跳至主要内容
临床试验/CTRI/2026/03/106216
CTRI/2026/03/106216尚未招募2 期

An Open-Label Pilot Study of OLILIV Juice to Assess Efficacy and Safety in Mild to Moderate Hepatic Dysfunctions

Medi Hero Biotech LLP1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月1日最近更新:

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

研究概览

简要总结

It’s an open-label, exploratory retrospective pilot study. The primary goal is to determine whether OLILIV Juice is effective in reducing liver enzymes (AST, ALT, AKP, GGT) from baseline to end of the study [Time Frame 8 weeks]. The single arm trial aims to recruit 24 participants who meet the selection criteria of presence of liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort), AST and ALT greater than 40 IU per L, AST and ALT ratio greater than 0.8 or BARD score equal or greater than 2. The treatment will continue for 8 weeks with 30 ml of OLILIV Juice taken twice before meals. Before and after 8 weeks of treatment, the following examinations will be performed: BMI, Efficacy Blood Test (CRP, Platelet, FBG, HbA1c, Lipid profile, LFT, GGT), and Safety Assessments (CBC, LFT, BUN, Creatinine). The endpoint variables will be analyzed using Chi-square, t-test, 95 percent confidence interval, and ANOVA, as appropriate. P-values 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

  • Presence of liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort).
  • AST and ALT greater than 40 IU per L.
  • AST and ALT ratio greater than 0.
  • BARD score equal or greater than 2.

排除标准

  • Poorly-controlled diabetes, hypertension or CKD.
  • Radiologic imaging consistent with cirrhosis or portal hypertension.
  • Participants having hypersensitive predisposition or hypersensitive to test medicine.
  • Pregnant woman, lactating woman, and woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception during the study.
  • Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

研究者

发起方
Medi Hero Biotech LLP
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Srikanta Pandit

J. B. Roy State Ayurvedic Medical College and Hospital

研究点 (1)

Loading locations...

相似试验