CTRI/2010/091/000125已完成2 期
Health related quality of life in patients with chronic liver disease and effect of probiotics in the treatment of MHE and health related quality of life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •All the patients with Chronic liver disease (CLD) aged between 15 to 80 years of both the genders would be enrolled consecutively. Selection criteria would be the following:
- •1.All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
- •2.Alcohol would be considered to be the cause of CLD, if the patient regularly consumed more than or equal to 80g/d of alcohol for five years
- •3.The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
- •4.The causes of CLD would be divided into:-
- •a.viral hepatitis
- •c.viral hepatitis combining with alcohol
- •d.miscellaneous causes
- •Part II: All the patients of both genders with MHE aged between 15 to 80 years of both the genders would be enrolled consecutively. Selection criteria would be the following:
- •1.All the consecutive patients with CLD without overt encephalopathy would be screened for MHE and then recruited
- •2.All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS
- •3.The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials
排除标准
- •1. Patients with overt hepatic encephalopathy
- •2. Active medical co-morbidities
- •3. Malignancy
- •4. Refused to participate in the study
- •1.Presence of overt HE
- •2.History of taking lactulose or probiotics or antibiotics, in the past 6 weeks.
- •3.Presence of other neurological or psychiatric disorder
- •4.Patients who underwent shunt surgery for portal hypertension
- •5.History of taking medicines likely to interfere with psychometric performance
- •6.History of alcohol intake during past 6 weeks
- •7.History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
- •8.Presence of significant co morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
- •9.Presence of mature cataracts and diabetic retinopathy.
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