A Clinical Study to Evaluate the Safety and Efficacy of Livercure Tablets on Patients with Liver Cirrhosis.

Clinical Study to evaluate the safety and efficacy of Livercure tablets on patients with Liver Cirrhosis

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043725

Enrollment

Registered

2022-07-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K745- Biliary cirrhosis, unspecified Health Condition 2: K745- Biliary cirrhosis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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 5 Serum Sodium 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.

Design outcomes

Primary

Measure	Time frame
Primary Endpoints •Improved liver function as demonstrated by USG •Improved liver function as demonstrated by LFT •Change in MELD and Child-Pugh Score •Improvement in quality of life as assessed by SF 36 questionnaireTimepoint: 1 year	—

Secondary

Measure	Time frame
To evaluate the safety parameters like RFT, LFT, Hematology and biochemistry, Vitals during the studyTimepoint: Day 90, 180, 270 and 360	—

Countries

India

Contacts

Public ContactDisha Shetty

Samahitha Research Solutions

sri@samahitha.com6364147979

Outcome results