| CTRI Number |
CTRI/2011/05/001747 [Registered on: 19/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
18/05/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see the effect of antioxidants(vitamins and minerals that protect our cells) on scarring of the pancreas in patients with chronic pancreatitis |
|
Scientific Title of Study
|
Effect of antioxidant supplementation on progression of pancreatic fibrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop Saraya |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
R No 3068
Deptt of Gastroenterology
AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593294 |
| Fax |
011-26588641 |
| Email |
anoopgetrial@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop Saraya |
| Designation |
|
| Affiliation |
|
| Address |
Deptt of Gastroenterology
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593294 |
| Fax |
011-26588641 |
| Email |
anoopgetrial@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop Saraya |
| Designation |
|
| Affiliation |
|
| Address |
Deptt of Gastroenterology
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593294 |
| Fax |
011-26588641 |
| Email |
anoopgetrial@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
ANSARI NAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANOOP SARAYA |
AIIMS |
R No 3068
DEPTT OF GASTROENTEROLOGY
AIIMS
Ansari Nagar
ANSARI NAGAR
South
DELHI |
91-11-26593294
ansaraya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutes ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo capsules |
1 capsule BD for 3 months |
| Intervention |
The antioxidant supplementation will be given as capsules of betamoreG . The antioxidant supplementation will include daily doses of 600ug organic selenium,0.54g vit C, 9000 IU b-carotene,270 IU vit E and 2 g methionine . |
1 tablet BD for 3 months along with standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the treatment naïve patient with Chronic Pancreatitis |
|
| ExclusionCriteria |
| Details |
1. Complications like pseudocyst, pancreatic abscess, pseudoaneurysm, pancreatic fistula
2. Comorbid conditions like liver diseases,renal failure,pulmonary fibrosis.
3. Patient with adenocarcinoma of pancreas, acute on chronic pancreatitis.
4. Pregnant and lactating female
5. Age less than 12 years
6. Inability to give informed consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surrogate markers of pancreatic fibrosis: TGF-beta 1,PDGF, fibronectin and pro-collagen III |
at baseline and 3 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Markers of oxidative stress:
TBARS, Serum SOD
Marker of antioxidant capacity or defense:
Total glutathione, Ferric Reducing Assay of Plasma (FRAP)
|
at baseline and 3 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2010 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised control trial to see the effect of a combination of antioxidants for 3 months on markers of fibrosis in 80 patients of chronic pancreatitis.The primary outcome measures will be surrogate markers of fibrosis. The secondary outcome measures will be markers of oxidative stress and antioxidant levels. |