A Clinical Trial of Longqi Jiangzhi Decoction Against Non-alcoholic Fatty Liver Disease

Официальное название

Effect of Longqi Jiangzhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial

Обзор

The goal of this clinical trial is to learn if Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Longqi Jiangzhi decoction. Researchers will compare drug Longqi Jiangzhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Longqi Jiangzhi decoction works to treat non-alcoholic fatty liver disease. Participants will: Take drug Longqi Jiangzhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment.

Вмешательства

• Препарат Longqi Jiangzhi decoction
  Below is the composition of Longqi Jiangzhi decoction: Gentiana Scabra 5g, Astragalus membranaceus 10g, Rhizoma Alismatis 10g, Crataegus pinnatifida 10g, Citri Reticulatae Pericarpium 5g.
• Препарат Control placebo
  The control placebo is a ten-fold dilution of the Longqi Jiangzhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.

Первичные конечные точки

• controlled attenuation parameter [Срок оценки: through study completion, an average of 8 weeks]

Вторичные конечные точки (6)

• body weight [Срок оценки: through study completion, an average of 8 weeks]
• total cholesterol [Срок оценки: through study completion, an average of 8 weeks]
• triglyceride [Срок оценки: through study completion, an average of 8 weeks]
• fasting plasma glucose [Срок оценки: through study completion, an average of 8 weeks]
• alanine aminotransferase [Срок оценки: through study completion, an average of 8 weeks]
• aspartate aminotransferase [Срок оценки: through study completion, an average of 8 weeks]

Критерии участия

Критерии включения

• Age 18-50 years, both genders eligible;
• Meets the diagnostic criteria for NAFLD;
• Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
• Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
• Has not received any anti-NAFLD medication treatment in the past month;
• Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;
• Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
• Voluntarily participates in the study and signs an informed consent form.

Критерии исключения

• Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);
• Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
• Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR < 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;
• Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
• Known allergy or intolerance to any component of the study medication;
• Has participated in another clinical trial within the last three months;
• Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
• Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
• Other conditions that the researcher considers unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07320456 · LJD2025001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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