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

Phase 3

Active, not recruiting

• Conditions: Biliary cirrhosis, unspecified. Ayurveda Condition: yakrit vriddhi, (2) ICD-10 Condition: K745||Biliary cirrhosis, unspecified. Ayurveda Condition: YAKRUJJAVIDRADHIH,

• Registration Number: CTRI/2022/07/043725
• Lead Sponsor: Jammi Pharmaceuticals Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Last Update Posted: 2023-09-19

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 30

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 < 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.

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 < 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	1 year
•Improved liver function as demonstrated by USG	1 year
•Improved liver function as demonstrated by LFT	1 year
•Change in MELD and Child-Pugh Score	1 year
•Improvement in quality of life as assessed by SF 36 questionnaire	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety parameters like RFT, LFT, Hematology and biochemistry, Vitals during the study	Day 90, 180, 270 and 360

Trial Locations

Locations (1)

Dr. Satyaprakash Centre for Digestive and Liver Diseases; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Satyaprakash Centre for Digestive and Liver Diseases

🇮🇳Bangalore, KARNATAKA, India

Dr SatyaPrakash B S

Principal investigator

6364147979

info@samahitha.com