Role of Antioxidants Supplementation in Chronic Pancreatitis
CompletedPhase 3NCT00319358
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic pancreatitis is a progressive inflammatory disease of the pancreas that presents with abdominal pain and in late stages may cause diabetes and malnutrition. The pain may be incapacitating and may affect patients physically, mentally and socially. Pain due to chronic pancreatitis is difficult to treat. Oxidative stress and free radical mediated injury has been shown to cause pancreatic inflammation. It has been shown that patients with chronic pancreatitis are deficient in micronutrients and natural antioxidants such as b-carotene, vitamin E and C etc. Studies have suggested that antioxidant supplementation may help to combat pain in these patients. Antioxidant supplementation may decrease the oxidative stress and boost the antioxidant status, thereby resulting in pain relief. The investigators have planned to perform a trial to study the effect of antioxidant supplementation on pain relief in patients with chronic pancreatitis.
Study details
- Official title
- Effect of Antioxidant Supplementation on Pain, Antioxidant Profile and Oxidative Stress in Patients With Chronic Pancreatitis
- Conditions
- Interventions
- Dietary supplement: Antioxidants
- Dietary supplement: Placebo
- Sponsor
- All India Institute of Medical Sciences
- Start date
- 2003-10
- Sex
- All
- Age range
- from 12 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- India
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * CP with significant pain i.e., at least one episode of pain in a month requiring oral analgesic or one episode of severe pain in last three months requiring hospitalization Exclusion Criteria: * Painless disease * Current pain more likely due to non-pancreatic origin * If the patient already has an intervention in the form decompressive therapy i.e., surgery or endoscopic sphincterotomy/ stenting or ESWL * Systemic conditions like CRF, malignancy, hypertension, and pregnancy * Complications like pseudocyst, pancreatic abscess * Patients who would have received antioxidants in the preceding 4 weeks * Narcotic addicts * Uncontrolled diabetes * Comorbid conditions like liver diseases
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00319358