| CTRI Number |
CTRI/2010/091/000087 [Registered on: 04/02/2010] |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the efficacy and safety of Glutathione in patients with alcoholic and non-alcoholic fatty liver disease. |
Scientific Title of Study
Modification(s)
|
A Phase III, multicenter, open label, single treatment clinical study to evaluate the safety and efficacy of Glutathione 600mg Injection in patients with alcoholic and non-alcoholic fatty liver disease. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ECTS/09/001 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr M L Shukla |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
Shuklas Hospital,
M. G. Road
Not Applicable
N/A
394602
India |
| Phone |
02622220235 |
| Fax |
|
| Email |
drshukla99@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11. Devipark.
B/h Lake view Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11. Devipark.
B/h Lake view Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Lyka Labs Limited |
| Address |
R&D center, 216-219, Adarsh Industrial Estate, Andheri (E), Mumbai - 400093. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SV Deshpande |
Aashirwad Hospital |
Jijamata Udyan,Maratha section, Ulhasnagar-421001
Thane
MAHARASHTRA |
0222587006
svshrikant@gmail.com |
| Dr. Rajan Katale |
Sai Seva Hospital & Research Center |
Shri Hari Plaza, Near Adagaon Naka,Panchvati-422001
Nashik
MAHARASHTRA |
02532518201
rajankatale@rediffmail.com |
| Dr. Mayank Shah |
Shah heart & Medical hospital |
Nr. Kirti Stambh,-385001
|
02742 254107
drmayankmshah@rediffmail.com |
| Dr. Vijay Dhondge |
Shreeji Hospital |
Castle Rock,Canada Corner-422005
Nashik
MAHARASHTRA |
02532313775
02532313775
vijaydhondge66t@gmail.com |
| Dr. M. L. Shukla |
Shukla's Hospital |
M.G.Road,,Dist. Surat-394602
|
02622220235
drshukla99@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Mahesh L. Shukla |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Mayank Shah |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Rajan Katale |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. S. V. Deshpande |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Vijay Dhondge |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K700||Alcoholic fatty liver, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Glutathione |
600mg Injection upto 4 weeks |
| Intervention |
Glutathione |
a total of 1800mg diluted in 5% dextrose solution in divided dosage in case of IV injection for at least 2 weeks. |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Written informed consent from the patient.
2. Age above 18 years inclusive.
3. Diagnosis of Alcoholic liver disease (Changes in the liver as inflammation and lead to fatty liver as confirmed by Ultrasonography of liver and also based on 3-4 fold higher levels of SGOT and SGPT) clinically verified by a physician based on WHO criteria for alcohol abuse, dependence, and harmful use (tolerance, history of withdrawal syndrome, excessive use, unsuccessful control, use resulting in physical or psychological harm)
4. Patients with non-alcoholic fatty liver as confirmed by liver sonography
|
|
| ExclusionCriteria |
| Details |
? Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
? HIV positive individual.
? Hepatitis B & Hepatitis C positive individual
? Specific non-alcoholic liver disease
? Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
? Patients will be excluded who present with other chronic diseases that may affect liver function, such as cancer, congestive heart failure, renal insufficiency with serum creatinine greater than 1.4 mg/dl following rehydration, or infectious illness.
? Known hypersensitivity to Glutathione.
? Patient with any other gastrointestinal disorder.
? Patient who is consuming/ has received drugs, which have interaction with Glutathione, during last 14 days.
? Participation in any other clinical trial during last 30 days
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Liver Function parameters |
2-4 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Ultrasonography of liver |
up to 4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/02/2010 |
| Date of Study Completion (India) |
17/07/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open label, single treatment multicenter clinical trial evaluating safety and efficacy of Glutathione 600mg Injection in patients with alcoholic and non-alcoholic fatty liver disease that will be conducted at four centers in India. The primary outcome measures will be lowering of Liver function tests and improvement in liver ultrasonography during 4 weeks treatment. The secondory outcome will be evaluating safety aspects of the treatment. |