| CTRI Number |
CTRI/2024/06/069359 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of high dose steroids and compare it with no steroids in patients with severe alcoholic hepatitis with is a type of alcohol associated liver disease |
|
Scientific Title of Study
|
Evaluation of pulse dose corticosteroids in patients with severe alcoholic hepatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachis Ashdhir |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Attached hospitals |
| Address |
Department of Gastroenterology, SMS Superspeciality Hospital, Vivekanand Marg, Ashok Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302007
India |
| Phone |
9829966420 |
| Fax |
|
| Email |
pa894@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun S Sankannavar |
| Designation |
Senior Resident |
| Affiliation |
SMS Medical college and Attached Hospitals, Jaipur |
| Address |
Department of Gastroenterology, SMS Superspeciality Hospital, Vivekanand Marg, Ashok Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302007
India |
| Phone |
9481853997 |
| Fax |
|
| Email |
arun.ssankannavar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun S Sankannavar |
| Designation |
Senior Resident |
| Affiliation |
SMS Medical college and Attached Hospitals, Jaipur |
| Address |
Department of Gastroenterology, SMS Superspeciality Hospital, Vivekanand Marg, Ashok Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302007
India |
| Phone |
9481853997 |
| Fax |
|
| Email |
arun.ssankannavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prachis Ashdhir
Professor, Department of Gastroenterology, SMS Superspeciality Hospital, Vivekanand Marg, Ashok Nagar, Jaipur, Rajasthan, India- 302007 |
|
|
Primary Sponsor
|
| Name |
Dr Prachis Ashdhir |
| Address |
Department of Gastroenterology, SMS Superspeciality Hospital, Vivekanand Marg, Ashok Nagar, Jaipur, Rajasthan- 302007 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arun S Sankannavar |
SMS Superspeciality Hospital |
Department of Gastroenterology, 2nd floor, Room no 212, Vivekanand Marg, Panch Batti, Ashok Nagar
Jaipur
RAJASTHAN |
9481853997
arun.ssankannavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K701||Alcoholic hepatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulse dose Methylprednisolone |
Patients assigned to the pulse dose steroids group will receive 500mg Methylprednisolone on day 1, day 3 and day 15 along with the standard of care. Lillee score is assessed at day 4 and patient assessed for infections at day 15. Methyprednisolone given on day 15 if Lillee score was less than 0.45 and there is no evidence of infections at day 15. |
| Comparator Agent |
Standard of care group |
Patients assigned to the standard of care arm will receive Nutritional support, Tab UDCA, Tab Pentoxyfylline for 28 days along with supportive treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patients greater than 18years of age with diagnosed Severe Alcoholic hepatitis with mDF (Maddrey’s Discriminant function) greater than 32 with or without underlying cirrhosis are included. |
|
| ExclusionCriteria |
| Details |
Patients with evidence of active GI bleed,active Infections/ Sepsis,patients with mDF greater than 90,patients with encephalopathy,patients with AKI/ Renal failure,patients requiring inotropic support,not willing to give consent.presence of other liver diseases and pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify and compare the survival of patients on standard of care treatment and pulse dose steroids. |
The patients and the outcomes will be assessed at 4th day, at 2 weeks, at 4 weeks and at 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the appropriate dose and side effects profile of patients on pulse dose steroids. |
6weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regular dose steroids have been proven to be useful in the treatment of patients with severe alcoholic hepatitis but are associated with adverse effects including infections . Pulse dose steroids have been proven useful in various rheumatological, dermatological diseases and acute transplant rejections with equally good efficacy as regular daily dose steroids and lesser side effects. In this trial we intend to study the efficacy and side effects of pulse dose methylprednisolone in patients with severe alcoholic hepatitis.Patients diagnosed with severe alcoholic hepatitis are assessed for eligibility and given 3 doses of pulse dose methylprednisolone and followed up for 6 weeks. At the end of 6weeks the mortality rated and side effect profile are assessed. |