A Clinical Study to Evaluate the Safety and Efficacy of Livercure Tablets on Patients with Liver Cirrhosis.
- Conditions
- Health Condition 1: K745- Biliary cirrhosis, unspecifiedHealth Condition 2: K745- Biliary cirrhosis, unspecified
- Registration Number
- CTRI/2022/07/043725
- Lead Sponsor
- Jammi Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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/mm3.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoints <br/ ><br>•Improved liver function as demonstrated by USG <br/ ><br>•Improved liver function as demonstrated by LFT <br/ ><br>•Change in MELD and Child-Pugh Score <br/ ><br>•Improvement in quality of life as assessed by SF 36 questionnaireTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method To evaluate the safety parameters like RFT, LFT, Hematology and biochemistry, Vitals during the studyTimepoint: Day 90, 180, 270 and 360