Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 3:30 PM
Study NCT ID:
NCT04989166
Status:
UNKNOWN
Last Update Posted:
2022-12-07
First Post:
2021-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nano-curcumin Supplementation in Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'through study completion, up to 2 weeks', 'description': 'calculated from the day of admission until the time of discharge from the hospital.'}], 'secondaryOutcomes': [{'measure': 'Overall appetite', 'timeFrame': 'days 0, 1, 2, 3, 4, and 14 of admission', 'description': "patient's appetite based on visual analogue scale"}, {'measure': 'Abdominal pain intensity', 'timeFrame': 'days 0, 1, 2, 3, 4, and 14 of admission', 'description': "patient's pain intensity according to verbal numerical rating scale (0-10)"}, {'measure': 'CRP', 'timeFrame': 'days 0 and 14 of admission', 'description': 'Serum level of C-reactive protein'}, {'measure': 'Analgesic medications', 'timeFrame': 'days 0, 1, 2, 3, 4, and 14', 'description': 'daily doses of as-needed analgesics'}, {'measure': 'Hospital readmission', 'timeFrame': 'up to 90 days', 'description': "Patient's readmission to the hospital after discharge"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '37490939', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Admission within 72 hours of onset of pain\n* Age range of 18-75\n* Ability to intake soft gels orally\n\nExclusion Criteria:\n\n* Severe or critical AP on admission\n* Pregnancy or lactation\n* A history of allergy to curcumin\n* Acute exacerbation of chronic pancreatitis\n* Prior antioxidant therapy\n* Severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cr Cl \\< 30 ml/min))\n* Active infection\n* Active malignancy\n* Hyperthyroidism\n* Persistent organ failure \\> 48 hours (according to Marshall score)\n* On anticoagulant/ anti platelet medications'}, 'identificationModule': {'nctId': 'NCT04989166', 'briefTitle': 'Effect of Nano-curcumin Supplementation in Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'Effect of Nano-curcumin Supplementation on Hospital Length of Stay, Clinical Outcomes,and Inflammation Level in Mild and Moderate Acute Pancreatitis.', 'orgStudyIdInfo': {'id': '28664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nano-curcumin', 'description': '80mg of Nano-curcumin daily', 'interventionNames': ['Dietary Supplement: Nano-curcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nano-curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nano-curcumin soft gels', 'armGroupLabels': ['Nano-curcumin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'National Nutrition and Food Technology Research Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}