TO SEE THE EFFECT OF ANTIOXIDANTS(COMBINATION OF VITAMINS AND NUTRIENTS THAT PROTECT OUR CELLS) ON THE FUNCTIONS OF THE PANCREAS(ENDOCRINE AND EXOCRINE)IN PATIENTS WITH CHRONIC PANCREATITIS
- Conditions
- Health Condition 1: null- PATIENTS WITH CHRONIC PANCREATITIS
- Registration Number
- CTRI/2011/05/001755
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1.Patients with chronic pancreatitis willing to come at 3 monthly interval for 1 yr will be included in the study.
2.Patients with Chronic Pancreatitis with onset of symptom ie pain of less than equal to 3yrs for non diabetics and diabetics with any duration of disease.
1.Patients who have received in the preceding 3 months or taking at present antioxidants will be excluded.
2.Patients who have had an intervention earlier in the form of decompressive therapy i.e. surgery or endoscopic sphincterotomy/ stenting or lithotripsy for pancreatic calculi.
3.Patients with systemic conditions such as liver disease, chronic renal failure, malignancy, hypertension, and pregnancy that might affect the antioxidant status and oxidative stress levels will be excluded.
4.Patients with complications such as symptomatic pseudocyst, bile duct obstruction, pancreatic abscess and pancreatic cancer
5.Patients not giving consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome <br/ ><br>1.Improvement in beta cell function <br/ ><br>2.Improvement of exocrine function <br/ ><br>3.Improvement in markers of fibrosis <br/ ><br>Timepoint: 0,3,6 and 9 months
- Secondary Outcome Measures
Name Time Method 1.Reduction in pain and improvement in quality of life <br/ ><br>2.Change in inflammatory markers <br/ ><br>3.Improvement in nutritional status <br/ ><br>4.Increase in the markers of antioxidant defense and decrease in parameters of oxidative stress <br/ ><br>5.Change in the markers of oxidative stress and antioxidant status with and without continuation of supplementation <br/ ><br>Timepoint: 0,3,6 and 9 months