Effect of Nano-curcumin Supplementation in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04989166
• Other study ID #: 28664
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: December 2022
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: January 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Dietary Supplement:
• Nano-curcumin
Nano-curcumin soft gels

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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