CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Branched-chain Amino Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05724485
NCT05724485Phase 4Completed

Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis

Mahidol University·interventional·Posted Feb 13, 2023·Updated Feb 9, 2024

In Brief

A Phase 4 clinical trial evaluating Branched-chain Amino Acid and Placebo for Muscle Cramp and 2 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedFeb 13, 2023
Enrollment StartApr 1, 2023
Primary CompletionOct 31, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.4 years ago

Interventions

Branched-chain Amino Aciddrug

12.45 grams of BCAA orally per day before bedtime

Placebodrug

12.45 grams of Maltodextrin orally per day before bedtime