Protocol summary
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Study aim
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The effects of nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. Blocked randomization will be used for randomization.
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Settings and conduct
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50 patients will be selected among referring to Gastroenterology and endocrinology Clinic. At the beginning and end of the study (end of week 16), 14 ml of fasting blood samples will be taken. In this way, the appearance of the capsules will be the same and their packaging will be the same. Coding (A and B) will be done by someone outside the study. The given codes will be provided to the researchers after the statistical analysis of the data and when writing the article. At the beginning of the study and at the end of the fourth month, the liver fibrosis and steatosis will be determined by fibroscan, anthropometric factors including weight, height, waist circumference, body composition,and inflammatory, metabolic factors and blood pressure will be measured for all patients. Also, 3-day food recall questionnaire, physical activity questionnaire, and demographic information will be completed from the patients.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
patients between 30 and 70 years of age with liver fibrosis F≥2
exclusion criteria:
Alcohol addiction
Suffering from other chronic and acute liver disorders
Pregnancy or breastfeeding
current Lung and kidney disease and history of cancer
Drug abuse
Treatment with anti-inflammatory, hepatotoxic, corticosteroids and hormones medications
Use of weight loss medication or diets
current warfarin medications
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Intervention groups
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1 capsule of 40 mg of nanocurcumin or 1 capsule of identical-looking placebo two times daily.
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Main outcome variables
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liver fibrosis and steatosis
General information
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Reason for update
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The aforementioned clinical trial was registered in the april of 2023 and patient recruitment began thereafter. Patient recruitment for this clinical trial is still ongoing in August 2024. Unfortunately, due to an unintentional error during registration with the IRCT, the expected completion date was mistakenly entered The same as the start date. Consequently, the aforementioned clinical trial was erroneously registered as a retrospective and terminated study, even though it is still ongoing.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210427051098N2
Registration date:
2023-04-20, 1402/01/31
Registration timing:
registered_while_recruiting
Last update:
2024-08-13, 1403/05/23
Update count:
1
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Registration date
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2023-04-20, 1402/01/31
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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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Expected recruitment start date
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2023-04-20, 1402/01/31
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Expected recruitment end date
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2024-12-20, 1403/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effects of Nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin
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Public title
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The effect of Nanocurcumin on liver fibrosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients between 30 and 70 years of age with liver fibrosis F≥2 referring to the liver and digestive consultation and treatment clinic
Exclusion criteria:
History of alcohol intake or current intake of alcohol
evidence of other forms of chronic and acute liver diseases (such as viral hepatitis B, C etc), biliary disease, known autoimmune hepatitis and hereditary disorders affecting the liver (storage disease of iron, copper etc)
current pregnancy or breastfeeding
Use of hepatotoxic medication
current Lung and kidney disease
Drug abuse, history of cancer
Treatment with anti-inflammatory, corticosteroids and hormones medication
Use of weight loss medication or diets
Intolerance or allergy to the supplement
Unwillingness to participate in the study
New diet
Changes in the patient's medications
Patients with current warfarin medications
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Age
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From 30 years old to 70 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
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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50 patients with liver fibrosis, who have inclusion criteria and do not have exclusion criteria, based on a pre-designed random list (the list will be designed through the website https://www.sealedenvelope.com/simple-randomiser/v1/lists) ) will be randomly assigned to two groups to receive curcumin or placebo. Each drug package is assigned a code, the codes will be A and B.
To reduce the bias in placing people in the treatment or placebo groups, patients will be randomly assigned to one of the two nanocurcumin or placebo groups using the blocked randomization method (the size of the blocks is 4).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, blinding will be done in the type of supplement or placebo for researchers and patients. In this way, the appearance of the capsules will be the same and their packaging will be the same. Coding (codes will be A and B) will be done by someone outside the study.
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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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2023-01-29, 1401/11/09
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Ethics committee reference number
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IR.SSU.SPH.REC.1401.157
Health conditions studied
1
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Description of health condition studied
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Liver fibrosis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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liver fibrosis
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Timepoint
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Before and 16 weekes after the intervention
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Method of measurement
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Determining the amount of liver tissue fibrosis by using Elastography (2D Shear Wave Elastography- SWE)
2
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Description
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liver steatosis
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Timepoint
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Before and 16 weekes after the intervention
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Method of measurement
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Determining the amount of liver tissue steatosis by using Elastography (2D Shear Wave Elastography- SWE)
Secondary outcomes
1
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Description
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Liver function tests (LDH ،ALT،AST،Albumin ،GGT ،ALP،Bilirubin Total and Bilirubin Direct)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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lab kit
2
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Description
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Lipid profile (HDL-c, LDL-c, TG, TC)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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lab kit
3
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Description
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Fasting glucose, serum insulin
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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lab kit
4
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Description
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Inflammatory factors Hs-CRP and ESR
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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lab kit
5
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Description
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Anthropometric indicators (weight)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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Weight of a person with light clothes and without shoes (Kg)
6
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Description
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Anthropometric indicators (waist circumference)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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Waist size in the distance between the hip bone and the last rib (cm)
7
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Description
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Anthropometric indices (body mass index)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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The ratio of weight (in kilograms) to the square of height (in meters)
8
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Description
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Anthropometric indicators (fat mass and fat-free mass)
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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Using the body composition device
9
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Description
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blood pressure
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Timepoint
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Baseline and 16 weeks
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Method of measurement
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Measurement of systolic and diastolic blood pressure (mm Hg)
Intervention groups
1
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Description
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Intervention group:Nanocurcumin 40 mg Exir Nano Sina (twice a day),The patients will be received 1 capsule of 40 mg of nano curcumin two times daily for 4 months.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (twice a day), The patients will be received 1 capsule of an identical-looking placebo two times daily for 4 months (Appearance similarity of both supplement and placebo in terms of shape and color).
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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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Dr. Amin Salehi Abargouei/ Vice Chancellor of Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd
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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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Yazd 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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Yes - There is a plan to make this available
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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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Yes - There is 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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Not applicable
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Title and more details about the data/document
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Data collected for the primary and secondary outcomes will be shared.
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When the data will become available and for how long
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Access starting 6 months after publication
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To whom data/document is available
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he data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by for conducting Meta-analysis.
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From where data/document is obtainable
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To access the required data, the researchers can contact Dr. Sayyed Saeid Khayyatzadeh: email address: khayyatzadeh@yahoo.com
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What processes are involved for a request to access data/document
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The request will be assessed by the our group, and if all of us agree to the request, the requested data will be emailed.
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Comments
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