| CTRI Number |
CTRI/2010/091/001170 [Registered on: 16/09/2010] |
| Last Modified On: |
02/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study of effect of glutathione rich diet in type-2 diabates. |
|
Scientific Title of Study
|
Study of effect of glutathione rich diet in on glucose metabolism and insulin kinetics in type-2 diabetes mellitus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs.Sethu |
| Designation |
|
| Affiliation |
|
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
sethuvnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs.Sethu |
| Designation |
|
| Affiliation |
Dietiatian |
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
sethuvnair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs.Sethu |
| Designation |
|
| Affiliation |
|
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
sethuvnair@gmail.com |
|
|
Source of Monetary or Material Support
|
| INYS-medical research society.Bangalore.Karnataka. |
|
Primary Sponsor
Modification(s)
|
| Name |
INYSmedical research societyBangaloreKarnataka |
| Address |
Jindal Nagar Tumkur Road Bangalore |
| Type of Sponsor |
Research institution |
|
|
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.Avinash Kadam |
INYS-Medical Research Society |
INYS-Medical Research Society,Jindal nagar.Tumkur Roda-560073
Bangalore
KARNATAKA |
080-23717777
080-23717785
dravinashkadam@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INYS-MRS,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
diabates mellitus , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
glutathione rich diet -mainly tomatoes |
300 mg and 600 mg of glutathione through salads containing mainly raw tomatoes ,daily for 15 days along with standard naturopathy and yoga treatment. |
| Comparator Agent |
standard naturopathy and yoga treatment |
naturopathy and yoga treatment without glutathione rich supplementation (salads)for 15 days. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Patients with Type 2 DM. |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled DM
2.Those patients who are taking metformin and/or parental insulin therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FBG -fasting blood glucose PBG -post prandial blood sugar ,serum fasting insulin |
Before starting the therapy, End of 1st and 2nd weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fasting serum insulin |
before starting the therapy, end 2nd week. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2010 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
|