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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General information
2023-04-20, 1402/01/31
2024-12-20, 1403/09/30
20232024-0412-20 00:00:00
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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.
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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کارآزمایی بالینی مذکور در بهار سال 1402 ثبت شد و بیمار گیری نیز پس از ثبت شروع شد و اکنون در مرداد ماه سال 1403 هنوز بیمارگیری این کارآزمایی بالینی به اتمام نرسیده است اما متاسفانه در زمان ثبت کارآزمایی بالینی در سامانه IRCT، تاریخ مورد انتظار اتمام طرح، به علت یک خطای غیر عمد مشابه با تاریخ شروع نوشته شد و کارآزمایی بالینی مذکور از همان ابتدا به صورت یک کارآزمایی بالینی خاتمه یافته و گذشته نگر ثبت گردید، در صورتی که اکنون در مرداد سال 1403، همان طور که بیان شد، بیمارگیری ما خاتمه نیافته است.
کارآزمایی بالینی مذکور در بهار سال 1402 ثبت شد و بیمار گیری نیز پس از ثبت شروع شد و اکنون در مرداد ماه سال 1403 هنوز بیمارگیری این کارآزمایی بالینی به اتمام نرسیده است اما متاسفانه در زمان ثبت کارآزمایی بالینی در سامانه IRCT، تاریخ مورد انتظار اتمام طرح، به علت یک خطای غیر عمد مشابه با تاریخ شروع نوشته شد و کارآزمایی بالینی مذکور از همان ابتدا به صورت یک کارآزمایی بالینی خاتمه یافته و گذشته نگر ثبت گردید، در صورتی که اکنون در مرداد سال 1403، همان طور که بیان شد، بیمارگیری ما خاتمه نیافته است.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sayyed Saeid Khayyatzadeh
Full name of responsible person - Persian: سید سعید خیاط زاده
Street address - English: Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
Street address - Persian: یزد – میدان عالم – بلوار شهدای گمنام – پردیس دانشگاه علوم پزشکی شهید صدوقی يزد – دانشکده بهداشت - گروه تغذيه
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۵۱۷۳۱۶۰
Phone: +98 35 3149 2228
Fax:
Email: khayyatzadeh@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Salehi Abargouei
Full name of responsible person - Persian: امین صالحی ابرقویی
Street address - English: Yazd - Imam Hossein Square - Student Blvd - Imam Reza Research Educational Complex - Vice President of Research and Technology of Shahid Sadougi University of Medical Sciences, Yazd
Street address - Persian: یزد – میدان امام حسین (ع) -ابتدای بلوار دانشجو – مجتمع آموزشی پژوهشی امام رضا (ع) – معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۱۸۸۶۳۷
Phone: +98 35 3623 8506
Fax:
Email: dvc.research@ssu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sayyed Saeid KhayyatzadehAmin Salehi Abargouei Full name of responsible person - Persian: سید سعید خیاط زادهامین صالحی ابرقویی Street address - English: Yazd - AlamImam Hossein Square - Student Blvd - Imam Reza Research Educational Complex - Vice President of Research and Technology of Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition, Yazd Street address - Persian: یزد – میدان عالمامام حسین (ع) -ابتدای بلوار دانشجو – بلوار شهدای گمناممجتمع آموزشی پژوهشی امام رضا (ع) – پردیسمعاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی يزد – دانشکده بهداشت - گروه تغذيهیزد City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۵۶۱۸۸۶۳۷۳۱۶۰ Phone: +98 35 3149 22283623 8506 Fax: Email: khayyatzadehdvc.research@yahoo.comssu.ac.ir Web page address:
Protocol summary
Study aim
The effects of nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. Blocked randomization will be used for randomization.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
1 capsule of 40 mg of nanocurcumin or 1 capsule of identical-looking placebo two times daily.
Main outcome variables
liver fibrosis and steatosis
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2023-04-20, 1402/01/31
Registrant information
Name
Sayyed Saeid Khayyatzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
khayyatzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-20, 1402/01/31
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of Nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin
Public title
The effect of Nanocurcumin on liver fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.SSU.SPH.REC.1401.157
Health conditions studied
1
Description of health condition studied
Liver fibrosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
liver fibrosis
Timepoint
Before and 16 weekes after the intervention
Method of measurement
Determining the amount of liver tissue fibrosis by using Elastography (2D Shear Wave Elastography- SWE)
2
Description
liver steatosis
Timepoint
Before and 16 weekes after the intervention
Method of measurement
Determining the amount of liver tissue steatosis by using Elastography (2D Shear Wave Elastography- SWE)
Secondary outcomes
1
Description
Liver function tests (LDH ،ALT،AST،Albumin ،GGT ،ALP،Bilirubin Total and Bilirubin Direct)
Timepoint
Baseline and 16 weeks
Method of measurement
lab kit
2
Description
Lipid profile (HDL-c, LDL-c, TG, TC)
Timepoint
Baseline and 16 weeks
Method of measurement
lab kit
3
Description
Fasting glucose, serum insulin
Timepoint
Baseline and 16 weeks
Method of measurement
lab kit
4
Description
Inflammatory factors Hs-CRP and ESR
Timepoint
Baseline and 16 weeks
Method of measurement
lab kit
5
Description
Anthropometric indicators (weight)
Timepoint
Baseline and 16 weeks
Method of measurement
Weight of a person with light clothes and without shoes (Kg)
6
Description
Anthropometric indicators (waist circumference)
Timepoint
Baseline and 16 weeks
Method of measurement
Waist size in the distance between the hip bone and the last rib (cm)
7
Description
Anthropometric indices (body mass index)
Timepoint
Baseline and 16 weeks
Method of measurement
The ratio of weight (in kilograms) to the square of height (in meters)
8
Description
Anthropometric indicators (fat mass and fat-free mass)
Timepoint
Baseline and 16 weeks
Method of measurement
Using the body composition device
9
Description
blood pressure
Timepoint
Baseline and 16 weeks
Method of measurement
Measurement of systolic and diastolic blood pressure (mm Hg)
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Street address
Tehran, Kargar North Street, Jalal Al Ahmad three way, Dr. Shariati Educational Research and Treatment Center.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
info@ddri.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Yazd - Imam Hossein Square - Student Blvd - Imam Reza Research Educational Complex - Vice President of Research and Technology of Shahid Sadougi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3623 8506
Email
dvc.research@ssu.ac.ir
Grant name
Dr. Amin Salehi Abargouei/ Vice Chancellor of Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadis Gerami
Position
PhD student in nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3149 2228
Email
geramihadis@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3149 2228
Email
khayyatzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadis Gerami
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3149 2228
Email
geramihadis@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data collected for the primary and secondary outcomes will be shared.
When the data will become available and for how long
Access starting 6 months after publication
To whom data/document is available
he data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by for conducting Meta-analysis.
From where data/document is obtainable
To access the required data, the researchers can contact Dr. Sayyed Saeid Khayyatzadeh: email address: khayyatzadeh@yahoo.com
What processes are involved for a request to access data/document
The request will be assessed by the our group, and if all of us agree to the request, the requested data will be emailed.