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

NCT05724485 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-09

No results posted yet for this study

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.

Conditions

  • Muscle Cramp
  • Cirrhosis
  • Quality of Life

Interventions

DRUG

Branched-chain Amino Acid

12.45 grams of BCAA orally per day before bedtime

DRUG

Placebo

12.45 grams of Maltodextrin orally per day before bedtime

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Siwaporn Chainuvati, Asso Prof · 66643249159

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-10-31
Completion
2023-12-31

Countries

  • Thailand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724485 on ClinicalTrials.gov