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NCT05724485
Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis
Conditions: Muscle Cramp, Cirrhosis, Quality of Life
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 50
Sponsor: Mahidol University
Summary
The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients.
The main questions it aims to answer are:Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patientsCompared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patientsCompared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsMuscle cramp ≥ 1 time per weekConfirmed cirrhotic status (radiologic finding compatible with cirrhosis or liver stiffness measurement ≥ 12.5 kPa by transient elastography method or pathological confirm of cirrhosis)Exclusion Criteria:Allergy to BCAAOvert hepatic encephalopathyHepatorenal syndromeSevere renal insufficiency; eGFR < 30Heart failurePeripheral arterial diseaseActive malignancies beyond hepatocellular carcinomaHeavy alcohol drinking (> 21g/day for men and >14g/day for women)Pregnancy or lactationCurrent use of BCAA within 3 monthsRecent adding or titrating diuretics within 4 weeksOn current medications for muscle cramp relief such as vitamin E, taurine, carnitine, narcotic pain medications, baclofen, methocarbamol, other muscle relaxers, NSAIDs, or other antispastic agents.
Source: ClinicalTrials.gov (NCT05724485). StuddyBuddy aggregates publicly available trial information.