Effect of Nano-curcumin Supplementation in Acute Pancreatitis

NCT04989166 | Unknown

• 1 other identifier: 28664
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall appetite

  days 0, 1, 2, 3, 4, and 14 of admission

• Abdominal pain intensity

  days 0, 1, 2, 3, 4, and 14 of admission

• CRP

  days 0 and 14 of admission

• Analgesic medications

  days 0, 1, 2, 3, 4, and 14

• Hospital readmission

  up to 90 days

Study Arms (2)

Nano-curcumin

ACTIVE COMPARATOR

80mg of Nano-curcumin daily

Dietary Supplement: Nano-curcumin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Nano-curcumin DIETARY_SUPPLEMENT

Nano-curcumin soft gels

Nano-curcumin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

Location

Related Publications (1)

• Chegini M, Sadeghi A, Zaeri F, Zamani M, Hekmatdoost A. Nano-curcumin supplementation in patients with mild and moderate acute pancreatitis: A randomized, placebo-controlled trial. Phytother Res. 2023 Nov;37(11):5279-5288. doi: 10.1002/ptr.7958. Epub 2023 Jul 25.

  PMID: 37490939 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 4, 2021
• Study Start: October 19, 2021
• Primary Completion: October 15, 2022
• Study Completion: January 15, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

IR (1)