A Non-randomized, Open-Labelled Pilot Study to Assess the Safety and Efficacy of MOLEQURE-Liver Health in Adult Subjects with Mild to Moderate Liver Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reduction in liver function biomarkers (ALT, AST, ALP, and bilirubin) throughout the study period
研究概览
简要总结
The primary objective is to assess the efficacy of MOLEQURE-Liver Health in reducing liver function parameters from baseline to the end of the study. The study is designed as a single-arm open-label pilot study in 24 participants. After selection, following inclusion and exclusion criteria, the participants will receive a 500 mg capsule (MOLEQURE-Liver Health) containing curcumin and cumin extract, twice daily for a duration of 12 weeks. The study will measure liver function biomarkers such as ALT, AST, ALP, and bilirubin, as well as improvements in clinical symptoms and the 5-item World Health Organization Well-Being Index (WHO-5). The study will also estimate safety laboratory parameters such as FBS, CBC, and kidney function tests, along with the occurrence of adverse events (AES). The statistical analysis for this study will include comparisons of efficacy variables using paired t-tests or Wilcoxon signed-rank tests, depending on the data distribution and study time points. Adverse events and other categorical data will be analyzed using frequency and percentage distributions. A p-value less than 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female volunteers aged 18-60 years.
- •Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (1x upper limit of normal or 1.5x upper limit of normal).
- •Subjects with liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort).
- •Willingness to comply with study procedures and provide written informed consent.
排除标准
- •Known diagnosis of decompensated liver disease, including but not limited to ascites, hepatic encephalopathy, or variceal bleeding.
- •History of Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection.
- •Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days.
- •History of significant alcohol consumption, defined as above 60 ml of alcohol per day.
- •Presence of severe renal impairment, congestive heart failure, or significant psychiatric disorders that, in the investigator’s opinion, could interfere with study participation.
- •Pregnant or lactating women, or women planning to become pregnant during the study period.
- •Participation in any other clinical trial within 30 days prior to the screening visit.
- •Known hypersensitivity or allergy to any component of the study intervention.
结局指标
主要结局
Reduction in liver function biomarkers (ALT, AST, ALP, and bilirubin) throughout the study period
时间窗: 12 weeks
次要结局
- Change in quality of life (QoL) from baseline as measured by 5-item World Health Organization Well-Being Index (WHO-5).(12 weeks)
研究者
Srikanta Pandit
J. B. Roy State Ayurvedic Medical College and Hospital