Clinical Study to evaluate the safety and efficacy of Livercure tablets on patients with Liver Cirrhosis
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Endpoints
研究概览
简要总结
This study is an open-labeled, single-arm, prospective clinical study to evaluate the safety and efficacy of Tablet Livercure Complex Forte with Nutritone granules therapy in patients diagnosed with liver cirrhosis (stages 1 and 2)
Primary Objective
ï‚· To evaluate the efficacy of Tablet. Livercure Complex Forte with Nutritone granules 12 months of therapy in subjects diagnosed with Liver Cirrhosis
ï‚· To evaluate the change in the quality of life after 12 months of treatment with Tablet. Livercure Complex forte with Nutritone granules.
Secondary Objective
ï‚· To evaluate the safety of Livercure Complex Forte with Nutritone granules in subjects diagnosed with Liver Cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients aged between 18 to 70 years with a confirmed diagnosis of liver cirrhosis (diagnosed by clinical, biochemical, sonographic or histological evidence of cirrhosis and portal hypertension).
- •2 Evidence of decompensated liver disease at screening (e.g., Child class B or C, Child-Pugh scores of ≥7).
- •3 MELD scores of at least 10 (UNOS Meld calculator).
- •4 AFP Level < 400ng/ml.
- •5 Signed informed consent.
- •6 Excessive consumption of alcohol (>30 gm of absolute alcohol/day) use in the last 3 months before screening can be included 7 Positive HBsAg or antibodies to HCV.
排除标准
- •1 Patients likely to undergo liver transplantation during the duration of the study.
- •2 Presence of advanced hepatic encephalopathy Grades 3 and 4 at the time of screening- Annexure V.
- •3 Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
- •4 Platelet count < 30,000/mm
- •5 Serum Sodium <129mEq/L.
- •6 Serum Creatinine > 2 mg/dl.
- •7 Hepatocellular carcinoma or other malignancies 8 Active infectious disease.
- •9 Presence of severe underlying cardiac, pulmonary or renal disease.
- •10 Positive antibodies to HIV 11 Pregnancy or lactating women 12 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
- •13 Unwilling/unable to sign the informed consent 14 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study.
结局指标
主要结局
Primary Endpoints
时间窗: 1 year
•Improved liver function as demonstrated by USG
时间窗: 1 year
•Improved liver function as demonstrated by LFT
时间窗: 1 year
•Change in MELD and Child-Pugh Score
时间窗: 1 year
•Improvement in quality of life as assessed by SF 36 questionnaire
时间窗: 1 year
次要结局
- To evaluate the safety parameters like RFT, LFT, Hematology and biochemistry, Vitals during the study(Day 90, 180, 270 and 360)