Protocol summary
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Study aim
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The aim of this study is evaluation of effect of Curcumin on non- alcoholic fatty liver disease treatment and the serum levels of inflammatory cytokines and highly sensitive C-reactive protein (hsCRP) in the patients with non- alcoholic fatty liver (NAFLD).
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Design
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This study is an 2-months, concealed, randomized, double-blind, placebo-controlled, parallel-group conduct in Neyshabur city in the north east of Iran. The allocation ratio is 1:1 for three groups. The study groups contains two intervention groups of Curcumin with dose of 250 mg/day and 500 mg/day and Placebo group whose receives lactose with dose of 250 mg/day. Sample size of each groups is 40 patients.
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Settings and conduct
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In order to the random allocation sequence, the entire randomization process is concealed. For this purpose, the drugs are already put in envelopes labeled a serial number from 1 to 120. No one know the nature of the envelopes except the coordinator of the trial.
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Participants/Inclusion and exclusion criteria
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Referred patients of the 22 Bahman Hospital (Neyshabur, Iran) is recruited. The inclusion criteria is as follow: age between 18–65 years and the diagnosis of fatty liver using ultrasound and the exclusion criteria were women with pregnancy/lactation, taking anti-inflammatory drugs such as Curtin and liver enzyme enhancement drugs, acute or chronic liver disorders such as viral (hepatitis B and C) and autoimmune hepatitis, hyper/hypothyroidism, alpha-1 antitrypsin deficiency, celiac disease and cancer.
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Intervention groups
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Intervention groups consists of two groups. One group patients receives capsules of phospholipidated Curcumin (Meriva curcumin phytosome) with a dose of 250 mg/day after dinner and other group receives Curcumin C3 complexTM (500 mg) plus BioperineTM.
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Main outcome variables
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NAFLD grade, liver function tests including AST, ALT and ALP, MCP-1, IL-10, IL-6, TNF- alpha and hsCRP
General information
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Reason for update
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Errors and mistakes during submissions of the protocol by the user and minor and possible protocol changes during project execution
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015052322381N1
Registration date:
2016-09-17, 1395/06/27
Registration timing:
prospective
Last update:
2019-10-22, 1398/07/30
Update count:
1
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Registration date
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2016-09-17, 1395/06/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Neyshabur University of Medical Sciences (research grants)
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Expected recruitment start date
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2016-08-22, 1395/06/01
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Expected recruitment end date
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2017-03-21, 1396/01/01
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Actual recruitment start date
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2017-01-23, 1395/11/04
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Actual recruitment end date
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2017-08-30, 1396/06/08
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Trial completion date
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2017-11-07, 1396/08/16
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Scientific title
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Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein level in the patients with Non-alcoholic fatty liver disease (A double-blind, randomized, placebo-controlled trial)
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Public title
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Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines & highly sensitive C-reactive protein
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 18–65 years
The diagnosis of fatty liver using ultrasound
Exclusion criteria:
Women with pregnancy/lactation
Alcoholic liver disease
Taking anti-inflammatory drugs such as Curtin
Acute or chronic liver disorders such as viral (hepatitis B and C) and autoimmune hepatitis
Metabolic liver disorders including hemochromatosis and Wilson’s disease, Budd–Chiari syndrome
Having other medical disorders such as cardiovascular diseases and cancer
Taking liver enzyme enhancement drugs
Have severe heart and lung disease
Hypothyroidism and hyperthyroidism
Alpha-1 antitrypsin deficiency
Celiac disease
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Age
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From 15 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
43
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Two letters were prepared and written on two sheets “A” for “curcumin” and “B” for “control.” AABB, ABAB, ABBA, BBAA, BABA, BAAB, all quad blocks were possible. Then the number was selected randomly via a table of random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To ensuring that implementation of the random allocation sequence occurs without the knowledge of which patient will receive which treatment, the entire randomization process was concealed. For this purpose, the drugs were already put in envelopes labeled a serial number from 1 to 80. No one knew the nature of the envelopes except the coordinator of the trial.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-02-20, 1394/12/01
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Ethics committee reference number
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IR.NUMS.REC.1394.18
Health conditions studied
1
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Description of health condition studied
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NAFLD
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ICD-10 code
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K75.8
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ICD-10 code description
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nonalcoholic steatohepatitis
Primary outcomes
1
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Description
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NAFLD grade
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Sonography
2
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Description
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Tumor necrosis factor alpha (TNF-α)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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ELISA
3
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Description
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High-sensitivity C-reactive Protein (hs-CRP)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto-analyzer BT-2000
4
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Description
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Interleukin 6 (IL-6)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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ELISA
5
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Description
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Interleukin 10 (IL-10)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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ELISA
6
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Description
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Monocyte Chemoattractant Protein-1 (MCP-1)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Aspartate Aminotransferase (AST)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
2
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Description
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Alanine Aminotransferase (ALT)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
3
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Description
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Alkaline Phosphatase (ALP)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
4
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Description
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Fasting blood sugar (FBS)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
5
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Description
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Triglyceride (TG)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
6
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Description
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Total cholesterol (TC)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
7
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Description
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High-density lipoprotein cholesterol (HDL-C)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
8
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Description
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Low-density lipoprotein cholesterol (HDL-C)
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Timepoint
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Before intervention and two months after intervention
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Method of measurement
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Auto Analyzer BT-2000
Intervention groups
1
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Description
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Curcumin Phytosome (Meriva) with dose 250 mg/day (phospholipidated curcumin, 250 mg equivalent to 50 mg curcumin)
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Category
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Treatment - Drugs
2
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Description
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Curcumin C3 complexTM (500 mg) plus BioperineTM (5 mg, patented extract obtained from black pepper fruits (Piper nigrum) standardized minimum to 95% Piperine.
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Category
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Treatment - Drugs
3
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Description
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Control group or Placebo consumes capsules lactose with similar shape and size of intervention groups and a dose of 250 mg/day. Drug consumption is as oral during a 2-month period.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Neyshabour University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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If the request is made by a researcher, the data will be shared according to the relevant criteria.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available