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临床试验/NCT06328088
NCT06328088招募中不适用

Effect of Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis:An Open Label Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Recurrence of overt hepatic encephalopathy

研究概览

简要总结

Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study

详细描述

Hepatic encephalopathy (HE) is a neurological complication in cirrhosis and affects 30-80% of these patients. Patient conscious level varies from minimal altered sensorium to deep coma and hence it is classified into two categories, covert HE and overt HE. Its occurrence in patients with cirrhosis merits liver transplantation and it reduces survival rate to 50% in next 1-2 year. HE significantly affects quality of life, inability to drive, morbidity and mortality . Recovery from single episode of HE merits secondary prophylaxis with lactulose and rifaximin .

Protein calorie malnutrition is also common in patients with cirrhosis and its prevalence varies from 30-90% depending upon the method of evaluation and types of patients enrolled . Sarcopenia negatively affects survival and can be precipitated by repeated episodes of admission and HE in patients with cirrhosis. Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE . Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study . We wish to study effect of diet on the recurrence of HE in patient with cirrhosis who had recovered completely from an episode of HE and are on secondary prophylaxis of HE.

Materials and methods:

Consecutive patients with cirrhosis who have recovered from an episode of HE will be screened and enrolled in the study if fulfilling the enrolment criteria. Cirrhosis will be diagnosed based on clinical, radiological, Transient elastography and biopsy if available. All relevant investigation will be done to evaluate the cause of cirrhosis (Viral markers, autoimmune markers etc). HE will be diagnosed based on West Heaven criteria and recovery will be assessed by the senior Consultant of this study. All patient will undergo handgrip strength test to assess muscle strength, number connection test and critical flicker frequency test to assess minimal hepatic encephalopathy at baseline and at 1,3 and 6 month interval.

Handgrip test: This is a simple bed side test non-invasive tests in which patient will sit on a chair and held a instrument and press it as hard as possible after a training session to get the muscle strength. Its value will be recorded (26).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older. 2) Confirmed diagnosis of liver cirrhosis. (Diagnosed on the basis of clinical, biochemical, radiological or endoscopic features).
  • Willingness to sign informed consent proforma. 4) Patients who recovered from Hepatic encephalopathy will be enrolled from Out patient Department within 15 days of discharge

排除标准

  • Patients with underlying severe cardiopulmonary disease or hepatocellular carcinoma.
  • Patients with CTP score of more than 12 3) Patient not willing for follow up or consent to participate in the study

结局指标

主要结局

Recurrence of overt hepatic encephalopathy

时间窗: 6 month follow up

次要结局

  • Hospitalization due to any cause(six month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Praveen Shrama

Professor

Sir Ganga Ram Hospital

研究点 (1)

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