Acute Pancreatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNano-curcumin
Nano-curcumin soft gels
DRUGPlacebo
Placebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | through study completion, up to 2 weeks | calculated from the day of admission until the time of discharge from the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall appetite | days 0, 1, 2, 3, 4, and 14 of admission | patient's appetite based on visual analogue scale |
| Abdominal pain intensity | days 0, 1, 2, 3, 4, and 14 of admission | patient's pain intensity according to verbal numerical rating scale (0-10) |
| CRP | days 0 and 14 of admission | Serum level of C-reactive protein |
| Analgesic medications | days 0, 1, 2, 3, 4, and 14 | daily doses of as-needed analgesics |
| Hospital readmission | up to 90 days | Patient's readmission to the hospital after discharge |
Countries
Iran
Outcome results
None listed