Effect of Nano-curcumin Supplementation in Acute Pancreatitis

National Nutrition and Food Technology Institute

Status: Active, not recruiting

Conditions: Acute Pancreatitis

Treatments: Dietary Supplement: Nano-curcumin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04989166

28664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Nano-curcumin

Active Comparator group

Description:

80mg of Nano-curcumin daily

Treatment:

Dietary Supplement: Nano-curcumin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo