Effect of Nano-curcumin Supplementation in Acute Pancreatitis

National Nutrition and Food Technology Institute42 enrolled

Overview

This study aims to investigate the effect of nano-curcumin supplementation on hospital length of stay, clinical outcomes, and inflammation level in mild and moderate acute pancreatitis. 42 eligible patients with mild and moderate acute pancreatitis will randomly assign to consume two soft gels each containing 40 mg of nano-curcumin or placebo (control group) every morning and evening for two weeks. Both groups will also receive the standard medical treatment of acute pancreatitis according to relevant guidelines. Patient's blood samples and clinical outcomes will assess on days 0, 1, 2, 3, 4, and 14 of admission. The two groups will also be compared in terms of adverse events and hospital length of stay. Moreover, the patient's hospital readmission due to pancreatitis will be recorded within 90 days of hospitalization.

The dietary intake of patients will be examined by two non-consecutive 24-hour food recalls at baseline and end of the study. The patient's weight (kg) and Body Mass Index (BMI) will also be measured.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Pancreatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of acute pancreatitis by at least two of the three following criteria: 1) a history of acute abdominal pain 2) greater than the threefold elevation of the serum amylase and/or lipase level 3) computed tomographic evidence of acute pancreatitis * Admission within 72 hours of onset of pain * Age range of 18-75 * Ability to intake soft gels orally Exclusion Criteria: * Severe or critical AP on admission * Pregnancy or lactation * A history of allergy to curcumin * Acute exacerbation of chronic pancreatitis * Prior antioxidant therapy * Severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cr Cl \< 30 ml/min)) * Active infection * Active malignancy * Hyperthyroidism * Persistent organ failure \> 48 hours (according to Marshall score) * On anticoagulant/ anti platelet medications

Outcomes

Primary Outcomes

Hospital length of stay

calculated from the day of admission until the time of discharge from the hospital.

Time frame: through study completion, up to 2 weeks

Secondary Outcomes

Overall appetite

patient's appetite based on visual analogue scale

Time frame: days 0, 1, 2, 3, 4, and 14 of admission

Abdominal pain intensity

patient's pain intensity according to verbal numerical rating scale (0-10)

Time frame: days 0, 1, 2, 3, 4, and 14 of admission

CRP

Serum level of C-reactive protein

Time frame: days 0 and 14 of admission

Analgesic medications

daily doses of as-needed analgesics

Time frame: days 0, 1, 2, 3, 4, and 14

Hospital readmission

Patient's readmission to the hospital after discharge

Time frame: up to 90 days