The Effect of Nano-curcumin Supplementation in Acute Pancreatitis

Sponsor
National Nutrition and Food Technology Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04989166
Collaborator
(none)
42
1
2
6
6.9

Study Details

Study Description

Brief Summary

This study aimed to investigate the effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stay and inflammation level in moderate acute pancreatitis. 42 eligible patients with 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 in hospital. Patients' blood samples will be taken before and after the intervention to determine complete blood count (CBC), kidney and liver function, blood sugar, electrolytes and C-reactive protein (CRP). Clinical signs during the hospitalization period will be recorded and the two groups will also be compared in terms of local complications and length of hospital stay.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nano-curcumin
  • Drug: Placebo
N/A

Detailed Description

Dietary intake of patients will be examined by two non-consecutive 24-hour food recalls at the beginning and end of the study. Patient's weight (kg) and Body Mass Index (BMI) will also be measured.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Nano-curcumin Supplementation on Clinical Symptoms and Signs, Length of Hospital Stays and Inflammation Level in Moderate Acute Pancreatitis.
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nano-curcumin

80mg of Nano-curcumin daily

Dietary Supplement: Nano-curcumin
Nano-curcumin soft gels

Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Length of hospital stay [through study completion, an average of 2 weeks]

    Admission days in hospital

  2. Serum CRP level [2 weeks]

    serum C-reactive protein level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Nutrition and Food Technology Research Institute Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Azita Hekmatdoost, Professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT04989166
Other Study ID Numbers:
  • 28664
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2021