Effect of Nano-curcumin Supplementation in Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2023-01-15

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.

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nano-curcumin

80mg of Nano-curcumin daily

Group Type ACTIVE_COMPARATOR

Nano-curcumin

Intervention Type DIETARY_SUPPLEMENT

Nano-curcumin soft gels

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Nano-curcumin

Nano-curcumin soft gels

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No