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IRCT20100524004010N33 IRCT 2021-11-25 Shahid Beheshti University of Medical Sciences The effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis. The effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis. 2021-12-31 anticipated 42 Complete https://irct.ir/trial/59714 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomized into Nano-curcumin group or placebo according to the table of random numbers at the beginning of the study, Blinding description: Patients won’t know if they are receiving the Nano-curcumin or a placebo soft gel and for double-blinding the study, the bottles containing the relevant soft gels will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of soft gels received by each group. 2-3 Moderate Acute Pancreatitis. Intervention 1: Intervention group: Will take 80 mg of Nano-curcumin daily in the form of two soft gels each contains 40 mg of Nano-curcumin (Product of Exir Nano Sina Company) orally for two weeks. Intervention 2: Control group: Will take two placebo capsules daily, which are similar in shape and taste to Nanocurcumin soft gel, orally for two weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided how to share the final data.
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having desire to participate in the study Age range of 18-75 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. Having the ability to intake soft gels orally 18 years 75 years Both Pregnancy or breastfeeding History of allergy to Curcumin Acute exacerbation of chronic pancreatitis Taking antioxidant supplements such as vitamin C, vitamin E or omega 3 Severe co-morbid illness (liver disease including Cirrhosis and Hepatitis, renal failure (Cl Cr <30)) Active gastrointestinal ulcers Taking anticoagulants such as Heparin, Clopidogrel, Dipyridamole, Warfarin and Ticlopidine K85 Acute pancreatitis Other Placebo Intervention group: Will take 80 mg of Nano-curcumin daily in the form of two soft gels each contains 40 mg of Nano-curcumin (Product of Exir Nano Sina Company) orally for two weeks. Control group: Will take two placebo capsules daily, which are similar in shape and taste to Nanocurcumin soft gel, orally for two weeks. Length of hospital stay. Timepoint: Through study completion, an average of two weeks. Method of measurement: Counting the number of admission days in hospital based on medical records. Serum C-reactive protein level. Timepoint: At the first and the end of the 2nd week of the study. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Abdominal pain severity. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Visual analog scale (VAS). Serum ALT concentration. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Serum ALT concentration. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Serum ALK-P concentration. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Serum Creatinine concentration. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Blood Urea Nitrogen (BUN) concentration. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Serum Amylase level. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Serum Lipase level. Timepoint: At the beginning and the end of the study (14th day). Method of measurement: Enzymatic method. Shahid Beheshti University of Medical Sciences Approved 2021-10-20 Ethics Committee of the National Institute of Nutritional Research and Food Industry No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)