Effect of Nano-curcumin Supplementation in Acute Pancreatitis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Nano-curcumin

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: Nano-curcumin; 80mg of Nano-curcumin daily	Dietary supplement: Nano-curcumin; Nano-curcumin soft gels

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Anticipated): January 15, 2023

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 28664

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No