Effect of Nano-curcumin Supplementation in Acute Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Nano-curcumin Supplementation on Hospital Length of Stay, Clinical Outcomes,and Inflammation Level in Mild and Moderate Acute Pancreatitis.

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Dietary Supplement: Nano-curcumin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nano-curcumin<br>80mg of Nano-curcumin daily | Dietary Supplement: Nano-curcumin<br>* Nano-curcumin soft gels<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | calculated from the day of admission until the time of discharge from the hospital. | through study completion, up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall appetite | patient's appetite based on visual analogue scale | 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) | days 0, 1, 2, 3, 4, and 14 of admission | 
| CRP | Serum level of C-reactive protein | days 0 and 14 of admission | 
| Analgesic medications | daily doses of as-needed analgesics | days 0, 1, 2, 3, 4, and 14 | 
| Hospital readmission | Patient's readmission to the hospital after discharge | up to 90 days |