| CTRI Number |
CTRI/2009/091/000876 [Registered on: 10/11/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A clinical trial to study the efficacy of steroids versus steroids and pentoxifylline in the treatment of patients with severe acute alcoholic hepatitis |
|
Scientific Title of Study
|
A randomized, controlled trial to study the efficacy of steroids versus steroids and pentoxifylline in severe acute alcoholic hepatitis |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1111-3581 |
UTN |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Sidhu |
| Designation |
|
| Affiliation |
|
| Address |
Department of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
0161- 2402855 |
| Fax |
0161-2302620 |
| Email |
dmcgastro@in.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Sidhu |
| Designation |
|
| Affiliation |
Professor |
| Address |
Department of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
0161- 2402855 |
| Fax |
0161-2302620 |
| Email |
dmcgastro@in.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Sidhu |
| Designation |
|
| Affiliation |
|
| Address |
Department of Gastroenterology
DMC and Hospital
Ludhiana
PUNJAB
141001
India |
| Phone |
0161- 2402855 |
| Fax |
0161-2302620 |
| Email |
dmcgastro@in.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Dr Sandeep Sidhu
Professor
Department of Gastroenterology
DMC and Hospital,
Ludhiana. Punjab
Tel: 0161- 2402855 Cell: 9814025085,
Fax: 0161-2302620
Email- dmcgastro@in.com
|
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Sidhu |
DMC and Hospital |
Department of Gastroenterology,DMC and Hospital-141001
Ludhiana
PUNJAB |
0161-4687315
0161-2302620
dmcgastro@in.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Severe alcoholic hepatitis (defined by modified Maddreys Discriminant Function ≥ 32), |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prednisolone |
40 mg pre day for 4 weeks |
| Intervention |
Prednisolone and Pentoxifylline |
Prednisolone 40 mg per day and Pentoxifylline 400 mg thrice a day for 4 weeks |
|
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Inclusion Criteria
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| Age From |
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| Age To |
|
| Gender |
|
| Details |
Patients of alcoholic hepatitis with modified Maddrey?s Discriminant factor (DF) ≥ 32
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| ExclusionCriteria |
| Details |
Improvement in DF with symptomatic treatment for 5-7 days
Positive viral serology for HAV, HBV, HCV or HEV
Concomitant bacterial or fungal infections
Active gastrointestinal haemorrhage
Severe cardiovascular or pulmonary diseases
Neoplastic and other inflammatory conditions
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Reduction in Mortality |
4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hepatic functions |
4 weeks |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized single centre trail evaluating the difference in the efficacy of a combination of corticosteroids (tab Prednisolone 40 mg/day) and pentoxifylline (400 mg, thrice a day, per oral) versus corticosteroids alone for reducing short term (28 days) mortality in patients with severe alcoholic hepatitis. The primary outcome measures will be reduction in short term mortality, while the secondary outcome measures would be improvement in hepatic function. |