N-Acetylcysteine Impact on Liver Enzymes in NAFLD Patients
Diet and exercise
+ NAC with diet and exercise
Enfermedades del Sistema Digestivo
+ Hígado Graso
+ Enfermedades del Hígado
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2022
Fecha en la que se inscribió al primer participante.Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects many people worldwide. It's characterized by fat build-up in the liver, which can lead to liver dysfunction. Currently, there's no approved treatment for NAFLD, and those with increased liver enzymes are at a higher risk of developing serious complications like cirrhosis and end-stage liver disease. This study aims to explore the potential benefits of a drug called N-acetyl cysteine (NAC) in improving liver function in NAFLD patients with raised liver enzymes (ALT and AST). The study focuses on adults with NAFLD, as confirmed by an ultrasound, and elevated liver enzymes. Participants in this study will be divided into two groups. The first group will follow a diet plan and engage in daily brisk walking for 20 minutes. The second group will receive NAC (200mg twice daily) in addition to following the same diet plan and exercise routine. The drug will be provided to the participants at no cost. Over 12 weeks, researchers will monitor liver function tests and any potential side effects of NAC. The primary goal is to evaluate if NAC can lead to a positive change in liver enzymes (ALT and AST) compared to diet and exercise alone.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 20 a 60 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * • Patients of both genders between the ages of 20 years and 60 years, giving consent to be included in the study. * Patients having fatty liver on ultrasound with raised ALT and AST levels Exclusion Criteria: * • Patients having other causes of steatosis eg, excessive alcohol consumption, * Patients taking steatogenic medications such as, methotrexate , corticosteroids etc. * Patients suffering from other diseases that could increase ALT levels eg. Viral hepatitis, HIV, autoimmune liver diseases, infiltrative liver diseases. * Patients suffering from malignancies. * Patients who are not compliant to the medicine. * Pregnant and nursing females
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios