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Protocol summary
To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis, patients with clinical symptoms and MRI results , who their disease is diagnosed by neurological specialist definitively be referred the person in charge of research. Subjects examined by a neurologist and then determine the EDSS and approved the inclusion criteria to take a placebo or supplements will be introduced to researcher. In this study, after receiving written consent from the patient, personal information and history will be recorded. After completing the questionnaire and obtaining the necessary information 8 cc of fasting blood will be taken from each patient .Patients randomly block (block randomization) in the control group (n = 25) and supplements (n = 25) are placed. The supplement, 80 mg will receive nanocurcumin and the control group will receive placebo. During the 6-month period of study patients will take the capsule daily. In the end of study, 8 cc of fasting blood will be taken from patients who received nanocurcumin and placebo and then will be completed questionnaires and obtaining the necessary information.
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To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis, patients with clinical symptoms and MRI results , who their disease is diagnosed by neurological specialist definitively be referred the person in charge of research. Subjects examined by a neurologist and then determine the EDSS and approved the inclusion criteria to take a placebo or supplements will be introduced to researcher. In this study, after receiving written consent from the patient, personal information and history will be recorded. After completing the questionnaire and obtaining the necessary information 8 cc of fasting blood will be taken from each patient .Patients randomly block (block randomization) in the control group (n = 25) and supplements (n = 25) are placed. The supplement, 80 mg will receive nanocurcumin and the control group will receive placebo. During the 6-month period of study patients will take the capsule daily. In the end of study, 8 cc of fasting blood will be taken from patients who received nanocurcumin and placebo and then will be completed questionnaires and obtaining the necessary information.
به منظور بررسی اثرات نانوکورکومین خوراکی بر میزان بیان میکرو RNA ها و فاکتورهای موثر در تکامل سلول های Treg و Th17 در بیماران مبتلا به مالتیپل اسکلروزیس، بیمارانی که بر اساس علایم بالینی و بررسی نتایج MRI توسط پزشک متخصص نورولوژی بیماری ام اس آنها به طور قطعی تشخیص داده می شود به فرد مسئول پژوهش ارجاع داده خواهند شد. افراد مورد مطالعه توسط پزشک متخصص نورولوژی طرح معاینه شده و پس از تعیین میزان EDSS و تایید شرایط ورود به مطالعه به همکار پژوهشی جهت گرفتن دارونما یا مکمل معرفی خواهند شد. در این مطالعه بعد از دریافت فرم رضایت نامه کتبی از بیمار ، مشخصات فردی و سوابق بیماری ثبت خواهد گردید. پس از تکمیل پرسشنامه ها و اخذ اطلاعات لازم در حالت ناشتا از هر بیمار 8 سی سی خون وریدی گرفته خواهد شد. بیماران به روش تصادفی بلوک بندی( block randomization) در دو گروه کنترل (25 نفر) و مکمل(25 نفر) قرار می گیرند. گروه مکمل 80 میلی گرم نانوکورکومین و گروه کنترل نیز کپسول دارونما دریافت خواهند کرد. از بیماران می خواهیم که در طول 6 ماه مدت مطالعه روزانه کپسول را مصرف کنند. در انتهای مطالعه نیز بیماران پس از طی دوره مطالعه به صورت ناشتا مراجعه کرده و پس از اخذ 8 سی سی خون پرسشنامه ها و اطلاعات لازم اخذ و تکمیل خواهد گردید.
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به منظور بررسی اثرات نانوکورکومین خوراکی بر میزان بیان میکرو RNA ها و فاکتورهای موثر در تکامل سلول های Treg و Th17 در بیماران مبتلا به مالتیپل اسکلروزیس، بیمارانی که بر اساس علایم بالینی و بررسی نتایج MRI توسط پزشک متخصص نورولوژی بیماری ام اس آنها به طور قطعی تشخیص داده می شود به فرد مسئول پژوهش ارجاع داده خواهند شد. افراد مورد مطالعه توسط پزشک متخصص نورولوژی طرح معاینه شده و پس از تعیین میزان EDSS و تایید شرایط ورود به مطالعه به همکار پژوهشی جهت گرفتن دارونما یا مکمل معرفی خواهند شد. در این مطالعه بعد از دریافت فرم رضایت نامه کتبی از بیمار ، مشخصات فردی و سوابق بیماری ثبت خواهد گردید. پس از تکمیل پرسشنامه ها و اخذ اطلاعات لازم در حالت ناشتا از هر بیمار 8 سی سی خون وریدی گرفته خواهد شد. بیماران به روش تصادفی بلوک بندی( block randomization) در دو گروه کنترل (25 نفر) و مکمل(25 نفر) قرار می گیرند. گروه مکمل 80 میلی گرم نانوکورکومین و گروه کنترل نیز کپسول دارونما دریافت خواهند کرد. از بیماران می خواهیم که در طول 6 ماه مدت مطالعه روزانه کپسول را مصرف کنند. در انتهای مطالعه نیز بیماران پس از طی دوره مطالعه به صورت ناشتا مراجعه کرده و پس از اخذ 8 سی سی خون پرسشنامه ها و اطلاعات لازم اخذ و تکمیل خواهد گردید.
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To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis
To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis
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بررسی اثرات نانوکورکومین خوراکی بر میزان بیان میکرو RNA ها و فاکتورهای موثر در تکامل سلول های Treg و Th17 در بیماران مبتلا به مالتیپل اسکلروزیس
بررسی اثرات نانوکورکومین خوراکی بر میزان بیان میکرو RNA ها و فاکتورهای موثر در تکامل سلول های Treg و Th17 در بیماران مبتلا به مالتیپل اسکلروزیس
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Clinical trials with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n = 25) receiving placebo capsules and treated group (n = 25) receiving nanocurcumin capsules
Clinical trials with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n = 25) receiving placebo capsules and treated group (n = 25) receiving nanocurcumin capsules
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده. بیماران به روش تصادفی در دو گروه کنترل (25 نفر) دریافت کننده کپسول دارونما و گروه مکمل دریافت کننده نانوکورکومین (25 نفر) قرار گرفتند.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده. بیماران به روش تصادفی در دو گروه کنترل (25 نفر) دریافت کننده کپسول دارونما و گروه مکمل دریافت کننده نانوکورکومین (25 نفر) قرار گرفتند.
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In this study, patients with multiple sclerosis is studied. These individuals are selected randomly from among referrals to neurologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group received 80 mg of nanocurcumin The control group also received placebo capsules.
In this study, patients with multiple sclerosis is studied. These individuals are selected randomly from among referrals to neurologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group received 80 mg of nanocurcumin The control group also received placebo capsules.
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در این بررسی جمعیت بیماران مبتلا به مالتیپل اسکلروزیس مورد مطالعه قرار 'گرفتند این افراد بر اساس یافته های آزمایشگاهی و محتوای پرونده پزشکی با نظر پزشک متخصص ، بصورت تصادفی از میان مراجعه کنندگان به متخصص مغز و اعصاب در دانشگاه علوم پزشکی تبریز انتخاب می گردند. گروه مکمل 80 میلی گرم نانوکورکومین دریافت کردند. گروه کنترل نیز کپسول دارونما دریافت کردند.
در این بررسی جمعیت بیماران مبتلا به مالتیپل اسکلروزیس مورد مطالعه قرار 'گرفتند این افراد بر اساس یافته های آزمایشگاهی و محتوای پرونده پزشکی با نظر پزشک متخصص ، بصورت تصادفی از میان مراجعه کنندگان به متخصص مغز و اعصاب در دانشگاه علوم پزشکی تبریز انتخاب می گردند. گروه مکمل 80 میلی گرم نانوکورکومین دریافت کردند. گروه کنترل نیز کپسول دارونما دریافت کردند.
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Inclusion criteria:
Ranging in age from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Exclusion criteria:
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase
Inclusion criteria: Ranging in age from 28 to 51 years MS diagnosis by neurologist patients in relapse and remitting EDSS<5/5 Exclusion criteria: History of diabetes and other chronic diseases; History of other autoimmune disease; corticosteroid use during illness; the occurrence of relapses during the study phase
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شرایط ورورد :
محدوده سنی 28تا 51 سال
تشخیص بیماری ام اس توسط متخصص مغز و اعصاب
قرارگرفتن بیماران در مرحله عود و بهبود (RRMS)؛
EDSS<5/5
شرایط عدم ورود: سابقه ابتلا به دیابت و سایر بیماریهای مزمن , سایر بیماریهای اتوایمن؛
مصرف داروهای کورتونی در طول بیماری ؛
وقوع مرحله عود بیماری در طول مطالعه؛
شرایط ورورد : محدوده سنی 28تا 51 سال تشخیص بیماری ام اس توسط متخصص مغز و اعصاب قرارگرفتن بیماران در مرحله عود و بهبود (RRMS)؛ EDSS<5/5 شرایط عدم ورود: سابقه ابتلا به دیابت و سایر بیماریهای مزمن , سایر بیماریهای اتوایمن؛ مصرف داروهای کورتونی در طول بیماری ؛ وقوع مرحله عود بیماری در طول مطالعه؛
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Intervention group: nanocurcumin Patients in intervention group took nanocurcumin capsules on a daily basis over a period of 6 months.
Control group: Placebo The control capsule took on a daily basis over a period of 6 months.
Intervention group: nanocurcumin Patients in intervention group took nanocurcumin capsules on a daily basis over a period of 6 months. Control group: Placebo The control capsule took on a daily basis over a period of 6 months.
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گروه مداخله: نانوکورکومین . بیماران در گروه مداخله که کپسولهای نانوکورکومین را در طول 6 ماه مدت مطالعه به صورت روزانه مصرف کردند.
گروه کنترل: دارونما گروه کنترل کپسول دارونما در طول 6 ماه مدت مطالعه به صورت روزانه مصرف کردند.
گروه مداخله: نانوکورکومین . بیماران در گروه مداخله که کپسولهای نانوکورکومین را در طول 6 ماه مدت مطالعه به صورت روزانه مصرف کردند. گروه کنترل: دارونما گروه کنترل کپسول دارونما در طول 6 ماه مدت مطالعه به صورت روزانه مصرف کردند.
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In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 106, miRNA25, 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 multiple sclerosis compared with the control group.
In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 106, miRNA25, 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 multiple sclerosis compared with the control group.
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در این مطالعه اثرات نانوکورکومین خوراکی بر میزان بیان miRNA326، miRNA 106، miRNA25 ، بر میزان فراوانی سلول های Th17 , Treg ، میزان بیان فاکتور نسخه برداری RoRγt، Foxp3 ، میزان بیان ژن سایتوکاین های IL-23 و IL-17 ، IL-10 ، TGF-b، میزان ترشح سایتوکاین های مذکور دربیماران مبتلا به مالتیپل اسکلروزیس در مقایسه با گروه کنترل بررسی گردید.
در این مطالعه اثرات نانوکورکومین خوراکی بر میزان بیان miRNA326، miRNA 106، miRNA25 ، بر میزان فراوانی سلول های Th17 , Treg ، میزان بیان فاکتور نسخه برداری RoRγt، Foxp3 ، میزان بیان ژن سایتوکاین های IL-23 و IL-17 ، IL-10 ، TGF-b، میزان ترشح سایتوکاین های مذکور دربیماران مبتلا به مالتیپل اسکلروزیس در مقایسه با گروه کنترل بررسی گردید.
General information
18
28
1828
Single blinded
Double blinded
singldoubl
1
1
1
1
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41
41
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2016-06-08, 1395/03/19
2016-06-08 00:00:00
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2016-08-10, 1395/05/20
2016-08-10 00:00:00
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2017-11-07, 1396/08/16
2017-11-07 00:00:00
Willingness to cooperate;
Ranging in age from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Willingness to cooperate; Ranging in age from 28 to 51 years MS diagnosis by neurologist patients in relapse and remitting EDSS<5/5
تمایل به همکاری
محدوده سنی 28تا 51 سال
تشخیص بیماری ام اس توسط متخصص مغز و اعصاب
قرارگرفتن بیماران در مرحله عود و بهبود (RRMS)؛
EDSS<5/5
تمایل به همکاری محدوده سنی 28تا 51 سال تشخیص بیماری ام اس توسط متخصص مغز و اعصاب قرارگرفتن بیماران در مرحله عود و بهبود (RRMS)؛ EDSS<5/5
Used nutritional supplements and antioxidants and alpha lipoic acid within a month before the study
Pregnancy and lactation;
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase;
acceptance rate of less than 70% of supplements;
not wanting to continue cooperation.
Used nutritional supplements and antioxidants and alpha lipoic acid within a month before the study Pregnancy and lactation; History of diabetes and other chronic diseases; History of other autoimmune disease; corticosteroid use during illness; the occurrence of relapses during the study phase; acceptance rate of less than 70% of supplements; not wanting to continue cooperation.
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 ؛
وقوع مرحله عود بیماری در طول مطالعه؛
میزان پذیرش کمتر از 70% درصد مصرف مکمل
عدم تمایل به ادامه همکاری.
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 ؛ وقوع مرحله عود بیماری در طول مطالعه؛ میزان پذیرش کمتر از 70% درصد مصرف مکمل عدم تمایل به ادامه همکاری.
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Block randomization
Blocking were used to balance the number of samples assigned to each study groups . The size of all blocks is equal and the blocks included 25 participants in the intervention group, who receive nanocurcumin capsules and 25 participants in the control group who receive placebo capsules.
Block randomization Blocking were used to balance the number of samples assigned to each study groups . The size of all blocks is equal and the blocks included 25 participants in the intervention group, who receive nanocurcumin capsules and 25 participants in the control group who receive placebo capsules.
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تصادفی بلوک بندی
بلوك بندي به منظور ايجـاد تـوازن در تعداد نمونه هاي تخصيص يافته به هر يك از
گـروههـاي مـورد مطالعـه اسـتفاده شد. اندازه كليه بلـوكهـا برابـر است و بلوكهـاي شامل 25 شركت كننده در گروه مداخلـه که کپسول های نانوکورکومین و 25 شركت كننـده در گـروه کنترل که کپسول دارونما دریافت خواهند کرد، است.
تصادفی بلوک بندی بلوك بندي به منظور ايجـاد تـوازن در تعداد نمونه هاي تخصيص يافته به هر يك از گـروههـاي مـورد مطالعـه اسـتفاده شد. اندازه كليه بلـوكهـا برابـر است و بلوكهـاي شامل 25 شركت كننده در گروه مداخلـه که کپسول های نانوکورکومین و 25 شركت كننـده در گـروه کنترل که کپسول دارونما دریافت خواهند کرد، است.
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1. Participant
2. Outcome assessor
1. Participant 2. Outcome assessor
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1. شرکت کننده
2. ارزیابی کننده پیامد
1. شرکت کننده 2. ارزیابی کننده پیامد
50 patients
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50 patients
50 بیمار
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50 بیمار
Secondary Ids
#1
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ClinicalTrials.gov
ClinicalTrials.gov
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NCT03150966
NCT03150966
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2017-05-12, 1396/02/22
2017-05-12 00:00:00
Intervention groups
#1
گروه کنترل کپسول های دارونما را یک بار در روز به مدت شش ماه دریافت می کنند.
گروه کنترل کپسول های دارونما را یک بار در روز به مدت شش ماه دریافت نمودند.
گروه کنترل کپسول های دارونما را یک بار در روز به مدت شش ماه دریافت می کنندنمودند.
#2
گروه مکمل کپسول های نانوکورکومین حاوی 80 میلی گرم نانوکورکومین را یک بار در روز به مدت شش ماه دریافت می کنند.
گروه مکمل کپسول های نانوکورکومین حاوی 80 میلی گرم نانوکورکومین را یک بار در روز به مدت شش ماه دریافت نمودند.
گروه مکمل کپسول های نانوکورکومین حاوی 80 میلی گرم نانوکورکومین را یک بار در روز به مدت شش ماه دریافت می کنندنمودند.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Hospital, Tabriz
Name of recruitment center - Persian: بیمارستان امام رضا ، تبریز
Full name of responsible person - English: Mehdi Yousefi, Ph.D Of Medical Immunology
Full name of responsible person - Persian: مهدی یوسفی، Ph.D ایمنی شناسی پزشکی
Street address - English: Imam Reza Hospital, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Imam Reza Hospital, Tabriz
Name of recruitment center - Persian: بیمارستان امام رضا ، تبریز
Full name of responsible person - English: Mehdi Yousefi, Ph.D Of Medical Immunology
Full name of responsible person - Persian: مهدی یوسفی، Ph.D ایمنی شناسی پزشکی
Street address - English: Imam Reza Hospital, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3336 4665
Fax:
Email: yousefime@tbzmed.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Hospital, Tabriz Name of recruitment center - Persian: بیمارستان امام رضا ، تبریز Full name of responsible person - English: Mehdi Yousefi, Ph.D Of Medical Immunology Full name of responsible person - Persian: مهدی یوسفی، Ph.D ایمنی شناسی پزشکی Street address - English: Imam Reza Hospital, Golgasht Avenue, Tabriz Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3336 4665 Fax: Email: yousefime@tbzmed.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Drug Applied Research Center
Name of organization / entity - Persian: مرکز تحقیقات کاربردی دارویی
Full name of responsible person - English: Hossein Babaei
Full name of responsible person - Persian: دکتر حسین بابایی
Street address - English: Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Street address - Persian: تبریز، دانشگاه علوم پزشکی تبریز، مرکز تحقیقات کاربردی دارویی
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Drug Applied Research Center
Name of organization / entity - Persian: مرکز تحقیقات کاربردی دارویی
Full name of responsible person - English: Hossein Babaei
Full name of responsible person - Persian: دکتر حسین بابایی
Street address - English: Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Street address - Persian: تبریز، دانشگاه علوم پزشکی تبریز، مرکز تحقیقات کاربردی دارویی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3336 4665
Fax:
Email: yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Drug Applied Research Center Name of organization / entity - Persian: مرکز تحقیقات کاربردی دارویی Full name of responsible person - English: Hossein Babaei Full name of responsible person - Persian: دکتر حسین بابایی Street address - English: Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz Street address - Persian: تبریز، دانشگاه علوم پزشکی تبریز، مرکز تحقیقات کاربردی دارویی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3336 4665 Fax: Email: yousefime@tbzmed.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3336 4665
Mobile: 00
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree: phd
Area of specialty/work: 12
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3336 4665
Mobile: +98 912 670 3953
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Mehdi Yousefi Full name of responsible person - Persian: مهدی یوسفی Position - English: Ph.D Of Medical Immunology / Assistant Professor Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار Latest degree: phd Area of specialty/work: 012 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3336 4665 Mobile: 00+98 912 670 3953 Fax: Email: Yousefime@tbzmed.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3336 4665
Mobile: 00
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree: phd
Area of specialty/work: 12
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3336 4665
Mobile: +98 912 670 3953
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Mehdi Yousefi Full name of responsible person - Persian: مهدی یوسفی Position - English: Ph.D Of Medical Immunology / Assistant Professor Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار Latest degree: phd Area of specialty/work: 012 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3336 4665 Mobile: 00+98 912 670 3953 Fax: Email: Yousefime@tbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 41 3336 4665
Mobile: 00
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mehdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Position - English: Ph.D Of Medical Immunology / Assistant Professor
Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار
Latest degree: phd
Area of specialty/work: 12
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3336 4665
Mobile: +98 912 670 3953
Fax:
Email: Yousefime@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Mehdi Yousefi Full name of responsible person - Persian: مهدی یوسفی Position - English: Ph.D Of Medical Immunology / Assistant Professor Position - Persian: Ph.D ایمنی شناسی پزشکی/ استادیار Latest degree: phd Area of specialty/work: 012 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3336 4665 Mobile: 00+98 912 670 3953 Fax: Email: Yousefime@tbzmed.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
na
na
na
na
na
na
empty
No more information
No more information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
To evaluate the effects of oral nanocurcumin, in levels of micro-RNAs expression and Treg and Th17 cell development factors in patients with multiple sclerosis
Design
Clinical trials with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n = 25) receiving placebo capsules and treated group (n = 25) receiving nanocurcumin capsules
Settings and conduct
In this study, patients with multiple sclerosis is studied. These individuals are selected randomly from among referrals to neurologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group received 80 mg of nanocurcumin The control group also received placebo capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ranging in age from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Exclusion criteria:
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase
Intervention groups
Intervention group: nanocurcumin Patients in intervention group took nanocurcumin capsules on a daily basis over a period of 6 months.
Control group: Placebo The control capsule took on a daily basis over a period of 6 months.
Main outcome variables
In this study, the effect of oral nanocurcumin were investigated on the expression of miRNA326, miRNA 106, miRNA25, 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 multiple sclerosis compared with the control group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2016042227520N1
Registration date:2016-05-29, 1395/03/09
Registration timing:prospective
Last update:2019-09-04, 1398/06/13
Update count:1
Registration date
2016-05-29, 1395/03/09
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
Drug Applied Research Center Tabriz University Of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
2016-06-08, 1395/03/19
Actual recruitment end date
2016-08-10, 1395/05/20
Trial completion date
2017-11-07, 1396/08/16
Scientific title
The effects of oral nanocurcumin on expression levels of microRNAs and Treg cells and Th17 cells development factors in Multiple Sclerosis patients
Public title
The effects of oral nanocurcumin in Multiple Sclerosis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate;
Ranging in age from 28 to 51 years
MS diagnosis by neurologist
patients in relapse and remitting
EDSS<5/5
Exclusion criteria:
Used nutritional supplements and antioxidants and alpha lipoic acid within a month before the study
Pregnancy and lactation;
History of diabetes and other chronic diseases;
History of other autoimmune disease;
corticosteroid use during illness;
the occurrence of relapses during the study phase;
acceptance rate of less than 70% of supplements;
not wanting to continue cooperation.
Age
From 28 years old to 51 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blocking were used to balance the number of samples assigned to each study groups . The size of all blocks is equal and the blocks included 25 participants in the intervention group, who receive nanocurcumin capsules and 25 participants in the control group who receive placebo capsules.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. Participant
2. Outcome assessor
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT03150966
Registration date
2017-05-12, 1396/02/22
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
TBZMED.REC.1394.1177
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
miRNA-106b
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-106b by using Quantitative Real time PCR
2
Description
miRNA-25
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-25 by using Quantitative Real time PCR
3
Description
miRNA-326
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of miRNA-326 by using Quantitative Real time PCR
4
Description
The frequency of Treg cells
Timepoint
Before interference and six months after interference
Method of measurement
Examined the frequency of Treg cells by using flow cytometry
5
Description
The frequency of Th17 cells
Timepoint
Before interference and six months after interference
Method of measurement
Examined the frequency of Th17 cells by using flow cytometry
6
Description
Transcription factor: Foxp3
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of Foxp3 by using Quantitative Real time PCR
7
Description
Transcription factor: RoRγt
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of RoRγt by using Quantitative Real time PCR
8
Description
Cytokine: TGF-β
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of TGF-β by using Quantitative Real time PCR
9
Description
Cytokine: IL-17
Timepoint
Before interference and six months after interference
Method of measurement
Examined the expression levels of IL-17 by using Quantitative Real time PCR
10
Description
Cytokine: TGF-β
Timepoint
Before interference and six months after interference
Method of measurement
Examined the amount of secreted cytokine TGF-β by using sandwich ELISA method.
11
Description
Cytokine: IL-17
Timepoint
Before interference and six months after interference
Method of measurement
Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method.
Secondary outcomes
empty
Intervention groups
1
Description
The control group received placebo capsules once a day for six months.
Category
Treatment - Drugs
2
Description
Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for six months .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Imam Reza Hospital, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Hossein Babaei
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Ph.D Of Medical Immunology / Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
Email
Yousefime@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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