| CTRI Number |
CTRI/2011/05/001764 [Registered on: 27/05/2011] Trial Registered Prospectively |
| Last Modified On: |
27/05/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of RTFIT Tablets (Racemethionine 200 mg + Taurine 500 mg Tablets) in patients with alcoholic liver disease. |
|
Scientific Title of Study
|
A Randomized, Open Label, Parallel Group, Placebo-controlled, Efficacy and Safety Study of RTFIT Tablets in patients with alcoholic liver disease. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/10/012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHarishkumar Lalan |
| Designation |
Principle Investigator |
| Affiliation |
|
| Address |
Raptim Research Ltd.
A-226, M.I.D.C., T.T.C., Industrial Area,
Mahape, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
09820703576 |
| Fax |
|
| Email |
harishkumar.lalan@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHarishkumar Lalan |
| Designation |
Principle Investigator |
| Affiliation |
|
| Address |
Raptim Research Ltd.
A-226, M.I.D.C., T.T.C., Industrial Area,
Mahape, Navi Mumbai
MAHARASHTRA
400701
India |
| Phone |
09820703576 |
| Fax |
|
| Email |
harishkumar.lalan@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHarishkumar Lalan |
| Designation |
Principle Investigator |
| Affiliation |
|
| Address |
Raptim Research Ltd.
A-226, M.I.D.C., T.T.C., Industrial Area,
Mahape, Navi Mumbai
MAHARASHTRA
400701
India |
| Phone |
09820703576 |
| Fax |
|
| Email |
harishkumar.lalan@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| Zota Healthcare Ltd.
"ZOTA HOUSE", 2/896, Hira Modi Street,
Sagrampura, Surat-395 002
|
|
|
Primary Sponsor
|
| Name |
Zota Healthcare Ltd |
| Address |
"ZOTA HOUSE", 2/896, Hira Modi Street,
Sagrampura, Surat-395 002
|
| Type of Sponsor |
Contract research organization |
|
|
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 |
| Dr Milind Joshi |
Navjeevan Hospital |
Archana Jyotiâ€
1st Floor, Plot No. 18,
Sector-17, D.B.C. Vashi,
Navi Mumbai- 400 701
Thane
MAHARASHTRA |
27891801
mandarjoshi_83@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ettikka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Alcoholic liver disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination of Racemethionine and Taurine Tablets |
Patients will be administered either Fixed dose combination of Racemethionine 200 mg and Taurine 500 mg Tablets two times a day for a period of 5 weeks orally. |
| Comparator Agent |
Placebo Tablets |
Patients will be administered Placebo (B) two times a day for a period of 5 weeks Orally. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients of either sex between 20-60 years of age.
ii. Patients having history of alcoholic hepatitis, non alcoholic seatohepatitis (NASH), viral hepatitis (Jaundice), sclerosis of liver and drug induced hepatitis.
|
|
| ExclusionCriteria |
| Details |
i. Pregnancy or lactation
ii. Fasting glucose levels greater than 250 mg per deciliter
iii. Contraindication to liver biopsy
iv. Concomitant disease with reduced life expectancy
v. Hepatic failure
vi. Severe psychiatric conditions
vii. Drug dependence
viii. History of hemochromatosis, Wilson Disease, cholangitis, other chronic disease, renal insufficiency
ix. A known hypersensitivity to Taurine and Methionine or its structurally related compounds
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measures:
The efficacy will be evaluated by Liver Function Test (LFT)
|
at baseline, 7th day, 14th day, 21st day, 28th day, and 35th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome Measures:
Estimation of safety of RTFIT Tablets in patients with alcoholic liver disease based on Adverse Events
|
baseline, 7th day, 14th day, 21st day, 28th day, and 35th day. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
27/06/2011 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicabe |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Study is Randomized, Open Label, Parallel Group, Placebo-controlled, Efficacy and Safety Study of RTFIT Tablets in 200 patients with alcoholic liver disease that will be conducted in india.
Primary Outcome Measures:
The efficacy will be evaluated by Liver Function Test (LFT)
Secondary Outcome Measures:
Estimation of safety of RTFIT Tablets in patients with alcoholic liver disease based on Adverse Events |