A Phase 4 interventional study of Branched-chain Amino Acid and Placebo in Muscle Cramp, Cirrhosis and Quality of Life, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
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:
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.
65 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 59 interventional studies indexed under Muscle Cramp.
Browse Muscle Cramp studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.
Drug: Branched-chain Amino Acid
12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.
Drug: Placebo
12.45 grams of BCAA orally per day before bedtime
12.45 grams of Maltodextrin orally per day before bedtime
Also known as: Maltodextrin
Change of muscle cramp frequency
Change from baseline in muscle cramp frequency by patient's diary record
Time frame: 12 weeks
Change of muscle cramp duration
Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events
Time frame: 12 weeks
Change of muscle cramp severity
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
Quality of life in cirrhotic patients with muscle cramps
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
Muscle mass in cirrhotic patients with muscle cramps
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
Muscle strengthening in cirrhotic patients with muscle cramps
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
Serum albumin
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
Serum alanine aminotransferase
Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
Time frame: 12 weeks
Serum aspartate aminotransferase
Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
Time frame: 12 weeks
Plan to share: Undecided
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amino Acids, Branched-Chain