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Role of Pharmacogenetics in patients with alcoholic hepatitis

Influence of Pharmacogenetic on prednisolone based therapy for patients with alcoholic hepatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032724
Enrollment
300
Registered
2021-04-12
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: K701- Alcoholic hepatitis

Interventions

Intervention1: Prednisolone: oral route,Dose 40mg, twice a day for 28 days. Control Intervention1: Nill: Nill

Sponsors

SRM Medical College Hospital and Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Presentation with clinically diagnosed alcoholic hepatitis. 2. Maddreyâ??s discriminate function >32 (Used in corticosteroid therapy & identifying the Risk factors) 3. Lille score >0.45 ( Identification of responding to corticosteroid therapy after 1 week) 4. MELD Score ( Model of end stage live disease) >18 indicates SAH

Exclusion criteria

Exclusion criteria: Multi-organ Dysfunction,Uncontrolled infection,Patients with a serum creatine >500µmol/L or requiring renal support,Hepatocellular carcinoma,Pregnancy.

Design outcomes

Primary

MeasureTime frame
To determine the overall response rate (complete response +partial response) to Pharmacogenetic based prednisolone therapy in patients with previously untreated alcoholic hepatitis.Timepoint: first response rate can be measured at 1st week from the day of the therapy for 4 weeks

Secondary

MeasureTime frame
To access the ADR in Alcoholic Hepatitis PatientsTimepoint: from 1st week to 4 th week measurment of ADRs were monitored.

Countries

India

Contacts

Public ContactDr T M Vijayakumar

SRM Medical College Hospital and Research Center

rajesha@srmist.edu.in9629006644

Outcome results

None listed

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