A Clinical trial to study the effect of steroids in patients with jaundice

Effect of short course Prednisolone therapy in the management of patients with acute viral hepatitis A with cholestasis - SAHA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002083

Enrollment

Registered

2011-10-21

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- ACUTE CHOLESTATIC VIRAL HEPATITIS A

Interventions

Intervention1: PREDNISOLONE 0.75 MG/kg/DAY TAPERED OVER 4 WEEKS VERSUS URSODEOXYCHOLIC ACID AT 20MG/KG FOR 4 WEEKS: PREDNISOLONE o.75 MG/kg/ PER DAY ORALLY ALONG WITH ANTIHISTAMINICS FOR 1 WEEK FOLLOW

Eligibility

Inclusion criteria

Inclusion criteria: PATIENTS WITH A DIAGNOSIS OF ACUTE VIRAL HEPATITIS A SERUM BILIRUBIN MORE THAN 10MG/DL SEVERE CHOLESTATIC SYMPTOMS GRADE 3 OR 4 PRURITIS

Exclusion criteria

Exclusion criteria: PATIENTS POSITIVE FOR HEPATITIS B AND C , PREGNANT AND LACTATING FEMALES , PATIENTS SUFFERING FROM MAJOR ILLNESS WILL BE EXCLUDED PATIENT WITH HISTORY OF HEAVY ALCOHOL MORE THAN 40MG/DAY IN THE RECENT PAST, THOSE SUFFERING FROM DIABETES , HYPERTENSION AND HAVING FEATURES OF LIVER FAILURE WILL BE EXCLUDED. PATIENTS WITH ATOPIC DERMATITIS, SCABIES AND PRURITIS DUE TO OTHER ETIOLOGIES WILL ALSO BE EXCLUDED

Design outcomes

Primary

Measure	Time frame
The purpose of this study is to asses the effect of short course steroid treatment in acute cholestatic viral hepatitis A,and whether steroid use is associated with improvement in cholestatic symptoms and pruritis .Timepoint: serial monitoring of clinical and laboratory parameters twice in the first 10 days and then weekly till 4 weeks and monthly for 6 months	—

Secondary

Measure	Time frame
SECONDARY OUTCOME IN THE FORM OF SIDE EFFECTS IF ANY WHEN USING SHORT TERM STEROIDS CAN BE OBSERVED.Timepoint: Study intend to asses clinical and laboratory improvement in patients at the end of 1st week, 2 nd week and 3 rd week.	—

Countries

India

Contacts

Public ContactDR JEFFEY GEORGE

Calicut Medical College

jeffeygeorge@gmail.com09496453848

Outcome results

None listed

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