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Amino Acid

Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C

Phase 3
Waitlist Available
Led By Sandeep s Sidhu, DM
Research Sponsored by Dayanand Medical College and Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month
Awards & highlights
Pivotal Trial

Summary

Sarcopenia is defined as loss of skeletal muscle mass. In cirrhosis, due to impaired urea genesis and decreased hepatic ammonia disposal, the skeletal muscle functions as a metabolic partner for the liver. The proportion of patients with sarcopenia is higher in those with alcoholic liver cirrhosis (80%) compared to cirrhosis due to other etiologies (31%-71%). Sarcopenia is prevalent in \> 50% patients with Child C cirrhosis. Sarcopenia increases the risk for severe infections in patients with cirrhosis. Adequate amino acid supply is needed for appropriate antibody and cytokine responses, that is impaired when skeletal muscle mass. The sepsis-related mortality rates in patients with and without sarcopenia are 22% and 8%, respectively (P = 0.02). In patients with liver cirrhosis is protein-calorie malnutrition, leading to severe consequences to the general state and clinical evolution of the patient.

Eligible Conditions
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CT Skeletal muscle index (cm2/m2)
Change in Hand Grip Strength (Kilograms)
Secondary study objectives
Change in Quality of life: SF 36 Scale
Change in muscle performance
Event-free survival

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Branched Chain Amino AcidExperimental Treatment1 Intervention
Branched Chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg). one packet at 6pm and two at 9pm.
Group II: PlaceboPlacebo Group1 Intervention
Equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Branched chain amino acid
2019
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Dayanand Medical College and HospitalLead Sponsor
7 Previous Clinical Trials
1,847 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
200 Patients Enrolled for Liver Cirrhosis
Sandeep s Sidhu, DMPrincipal InvestigatorDayanand Medical College and Hospital, Ludhiana, Punjab, India
~13 spots leftby Jan 2026