Skip to content

Effect of antioxidant supplimentation on pain in recurrent acute pancreatitis

Role of anti-oxidants supplementation in recurrent acute pancreatitis: a randomized controlled trial - ARAP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007502
Enrollment
50
Registered
2016-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Recurrent Acute Pancreatitis

Interventions

Intervention1: Antioxidants: The antioxidant supplementation (cocktail of 5 antioxidants) will include daily doses of 600 microgram organic selenium, 0.54 g vitamin C, 9000 IU beta-carotene, 270 IU vi

Sponsors

ICMRapplying for funding
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with recurrent acute pancreatitis

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating mothers 2. Who are already on anti-oxidants in previous month 3. Patients with AP or CP or complications of it 4. Patients with co-morbid diseases such as liver disease, chronic renal failure, malignancy

Design outcomes

Primary

MeasureTime frame
The assessment of pain will be done in terms of total attacks of pancreatitis, requirement of oral and parenteral analgesics in the last six months and the need for hospitalisations in the previous 6 months. Pain score will be calculated with visual analogue scale (VAS).Timepoint: The assessment of pain will be done in terms of total attacks of pancreatitis, requirement of oral and parenteral analgesics in the last six months and the need for hospitalisations in the previous 6 months. Pain score will be calculated with visual analogue scale (VAS). Time Points: All the above parameters will be done at baseline, 3 months, 6months, 12 months and 18 months.

Secondary

MeasureTime frame
The markers of oxidative stress estimated in the present study will be malondialdehyde (MDA), 4-hydroxynonenal (4HNE) and serum Superoxide Dismutase (SOD). The markers of antioxidant status assessed will be glutathione peroxidase (Gpx), total antioxidant capacity (measured as ferric reducing ability of plasma- FRAP) and levels of Vitamin C. Fecal samples will be collected for analysis of Elastase (ELISA kit) and serum c-peptide, fasting/ PP glucose and insulin levels will be seen.Timepoint: Time Point: All the above parameters will be done at baseline, 3 months, 6 months, 12 months and 18 months.

Countries

India

Contacts

Public ContactAnoop Saraya

AIIMS, New Delhi

ansaraya@yahoo.com011-26593294

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026