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Epidemiology study on Minimal Hepatic Encephalopathy

Minimal Hepatic Encephalopathy among Cirrhotics: A Cross Sectional, Clinico-Epidemiological, Multicentre, Nationwide Study: THE PREDICT STUDY - THE PREDICT STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/01/004306
Enrollment
1260
Registered
2014-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria

Interventions

None listed

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard, having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria. 2. Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of HRQOL. 3. Patients willing to provide written authorization to provide data for the study.

Exclusion criteria

Exclusion criteria: 1. History of recent alcohol intake ( 12 weeks)/substance abuse , or gastrointestinal bleeding ( 4 weeks), serious infection, use of drugs affecting psychometric performances ( 4 weeks). 2. Severe medical problems that could influence quality-of-life measurement 3. Inability to perform neuropsychometric tests and to complete the SF-36 questionnaire. 4. Patients with neuropsychiatric diseases like stroke, epilepsy, dementia, parkinsonism etc. 5. Hepatocellular carcinoma

Design outcomes

Primary

MeasureTime frame
Prevalence (%) of MHE among cirrhotic patientsTimepoint: Baseline (single visit)

Secondary

MeasureTime frame
Assessment of HRQOL in MHE patients using SF-36 questionnaireTimepoint: Baseline (single visit);Demographic characteristics of the patientsTimepoint: Baseline (single visit);Detailed history on smoking and past history of alcohol consumptionTimepoint: Baseline (single visit);Etiology and co-morbid conditions associated with cirrhosisTimepoint: Baseline (single visit);Laboratory and other investigations like radiology or endoscopy findings, if availableTimepoint: Baseline (single visit);Pattern of drug prescription after diagnosis of MHE in treatment of naïve and those on therapyTimepoint: Baseline (single visit);Pattern of drug prescription before diagnosis of MHE in treatment of naïve patients and those on therapyTimepoint: Baseline (single visit);Subgroup analysis using MMSE score, Child Pugh Score and MELDTimepoint: Baseline (single visit)

Countries

India

Contacts

Public ContactDr Ravi Shankar

Postgraduate Institute of Medical Education & Research

rkpsdhiman@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026