The effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis.
To determine the effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis
Design
A randomized, double-blinded, controlled clinical trial with a parallel group design of 42 patients. Random number table will be used for randomization.
Settings and conduct
42 eligible patients with moderate acute pancreatitis will randomly assign to consume two soft gels daily each containing 40 mg of Nano-curcumin or placebo 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 CBC, kidney and liver function, blood sugar, electrolytes and 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. In this study participants and investigators will be blinded and concealment will be done by a third person.
Participants/Inclusion and exclusion criteria
People with a clinical diagnosis of moderate acute pancreatitis presenting within 72 hours of onset of pain and in the age range of 18-75 who are able to intake soft gels orally and desire to participate in the study will be included in the study. While people having pregnancy or breastfeeding, any history of allergy to Curcumin, acute exacerbation of chronic pancreatitis, prior antioxidant therapy, severe co-morbid illness, active gastrointestinal ulcers or those who take anticoagulants will be excluded from the study.
Intervention groups
1- Nano-curcumin group: receiving 80mg of Nano-curcumin daily in the form of 40mg soft gels for 14 days
2-Plasebo group: placebo soft gels containing MCT oil for 14 days
Main outcome variables
Length of hospital stay, Serum CRP level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N33
Registration date:2021-11-25, 1400/09/04
Registration timing:prospective
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis.
Public title
The effect of Nano-curcumin supplementation on clinical symptoms and signs, length of hospital stays and inflammation level in moderate acute pancreatitis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the National Institute of Nutritional Research and Food Industry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1400.057
Health conditions studied
1
Description of health condition studied
Moderate Acute Pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis
Primary outcomes
1
Description
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
2
Description
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)
Secondary outcomes
1
Description
Abdominal pain severity
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Visual analog scale (VAS)
2
Description
Serum ALT concentration
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
3
Description
Serum ALT concentration
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
4
Description
Serum ALK-P concentration
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
5
Description
Serum Creatinine concentration
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
6
Description
Blood Urea Nitrogen (BUN) concentration
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
7
Description
Serum Amylase level
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
8
Description
Serum Lipase level
Timepoint
At the beginning and the end of the study (14th day)
Method of measurement
Enzymatic method
Intervention groups
1
Description
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.
Category
Other
2
Description
Control group: Will take two placebo capsules daily, which are similar in shape and taste to Nanocurcumin soft gel, orally for two weeks.