ITMCTR2100004877RecruitingPhase 1
A Randomly Controlled Clinical Trial of electro-acupuncture in Patients with Non-alcoholic Steatohepatitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- All
Inclusion Criteria
- •1. Male or female patients aged 18-65 (including 18 and 65 years old);
- •2. Imaging shows fatty liver (B-ultrasound or CT or NMR);
- •3. NASH diagnosis or NASH phenotype diagnosis
- •(1) NASH diagnosis: there is a medical history that proves histological evidence of NASH by liver pathological biopsy within 6 months before screening or during the screening period (NAS score >= 4 points, including inflammation and ballooning at least 1 point each, fibrosis level <=F3), no other chronic liver diseases were found in histological diagnosis and ALT>=1.5 X ULN;
- •(2) NASH phenotypic diagnosis: ALT>=1.5 X ULN and BMI>=25 kg/m2 and liver fat >=8% at baseline (MRI-PDFF) in two examinations with an interval greater than 7 days within 3 months;
- •4. Sign the informed consent form.
Exclusion Criteria
- •1. 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);
- •2. Those who have a history of bariatric surgery or are about to undergo bariatric surgery in the near future; Type 3.1 diabetes patients and uncontrolled type 2 diabetes patients (HbA1c>=9.5%);
- •4. 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)
- •5. Patients with a history of acute cardiovascular events or the following cardiovascular and cerebrovascular diseases: coronary angioplasty, stroke, transient ischemic attack, coronary heart disease;
- •6. Are taking drugs that may cause steatosis/steatohepatitis (including amoxicillin, methotrexate, hormones, tetracycline, tamoxifen, steroids, valproic acid, etc.);
- •7. 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.);
- •8. Patients who have undergone acupuncture treatment within 1 month before participating in the trial;
- •9. Women who are pregnant or breastfeeding or who have recently had a childbirth need without contraception;
- •10. Patients with contraindications for MRI scanning (prostheses with metal fillers, tight space syndrome, etc.);
- •11. Patients with a weight change of more than 5% in the 8 weeks before randomization;
- •12. According to the researcher's judgment, it is not suitable to participate in the research.
Investigators
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