Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700, Thailand
NCT Number: NCT05724485
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 patients * Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients * Compared 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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bangkok Noi, Bangkok, 10700, Thailand
Cirrhosis is a late-stage of fibrosis of the liver caused by many forms of liver disease. Muscle cramps are visible or palpable involuntary contraction part of the muscle. The prevalence of cramps in cirrhosis varied range from 31-78%. The pathophysiology of cramps in cirrhosis was explained by multiple mechanisms such as energy metabolism, nerve function, and plasma volume. Cramps significantly diminished the quality of life in cirrhotic patients.
Many drugs, vitamins, and minerals were studied for treating cramps in cirrhosis in previous studies but no clinical improvement, good randomized control studies, or side effects.
Branched-chain amino acids (BCAA) had been developed to correct this amino acid imbalance and helped to decrease the frequency of cramps and improve the quality of life in cirrhotic patients from previous studies but there were no control groups and a small number of patients were included. The aim of this study was to evaluate the efficacy and safety of BCAA for controlling muscle cramps in cirrhotic patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12.45 grams of BCAA orally per day before bedtime
12.45 grams of Maltodextrin orally per day before bedtime
Other names: Maltodextrin
Time frame: 12 weeks
Change from baseline in muscle cramp frequency by patient's diary record
Time frame: 12 weeks
Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events
Time frame: 12 weeks
Change from baseline in muscle cramp severity by patient's diary record as the visual analog scale that reported from 0 (no pain) to 10 (worst pain).
Time frame: 12 weeks
Change of quality of life in cirrhotic patients with muscle cramps at the end of the study compared to baseline by chronic liver disease questionnaire (CLDQ) that includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and worry. The response of CLDQ results in 1 to 7 scales: ranging from "all of the time" to "none of the time".
Time frame: 12 weeks
Change of muscle mass in cirrhotic patients with muscle cramps at the end of the study compared to baseline by bioelectrical impedance analysis (BIA)
Time frame: 12 weeks
Change of muscle strength in cirrhotic patients with muscle cramps at the end of the study compared to baseline by hand grip strength measurement
Time frame: 12 weeks
Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline
Time frame: 12 weeks
Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
Time frame: 12 weeks
Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
Mahidol University
Other
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