Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients
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Protocol summary
Inclusion criteria:
Age 20-60 years
Diagnosis of Behcet's disease by rheumatologist
Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease
Exclusion criteria:
Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; Using corticosteroids during illness; Admission rate<70% of supplemental intake; Smoking
Inclusion criteria:
Age 20-60 years
Diagnosis of Behcet's disease by rheumatologist
Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease
Exclusion criteria:
Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; Admission rate<70% of supplemental intake; Smoking
Inclusion criteria: Age 20-60 years Diagnosis of Behcet's disease by rheumatologist Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease Exclusion criteria: Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; Using corticosteroids during illness; Admission rate<70% of supplemental intake; Smoking
معیار ورود:
•محدوده سنی 20 تا 60 سال
•تشخیص بیماری بهجت توسط فوق تخصص روماتولوژی
•انتخاب بیماران بر اساس کرایتریاهای IBCD(The International Criteria for Behcet’s Disease) صورت خواهد گرفت که بر این اساس، درگیری های تهدید کننده ی عروق، چشم و مفاصل ، نشان دهنده ی شدت بیماری است.
معیار عدم ورود:
- مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه
- بارداری و شیردهی
- سابقه ابتلا به دیابت و سایر بیماریهای مزمن
- سابقه ابتلا به سایر بیماریهای اتوایمن
- مصرف داروهای کورتونی در طول بیماری
- میزان پذیرش کمتر از 70% درصد مصرف مکمل
- استعمال سیگار
معیار ورود:
•محدوده سنی 20 تا 60 سال
•تشخیص بیماری بهجت توسط فوق تخصص روماتولوژی
•انتخاب بیماران بر اساس کرایتریاهای IBCD(The International Criteria for Behcet’s Disease) صورت خواهد گرفت که بر این اساس، درگیری های تهدید کننده ی عروق، چشم و مفاصل ، نشان دهنده ی شدت بیماری است.
معیار عدم ورود:
- مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه
- بارداری و شیردهی
- سابقه ابتلا به دیابت و سایر بیماریهای مزمن
- سابقه ابتلا به سایر بیماریهای اتوایمن
- میزان پذیرش کمتر از 70% درصد مصرف مکمل
- استعمال سیگار
معیار ورود: •محدوده سنی 20 تا 60 سال •تشخیص بیماری بهجت توسط فوق تخصص روماتولوژی •انتخاب بیماران بر اساس کرایتریاهای IBCD(The International Criteria for Behcet’s Disease) صورت خواهد گرفت که بر این اساس، درگیری های تهدید کننده ی عروق، چشم و مفاصل ، نشان دهنده ی شدت بیماری است. معیار عدم ورود: - مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه - بارداری و شیردهی - سابقه ابتلا به دیابت و سایر بیماریهای مزمن - سابقه ابتلا به سایر بیماریهای اتوایمن - مصرف داروهای کورتونی در طول بیماری - میزان پذیرش کمتر از 70% درصد مصرف مکمل - استعمال سیگار
General information
- This study is a double-blind clinical trial.
- Sample size is considered 18 subjects per group with a possible dropout rate.
- Duration of intervention is 2 months.
- Use of corticosteroids during illness is removed from exclusion criteria.
- This studyUse of corticosteroids during illness is a double-blind clinical trialremoved from exclusion criteria. - Sample size is considered 18 subjects per group with a possible dropout rate. - Duration of intervention is 2 months.
- مطالعه حاضر یک کارآزمایی بالینی دو سوکور است.
- حجم نمونه مورد مطالعه با احتساب ریزش 18 نفر در هر گروه در نظر گرفته شده است.
- طول مدت مداخله 2 ماه است.
- مصرف داروهای کورتونی در طول بیماری از معیارهای عدم ورود حذف گردید.
- مطالعه حاضر یک کارآزمایی بالینی دو سوکور است. - حجم نمونه مورد مطالعه با احتساب ریزش 18 نفرمصرف داروهای کورتونی در هر گروه در نظر گرفته شده است. - طول مدت مداخله 2 ماه استبیماری از معیارهای عدم ورود حذف گردید.
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study
Pregnancy and lactation
History of diabetes and other chronic diseases
The history of other autoimmune diseases
Use of corticosteroids during illness
Admission rate less than 70% of supplemental intake
Smoking
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study
Pregnancy and lactation
History of diabetes and other chronic diseases
The history of other autoimmune diseases
Admission rate less than 70% of supplemental intake
Smoking
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study Pregnancy and lactation History of diabetes and other chronic diseases The history of other autoimmune diseases Use of corticosteroids during illness Admission rate less than 70% of supplemental intake Smoking
مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه
بارداری و شیردهی
سابقه ابتلا به دیابت و سایر بیماریهای مزمن
سابقه ابتلا به سایر بیماریهای اتوایمن
مصرف داروهای کورتونی در طول بیماری
میزان پذیرش کمتر از 70% درصد مصرف مکمل
استعمال سیگار
مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه
بارداری و شیردهی
سابقه ابتلا به دیابت و سایر بیماریهای مزمن
سابقه ابتلا به سایر بیماریهای اتوایمن
میزان پذیرش کمتر از 70% درصد مصرف مکمل
استعمال سیگار
مصرف مکملهای تغذیه ای و آنتی اکسیدانی و آلفا لیپوئیک اسید در طی یک ماه قبل از مطالعه بارداری و شیردهی سابقه ابتلا به دیابت و سایر بیماریهای مزمن سابقه ابتلا به سایر بیماریهای اتوایمن مصرف داروهای کورتونی در طول بیماری میزان پذیرش کمتر از 70% درصد مصرف مکمل استعمال سیگار
Protocol summary
Study aim
Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17 level in Behcet patients
Design
ِDouble-blinded clinical trial with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n=18) receiving placebo capsules and treated group (n=18) receiving nanocurcumin capsules
Settings and conduct
In this study, the patients with Behcet's syndrome is studied. These individuals are selected randomly from among referrals to rheumatologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group will receive 80 mg of nanocurcumin
The control group will also receive placebo capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20-60 years
Diagnosis of Behcet's disease by rheumatologist
Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease
Exclusion criteria:
Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; Admission rate<70% of supplemental intake; Smoking
Intervention groups
The treatment group will receive 80 mg of nanocurcumin
The control group will also receive placebo capsules.
Main outcome variables
In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 155, miRNA181, the frequency of Treg calls and Th17 cells, the expression of the RoRγt، Foxp3, the expression of the IL-23 and IL-17, IL-10 ، TGF-b , and the secretion levels of these cytokines in patients with Behcet disease compared with the control group.
General information
Reason for update
- Use of corticosteroids during illness is removed from exclusion criteria.
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N12
Registration date:2019-05-09, 1398/02/19
Registration timing:prospective
Last update:2021-10-15, 1400/07/23
Update count:3
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients
Public title
Effect of oral nanocurcumin in patients with Behcet's disease.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Age range 20 to 60 years
Diagnosis of Behcet's disease by rheumatologist
Exclusion criteria:
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study
Pregnancy and lactation
History of diabetes and other chronic diseases
The history of other autoimmune diseases
Admission rate less than 70% of supplemental intake
Smoking
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 36 individuals will be selected by simple randomization.
Randomization method: Blocking
Randomization unit: individual
stratification: age and sex
Randomization tool: Random allocation software
Method of random sequence generation: Random allocation software
Allocation concealment: The generated random sequence will be kept in a protected location and administered by an independent party who is not involved in the trial throughout the study. Due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which the researcher and patients who participate in study will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in doing the assessment and chemical analysis. Patients will be informed about the type of supplements (nanocurcumin and placebo) however they will not be aware about the group assignments.
Placebo capsules are identical to nanocurcumin supplements in shape and color and size.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
GOLGASHT, University Avenue,Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.TBZMED.REC.1398.037
Health conditions studied
1
Description of health condition studied
Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
The expression of miRNAs
Timepoint
Before and after intervention
Method of measurement
QRT-PCR
2
Description
Frequency of Th17 cells
Timepoint
Before and after intervention
Method of measurement
Flow cytometry
3
Description
The expression of the RoRγ
Timepoint
Before and after intervention
Method of measurement
QRT-PCR
4
Description
IL-23 and IL-17 cytokine gene expression
Timepoint
Before and after intervention
Method of measurement
QRT-PCR
5
Description
The level of IL-23 and IL-17 cytokine secretion
Timepoint
Before and after intervention
Method of measurement
Elisa
6
Description
Frequency of Treg cells
Timepoint
Before and after intervention
Method of measurement
Flow cytometry
7
Description
The expression of the Foxp3
Timepoint
Before and after intervention
Method of measurement
QRT-PCR
8
Description
TGF-b and IL-10 cytokine gene expression
Timepoint
Before and after intervention
Method of measurement
QRT-PCR
9
Description
The level of TGF-b and IL-10 cytokine secretion
Timepoint
Before and after intervention
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nanocurcumin Patients in intervention group will take one 80 mg nanocurcumin capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 months.
Category
Treatment - Other
2
Description
Control group: Placebo Patients in control group will take one placebo capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 months.