Effect of Nano-curcumin Supplementation in Acute Pancreatitis
Primary Purpose
Acute Pancreatitis
Status
Active
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Nano-curcumin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Patients with a clinical diagnosis of moderate acute pancreatitis (specifically, a history of acute abdominal pain associated with a greater than threefold elevation of the serum amylase and/or computed tomographic evidence of acute pancreatitis) presenting within 72 hours of onset of pain
- Age range of 18-75
- having the ability to intake soft gels orally
- lack of Pregnancy or breastfeeding
- lack of any history of allergy to Curcumin
- Patients with no acute exacerbation of chronic pancreatitis
- lack of prior antioxidant therapy
- lack of severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cl Cr <30))
- lack of active gastrointestinal ulcers
- not to take anticoagulants such as heparin, Clopidogrel, Dipyridamole, Warfarin and Ticlopidine
Exclusion Criteria:
- The patient's unwillingness to continue cooperating
- Patients who have not consumed more than 20% of soft gels
- The diagnosis of the treating physician based on the termination of the patient's participation in the study
- Incidence of side effects due to supplementation in the patient
Sites / Locations
- National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nano-curcumin
Placebo
Arm Description
80mg of Nano-curcumin daily
Placebo
Outcomes
Primary Outcome Measures
Hospital length of stay
calculated from the day of admission until the time of discharge from the hospital.
Secondary Outcome Measures
Overall appetite
patient's appetite based on visual analogue scale
Abdominal pain intensity
patient's pain intensity according to verbal numerical rating scale (0-10)
CRP
Serum level of C-reactive protein
Analgesic medications
daily doses of as-needed analgesics
Hospital readmission
Patient's readmission to the hospital after discharge
Full Information
NCT ID
NCT04989166
First Posted
July 31, 2021
Last Updated
December 5, 2022
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT04989166
Brief Title
Effect of Nano-curcumin Supplementation in Acute Pancreatitis
Official Title
Effect of Nano-curcumin Supplementation on Hospital Length of Stay, Clinical Outcomes,and Inflammation Level in Mild and Moderate Acute Pancreatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
January 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nano-curcumin
Arm Type
Active Comparator
Arm Description
80mg of Nano-curcumin daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Nano-curcumin
Intervention Description
Nano-curcumin soft gels
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
calculated from the day of admission until the time of discharge from the hospital.
Time Frame
through study completion, up to 2 weeks
Secondary Outcome Measure Information:
Title
Overall appetite
Description
patient's appetite based on visual analogue scale
Time Frame
days 0, 1, 2, 3, 4, and 14 of admission
Title
Abdominal pain intensity
Description
patient's pain intensity according to verbal numerical rating scale (0-10)
Time Frame
days 0, 1, 2, 3, 4, and 14 of admission
Title
CRP
Description
Serum level of C-reactive protein
Time Frame
days 0 and 14 of admission
Title
Analgesic medications
Description
daily doses of as-needed analgesics
Time Frame
days 0, 1, 2, 3, 4, and 14
Title
Hospital readmission
Description
Patient's readmission to the hospital after discharge
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Nano-curcumin Supplementation in Acute Pancreatitis
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