Open-Label, Prospective, Randomized, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of Dipya Liver Care Tablet in the Management of Non alcoholic fatty liver disease (NAFLD)
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1 Mean change in liver function as assessed by Liver Function Tests over 90 days
研究概览
简要总结
Vedistry Liver Care Tablet is an Ayurvedic formulation designed for liver detoxification, managing Non-Alcoholic Fatty Liver Disease (NAFLD), hepatitis, alcoholic liver disease, cirrhosis, and compromised liver function. It claims to enhance liver function, reduce hepatic fat and lipid levels, and improve digestion.
A Phase IV Open-Label, Prospective, Randomized, Single-Arm Clinical Trial involving 35 participants over 90 days evaluates its efficacy and safety. Participants visit at baseline (Day 0), Day 30, Day 60, and Day 90, with assessments of liver function, lipid profiles, and digestive health. Primary endpoints include changes in liver function tests (AST, ALT, Bilirubin), hepatic fat reduction via Fibroscan, and improved digestion measured by the Digestion Quality of Life (DQLQ) and Gastrointestinal Symptom Rating Scale (GSRS). Secondary endpoints include lipid profile improvements (cholesterol, triglycerides) and liver stiffness reduction. Safety evaluations encompass hematological, renal, and physical examinations, along with monitoring for adverse events.
Participants receive 1 tablet twice daily after meals. Key exclusions include individuals with significant liver diseases beyond NAFLD, viral hepatitis, autoimmune hepatitis, active alcohol or drug use, and specific medical conditions. Ethical guidelines, including informed consent and adherence to Good Clinical Practice (GCP), are strictly followed.
The trial aims to validate Vedistry Liver Care Tablet as a safe and effective option for improving liver health and metabolic function, positioning it as a promising Ayurvedic solution for NAFLD and related conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male or female participants aged 18-45 years diagnosed with NAFLD Grade II 2 Participants with abnormal liver function tests indicative of NAFLD 3 Completed the screening process within 3 days prior to randomization 4 Study participants have understood and signed the informed consent form to participate in the study 5 Study participants willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document.
排除标准
- •KEY EXCLUSION CRITERIA.
- •Participants with significant hepatic disease other than NAFLD (e.g., viral hepatitis, alcoholic liver disease, Liver ci).
- •History of major gastrointestinal surgery or liver transplantation.
- •Pregnant or lactating women.
- •Concurrent use of hepatotoxic drugs or participation in another clinical trial within the past 30 days. 5.Alcohol consumption: Excessive alcohol consumption, defined as more than 20 grams per day for men and more than 10 grams per day for women, within two years of entry 6.Viral infection: Evidence of hepatitis B or C infection 7.Autoimmune or liver condition: History of autoimmune hepatitis, Wilson's disease, or other underlying liver conditions 8.Other conditions: Short bowel syndrome, suspected or confirmed hepatocellular carcinoma, HIV positivity, low alpha-1-antitrypsin level, glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis, vascular lesions, iron overload, and more 9.Active drug use: Active drug use or dependence that would interfere with follow-up.
结局指标
主要结局
1 Mean change in liver function as assessed by Liver Function Tests over 90 days
时间窗: 1 Screening Day Before 2 to 4 | 2 Visit 1 Day 0 | Randomization in study | 3. Visit 2 Day 30 | 4. Visit 3 Day 60 | 5. Visit 4 Day 90
2 Reduction in hepatic stiffness and scarring measured by Fibro scan at baseline and day 90
时间窗: 1 Screening Day Before 2 to 4 | 2 Visit 1 Day 0 | Randomization in study | 3. Visit 2 Day 30 | 4. Visit 3 Day 60 | 5. Visit 4 Day 90
3 Improved digestive health using the Digestion associated quality of Life and
时间窗: 1 Screening Day Before 2 to 4 | 2 Visit 1 Day 0 | Randomization in study | 3. Visit 2 Day 30 | 4. Visit 3 Day 60 | 5. Visit 4 Day 90
Gastrointestinal Symptom Rating Scale
时间窗: 1 Screening Day Before 2 to 4 | 2 Visit 1 Day 0 | Randomization in study | 3. Visit 2 Day 30 | 4. Visit 3 Day 60 | 5. Visit 4 Day 90
4 Changes in Lipid Profile over 90 days
时间窗: 1 Screening Day Before 2 to 4 | 2 Visit 1 Day 0 | Randomization in study | 3. Visit 2 Day 30 | 4. Visit 3 Day 60 | 5. Visit 4 Day 90
次要结局
- SECONDARY ENDPOINT -(1. Safety evaluations based on hematological (ESR, Leukocyte) and renal function tests (RFTs))
研究者
Dr V R Borakhade
Yashwant Ayurvedic College PGTand RC Kodoli