Impact of Branch Chain Amino Acid (Protein) on Liver Cirrhosis Patients
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2020/04/024762
- Lead Sponsor
- ims University Rajasthan Jaipur India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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