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

Not Applicable

Recruiting

• Conditions: Patients of chronic pancreatitis

• Registration Number: CTRI/2011/05/001747
• Lead Sponsor: AIIMS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-03
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All the treatment naïve patient with Chronic Pancreatitis.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surrogate markers of pancreatic fibrosis: TGF-beta 1,PDGF, fibronectin and pro-collagen III	at baseline and 3 months of intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AIIMS; 🇮🇳 South, DELHI, India

AIIMS

🇮🇳South, DELHI, India

DR ANOOP SARAYA

Principal investigator

11-26593294

ansaraya@yahoo.com