Quality of Life Clinical Trial
Official title:
Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis
Verified date | February 2024 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Muscle cramp = 1 time per week - Confirmed 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 BCAA - Overt hepatic encephalopathy - Hepatorenal syndrome - Severe renal insufficiency; eGFR < 30 - Heart failure - Peripheral arterial disease - Active malignancies beyond hepatocellular carcinoma - Heavy alcohol drinking (> 21g/day for men and >14g/day for women) - Pregnancy or lactation - Current use of BCAA within 3 months - Recent adding or titrating diuretics within 4 weeks - On 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. |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of muscle cramp frequency | Change from baseline in muscle cramp frequency by patient's diary record | 12 weeks | |
Secondary | Change of muscle cramp duration | Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events | 12 weeks | |
Secondary | 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). | 12 weeks | |
Secondary | 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". | 12 weeks | |
Secondary | 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) | 12 weeks | |
Secondary | 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 | 12 weeks | |
Secondary | Serum albumin | Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline | 12 weeks | |
Secondary | Serum alanine aminotransferase | Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline | 12 weeks | |
Secondary | Serum aspartate aminotransferase | Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline | 12 weeks |
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