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Impact of Branch Chain Amino Acid (Protein) on Liver Cirrhosis Patients

Impact of branch chain amino acids(BCAA) in patient with liver cirrhosis on Muscle Mass Muscle Strength Albumin Synthesis Hospital Stay Quality of Life (QoL) & Quality Adjusted Life Years (QALYâ??s)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024762
Enrollment
100
Registered
2020-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: GROUP 1 BCAA: 1.2 g L-leucine 0.6 g L-isoleucine 0.6 g L-valine 5.7 g Saccharose BD FOR 6 MONTHS Intervention2: GROUP 1 BCAA: 1.2 g L-leucine 0.6 g L-isoleucine 0.6 g L-valine Sacchar

Sponsors

Nims University Rajasthan Jaipur India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Male and female patients between 18 and 70 years of age 2 Patients with a recorded diagnosis of cirrhosis (clinical, biochemical, radiological and endoscopy) 3 Patients willing to participate in the study by signing the informed consent form 4 Decompensated cirrhotic patient under Child Pugh score 7-12 (Grade B & Grade C)

Exclusion criteria

Exclusion criteria: 1 Patients with history of alcohol intake during the past 6 weeks 2 Patients having active malignant disease, hepatocellular carcinoma, acute liver failure, heart failure, renal failure, end-stage chronic obstructive lung disease, diabetes. 3 Patients with previous transjugular intrahepatic portosystemic shunt or those who underwent a shunt or those who underwent a shunt 4 Patients with a considerable comorbid illness, such as heart, respiratory, or renal failure 5 Patients with neurologic diseases, such as Alzheimerâ??s disease, Parkinsonâ??s disease 6 Patients with non-hepatic metabolic encephalopathies 7 Patients on psychoactive drugs, such as antidepressants or sedatives 8 Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion in the study 9 Those patients who are immunocompromised. 10 Cirrhotic patients with a serum albumin of >=3.6g/dl. 11 Comatose / Stupor Pose /Intubated patients. 12 Pregnant and breast-feeding women

Design outcomes

Primary

MeasureTime frame
Improvement in nutritional parameters, Liver function tests (specifically for albumin synthesis), Child Pughâ??s Score / MELD Score and Health related Quality of Life (HRQOL).Timepoint: Baseline, 4 Weeks, 12 Weeks, 24 Weeks

Secondary

MeasureTime frame
The secondary outcomes will be assessed by measuring reduction in number of hospital admissions, Number of days of hospital stay, Rate of hospitalization and development of Hepatic Encephalopathy/death.Timepoint: Baseline, 4 Weeks, 12 Weeks, 24 Weeks

Countries

India

Contacts

Public ContactDeepak Nathiya

Department of Pharmacy Practice

deepaknathiya@gmail.com9929600137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026