Randomized Comparative Clinical Study of the Dietary Supplement "Gepaktiv" (International Name: Phenomenon) in Comparison With Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients With Metabolic Associated Fatty Liver Disease (MAFLD) and Hepatomegaly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in ALT levels by ≥30% from baseline
研究概览
简要总结
This study compares the effectiveness of the dietary supplement Gepaktiv with standard medications (UDCA and Ademetionine) in patients with fatty liver disease (MAFLD) and liver enlargement (hepatomegaly).
Key points:
- Participants will receive either Gepaktiv, UDCA, or Ademetionine for 15 days
- Doctors will monitor liver health through blood tests and ultrasound scans
- The study will check if Gepaktiv helps improve liver function as effectively as standard treatments.
Main measurements:
- Changes in liver enzyme levels (ALT, AST)
- Reduction in liver size
- Improvement in fat accumulation (steatosis) measured by FibroScan This research may provide evidence for a new natural option to support liver health.Data analysis will be done by an independent biostatistics
详细描述
This randomized, open-label, parallel-group study evaluates the hepatoprotective effects of the dietary supplement Gepaktiv (250 mg capsules) compared to ursodeoxycholic acid (UDCA) and ademetionine in 90 patients with metabolic-associated fatty liver disease (MAFLD) and hepatomegaly.
Study Design:
- Duration: 15-day treatment with optional 60-day follow-up
- 3 treatment arms (n=30 each):
- Gepaktiv (2 capsules × 3 times daily)
- UDCA (10-15 mg/kg/day)
- Ademetionine (800-1600 mg/day)
- Randomization: 1:1:1 block randomization
Primary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Biochemical and imaging data are evaluated by independent assessors blinded to group assignment. Outcome assessors do not have access to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD)
- •Hepatomegaly confirmed by ultrasound (≥3 cm craniocaudal liver enlargement)
- •ALT level between 90-150 U/L
- •Steatosis ≥260 dB/m by FibroScan (CAP)
- •Fibrosis ≥11 kPa by transient elastography (FibroScan)
- •Ability to comply with study procedures
- •Signed informed consent
排除标准
- •Liver cirrhosis or hepatocellular carcinoma
- •Pregnancy or lactation
- •Known allergy to any of the study medications or supplement components
- •Gallstones or biliary obstruction
- •Shrunken liver on imaging
- •Hepatic cysts (simple liver cysts/biliary cysts)
- •Liver nodules (focal liver lesions)
研究组 & 干预措施
Group 2 (n=30)
Group 2 (n=30): UDCA 10-15 mg/kg/day;
干预措施: UDCA (Ursodeoxycholic acid) (Drug)
Group 3 (n=30)
Group 3 (n=30): Ademetionine 800-1600 mg/day.
干预措施: Ademetionine (Drug)
Group 1 (n=30)
Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals
干预措施: Dietary supplement "Gepaktiv" (Combination Product)
结局指标
主要结局
Reduction in ALT levels by ≥30% from baseline
时间窗: 15 days (+ optional post-observation up to 60 days).
Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment
Change in liver size (ultrasound)
时间窗: 15 days (+ optional post-observation up to 60 days).
Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound
Improvement in steatosis/fibrosis (FibroScan)
时间窗: 15 days (+ optional post-observation up to 60 days).
Change in CAP (steatosis) and kPa (fibrosis) scores from baseline
次要结局
未报告次要终点