of bariatric surgery or are about to undergo bariatric surgery in the near future;
- •4\. liver cirrhosis diagnosed by histology and clinical criteria
- •5\. Type 1 diabetes patients and uncontrolled type 2 diabetes patients (HbA1c\>\=9\.5%);
- •6\. Other clinical findings before screening show any clinically significant following diseases that are unstable or untreated (including but not limited to gastrointestinal tract, nerve, blood, endocrine, tumor, lung, immune, mental diseases)
- •7\. Patients with a history of acute cardiovascular events or the following cardiovascular and cerebrovascular diseases: coronary angioplasty, stroke, transient ischemic attack, coronary heart disease;
- •8\. Are taking drugs that may cause steatosis/steatohepatitis (including amoxicillin, methotrexate, hormones, tetracycline, tamoxifen, steroids, valproic acid, etc.);
- •9\. 90 days before randomization, taking hypoglycemic drugs GLP\-1, thiazolidinedione insulin sensitizer\-related drugs, weight loss drugs (including but not limited to sibutramine, orlistat) and clinical indications may be new drugs to improve steatohepatitis (including but not limited to liraglutide, obeticholic acid, Elafibranor, vitamin E, etc.);
- •10\. Patients who have undergone acupuncture treatment within 1 month before participating in the trial
Outcomes
Primary Outcomes
Not specified
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