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Improvement of Mood and Cognition in patients with chronic hepatitis C infection after specific treatment for HCV.

Effects of Direct acting antiviral agents on Cognitive Function and Depression in HCV related Cirrhosis: A Prospective Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018385
Enrollment
350
Registered
2019-04-02
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: K739- Chronic hepatitis, unspecified

Interventions

Intervention1: Direct-acting antiviral agents: Sofosbuvir Daclatasvir Ledipasvir Velpatasvir Control Intervention1: NIL: This is a single arm trial

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor
No secondary Sponsor
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients with viremic chronic hepatitis C Compensated Cirrhosis

Exclusion criteria

Exclusion criteria: Current overt hepatic encephalopathy or during the last 1 month, TIPS (transjugular intra-hepatic porto-systemic shunt), elective surgery planned within the next 8 weeks, unable to give informed consent, HIV, chronic respiratory insufficiency, renal failure (serum creatinine >= 2.0 mg/l, hepatocellular carcinoma, patient with other neurological disease and intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents. Pregnant Patients Pediatric Patients

Design outcomes

Primary

MeasureTime frame
Cognitive performance by (1) Computerized battery: Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test and (2) Paper-and-pencil tests: Psychometric hepatic encephalopathy score (PHES), Indian Version. HRQOL by SF-36 Timepoint: Time Frame: 0 days, and 90 days after treatment completion—

Secondary

MeasureTime frame
Beckâ??s Depression Inventory (BDI)Timepoint: Time Frame: 0 days, and 90 days after treatment completion;Generalized anxiety disorder (GAD 7 score)Timepoint: Time Frame: 0 days, and 90 days after treatment completion;Montreal Cognitive assessment Score (MoCA Score)Timepoint: Time Frame: 0 days, and 90 days after treatment completion;Psychometric hepatic encephalopathy Score (PHES)Timepoint: Time Frame: 0 days, and 90 days after treatment completion—

Countries

India

Contacts

Public ContactMadhumita Premkumnar

Postgraduate Institute of Medical Education and Research

drmadhumitap@gmail.com7087003409

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026