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Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients.

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History
# Registration date Revision Id
2 2025-06-30, 1404/04/09 401362
1 2024-09-11, 1403/06/21 314020
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  • Protocol summary

    A clinical trial with placebo control group by parallel groups, double-blind, randomized, phase 3 on 60 patients. SPSS software was used for randomization.
    A crossover clinical trial with placebo control group by parallel groups, double-blind, randomized, phase 3 on 60 patients. SPSS software was used for randomization.
    کارآزمایی بالینی دارای گروه کنترل پلاسبو (دارونما) با گروه های موازی ،دو سویه کور تصادفی شده، فاز 3 بر روی 60 بیمار .برای تصادفی سازی از نرم افزار SPSS استفاده شد.
    یک کارآزمایی بالینی متقاطع (crossover) دارای گروه کنترل پلاسبو (دارونما) با گروه های موازی ،دو سویه کور تصادفی شده، فاز 3 بر روی 60 بیمار .برای تصادفی سازی از نرم افزار SPSS استفاده شد.
    Inclusion criteria: Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis; Calprotectin and CRP positive; Adult patients from 18 years to 65 years; No use of other medicinal plants in the past 3 months; No allergy to saffron plant and its derivatives; Not taking new antidepressants and sleeping pills in the last 2 months; No use of new anti-inflammatory and antioxidant drugs in the last 3 months; Taking the usual medications prescribed by the doctor in the last 4 months. Exclusion criteria: Normal calprotectin and CRP; Pregnancy or breastfeeding; In case of any side effects; Anticoagulant and warfarin use; A history of other underlying diseases and autoimmune diseases; alcohol consumption.
    Inclusion criteria: Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis; positive Calprotectin; Adult patients from 18 years to 65 years; No use of other medicinal plants in the past 3 months; No allergy to saffron plant and its derivatives; Not taking new antidepressants and sleeping pills in the last 2 months; No use of new anti-inflammatory and antioxidant drugs in the last 3 months; Taking the usual medications prescribed by the doctor in the last 4 months. Exclusion criteria: Normal calprotectin ; Pregnancy or breastfeeding; In case of any side effects; Anticoagulant and warfarin use; A history of other underlying diseases and autoimmune diseases; alcohol consumption.
    شرایط ورود:بیماران مبتلا به کولیت اولسراتیو اثبات شده از طریق تشخیص بالینی و نتایج کولونوسکوپی قبلی با کولیت خفیف تا متوسط کالپروتکتین و CRP مثبت؛ بیماران بالغ 18 سال تا 65 سال؛ عدم مصرف سایر گیاهان دارویی در 3 ماه گذشته؛ نداشتن حساسیت به گیاه زعفران و مشتقات آن؛ عدم مصرف داروهای ضدافسردگی و داروهای خواب جدید در 2 ماه گذشته؛ عدم مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته؛مصرف داروهای معمول تجویز شده طبق نظر پزشک در 4 ماه گذشته. شرایط عدم ورود:کالپروتکتین و CRP نرمال ؛ بارداری و یا شیردهی؛ در صورت بروز هر گونه عوارض ناخواسته؛مصرف داروهای ضدانعقاد و وارفارین؛ سابقه ابتلا به بیماری‌های زمینه ای و بیماری‌های اتوایمیون دیگر؛ مصرف الکل.
    شرایط ورود:بیماران مبتلا به کولیت اولسراتیو اثبات شده از طریق تشخیص بالینی و نتایج کولونوسکوپی قبلی با کولیت خفیف تا متوسط کالپروتکتین مثبت؛ بیماران بالغ 18 سال تا 65 سال؛ عدم مصرف سایر گیاهان دارویی در 3 ماه گذشته؛ نداشتن حساسیت به گیاه زعفران و مشتقات آن؛ عدم مصرف داروهای ضدافسردگی و داروهای خواب جدید در 2 ماه گذشته؛ عدم مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته؛مصرف داروهای معمول تجویز شده طبق نظر پزشک در 4 ماه گذشته. شرایط عدم ورود:کالپروتکتین نرمال ؛ بارداری و یا شیردهی؛ در صورت بروز هر گونه عوارض ناخواسته؛مصرف داروهای ضدانعقاد و وارفارین؛ سابقه ابتلا به بیماری‌های زمینه ای و بیماری‌های اتوایمیون دیگر؛ مصرف الکل.
    (calprotectin، NO،CRP، MPO،TNFα،IL-6،IL-1ß)؛(MDA، CAT، TAC)؛ (AMPK، SIRT-1، GLUT1، PKM2 )؛(TG-CHOL-HDL-LDL)؛CBCdiff؛Clinical symptoms
    (calprotectin، NO،CRP، MPO،TNFα،IL-6،IL-1ß)؛(MDA،CAT، TAC, TOS,GSH)؛ (AMPK، SIRT-1، GLUT1، PKM2 )؛TG-CHOL-HDL-LDL؛CBCdiff؛Clinical symptoms;The fatty acid profile of RBC membranes;MCP-1;FBS;ALT,AST,ALP
    پارامترهای (کالپروتکتین،CRP؛ MPO؛NO ؛TNFα،IL-6،IL-1ß)؛ (AMPK SIRT-1، GLUT1، PKM2)؛( MDA، CAT، TAC)؛ (TG-CHOL-HDL-LDL) و CBC diff. علائم بالینی بیماران مبتلا به کولیت اولسراتیو
    پارامترهای (کالپروتکتین،CRP؛ MPO؛NO ؛TNFα،IL-6،IL-1ß)؛ (AMPK SIRT-1، GLUT1، PKM2)؛( GSH, MDA، CAT، TAC,TOS)؛ (TG-CHOL-HDL-LDL) و CBC diff. علائم بالینی بیماران مبتلا به کولیت اولسراتیو؛ پروفایل اسیدهای چرب غشا گلبولهای قرمز؛ MCP-1؛ FBS; آنزیم های کبدی AST,ALT,ALP

  • General information

    Parallel
    Crossover
    60
    30
    No
    Yes
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    4
    2024-10-06, 1403/07/15
    2025-02-18, 1403/11/30
    2025-10-07, 1404/07/15
    2026-12-21, 1405/09/30
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    Changes to the study design and the addition of a measurable outcome variable
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    تغییرات اعمال شده در نوع مطالعه و افزدوده شدن متغییر پیامد قابل اندازه گیری
    Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis
    Calprotectin and CRP positive and receiving standard treatment of mesalamine
    Adult patients from 18 years to 65 years.
    No use of other medicinal plants in the past 3 months.
    No allergy to saffron plant and its derivatives.
    Not taking new antidepressants and sleeping pills in the last 2 months.
    No use of new anti-inflammatory and antioxidant drugs in the last 3 months.
    Taking the usual medications prescribed by the doctor in the last 4 months.
    Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis
    positive Calprotectin and receiving standard treatment of mesalamine
    Adult patients from 18 years to 65 years.
    No use of other medicinal plants in the past 3 months.
    No allergy to saffron plant and its derivatives.
    Not taking new antidepressants and sleeping pills in the last 2 months.
    No use of new anti-inflammatory and antioxidant drugs in the last 3 months.
    Taking the usual medications prescribed by the doctor in the last 4 months.
    بیماران مبتلا به کولیت اولسراتیو اثبات شده از طریق تشخیص بالینی و نتایج کولونوسکوپی قبلی با کولیت خفیف تا متوسط
    کالپروتکتین و CRP مثبت و دریافت کننده درمان استاندارد مزالامین
    بیماران بالغ 18 سال تا 65 سال.
    عدم مصرف سایر گیاهان دارویی در 3 ماه گذشته.
    نداشتن حساسیت به گیاه زعفران و مشتقات آن .
    عدم مصرف داروهای ضدافسردگی و داروهای خواب جدید در 2 ماه گذشته.
    عدم مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته.
    مصرف داروهای معمول تجویز شده طبق نظر پزشک در 4 ماه گذشته.
    بیماران مبتلا به کولیت اولسراتیو اثبات شده از طریق تشخیص بالینی و نتایج کولونوسکوپی قبلی با کولیت خفیف تا متوسط
    کالپروتکتین مثبت و دریافت کننده درمان استاندارد مزالامین
    بیماران بالغ 18 سال تا 65 سال.
    عدم مصرف سایر گیاهان دارویی در 3 ماه گذشته.
    نداشتن حساسیت به گیاه زعفران و مشتقات آن .
    عدم مصرف داروهای ضدافسردگی و داروهای خواب جدید در 2 ماه گذشته.
    عدم مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته.
    مصرف داروهای معمول تجویز شده طبق نظر پزشک در 4 ماه گذشته.
    Normal calprotectin and CRP.
    Pregnancy or breastfeeding.
    In case of any side effects.
    Anticoagulant and warfarin use.
    A history of other underlying diseases and autoimmune diseases.
    alcohol consumption
    Taking any anti-depressant, anti-inflammatory and new sleep medications in the last 2 months.
    Consumption of new anti-inflammatory and antioxidant drugs in the last 3 months.
    Change in commonly prescribed medications in the last 4 months.
    Normal calprotectin
    Pregnancy or breastfeeding.
    In case of any side effects.
    Anticoagulant and warfarin use.
    A history of other underlying diseases and autoimmune diseases.
    alcohol consumption
    Taking any anti-depressant, anti-inflammatory and new sleep medications in the last 2 months.
    Consumption of new anti-inflammatory and antioxidant drugs in the last 3 months.
    Change in commonly prescribed medications in the last 4 months.
    کالپروتکتین و CRP نرمال .
    بارداری و یا شیردهی.
    در صورت بروز هر گونه عوارض ناخواسته.
    مصرف داروهای ضدانعقاد و وارفارین.
    سابقه ابتلا به بیماری‌های زمینه ای و بیماری‌های اتوایمیون دیگر.
    مصرف الکل
    مصرف هر گونه داروی ضدافسردگی، ضدالتهابی و داروهای خواب جدید در 2 ماه گذشته.
    مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته.
    تغییر در داروهای تجویز شده معمول در 4 ماه گذشته.
    کالپروتکتین نرمال .
    بارداری و یا شیردهی.
    در صورت بروز هر گونه عوارض ناخواسته.
    مصرف داروهای ضدانعقاد و وارفارین.
    سابقه ابتلا به بیماری‌های زمینه ای و بیماری‌های اتوایمیون دیگر.
    مصرف الکل
    مصرف هر گونه داروی ضدافسردگی، ضدالتهابی و داروهای خواب جدید در 2 ماه گذشته.
    مصرف داروهای ضدالتهابی و آنتی اکسیدانی جدید در 3 ماه گذشته.
    تغییر در داروهای تجویز شده معمول در 4 ماه گذشته.
    60 patients with ulcerative colitis who are under standard treatment with mesalamine are selected. Randomization of samples is based on block randomization method. For random assignment with random numbers generated by SPSS software (use of random blocks with a volume of 4), each patient is assigned a code and then according to the treatment group assigned to the corresponding code, the patient is in one of the intervention groups to receive crocin or The control received a placebo.
    30 patients with ulcerative colitis who are under standard treatment with mesalamine are selected. Randomization of samples is based on block randomization method. For random assignment with random numbers generated by SPSS software (use of random blocks with a volume of 6), each patient is assigned a code and then according to the treatment group assigned to the corresponding code, the patient is in one of the intervention groups to receive crocin or The control received a placebo.
    60 بیمار مبتلا به کولیت اولسراتیو که تحت درمان استاندارد با مزالامین هستند انتخاب میشوند. تصادفی سازی نمونه ها بر اساس روش تصادفی سازی بلوک (Block randomization) می باشد. برای تخصیص تصادفی با اعداد تصادفی تولید شده با نرم افزار SPSS (استفاده از بلوک های تصادفی به حجم 4) به هر بیمار یک کد اختصاص یافته و سپس بنابر گروه درمانی تخصیص یافته به کد مربوطه ، بیمار دریکی از گروه های مداخله جهت دریافت کروسین یا کنترل دریافت کننده پلاسبو قرار می گیرند.
    30 بیمار مبتلا به کولیت اولسراتیو که تحت درمان استاندارد با مزالامین هستند انتخاب میشوند. تصادفی سازی نمونه ها بر اساس روش تصادفی سازی بلوک (Block randomization) می باشد. برای تخصیص تصادفی با اعداد تصادفی تولید شده با نرم افزار SPSS (استفاده از بلوک های تصادفی به حجم 6) به هر بیمار یک کد اختصاص یافته و سپس بنابر گروه درمانی تخصیص یافته به کد مربوطه ، بیمار دریکی از گروه های مداخله جهت دریافت کروسین یا کنترل دریافت کننده پلاسبو قرار می گیرند.
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    According to the 2×2 crossover design, each participant will undergo two consecutive treatment periods, with a 3-week washout period between the two periods. In each period, two samples will be collected: one before the intervention (Baseline) and one after the intervention (Post-treatment). Therefore, a total of 4 samples will be collected from each individual (2 periods × 2 samples per period).
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    با توجه به طراحی متقاطع ۲×۲، هر شرکت‌کننده در دو دوره درمانی متوالی قرار می‌گیرد و بین دو دوره یک دوره پاکسازی (Washout) به مدت ۳ هفته در نظر گرفته شده است. در هر دوره، دو بار نمونه‌گیری انجام می‌شود: یک نمونه قبل از مداخله (Baseline) و یک نمونه بعد از مداخله (Post-treatment). بنابراین، از هر فرد در مجموع ۴ نمونه گرفته می‌شود (۲ دوره × ۲ نمونه‌گیری در هر دوره).

  • Ethics committees

    #1
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    2025-06-07, 1404/03/17
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    IR.MUI.PHANUT.REC.1404.027

  • Primary outcomes

    #1
    Ulcerative colitis disease activity index in the Mayo clinic score questionnaire
    Ulcerative colitis disease activity index
    شاخص فعالیت بیماری کولیت اولسراتیو در پرسشنامه Mayo clinic score
    شاخص فعالیت بیماری کولیت اولسراتیو
    Mayo clinic score questionnaire
    Truelove and Witts' classification
    نمره پرسشنامه Mayo clinic score
    طبقه بندی Truelove and Witts

  • Secondary outcomes

    #1
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    The fatty acid profile of erythrocyte membranes
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    پروفایل اسیدهای چرب غشای گلبولهای قرمز
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Gas Chromatography
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    کروماتوگرافی گازی
    #2
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    Monocyte Chemoattractant Protein-1 (MCP-1)
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    پروتئین کوتاکتیک مونوسیت (MCP-1)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    ELISA
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    الایزا
    #3
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    Total Oxidant Capacity (TOS)
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    ظرفیت تام اکسیدانی (TOS)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #4
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    Glutathione(GSH)
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    گلوتاتیون (GSH)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #5
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    Fasting Blood Sugar (FBS)
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    قند خون ناشتا (FBS)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #6
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    Alanine Aminotransferase (ALT)
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    آلانین آمینوترانسفراز (ALT)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Enzymatic kit
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    کیت آنزیماتیک
    #7
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    Aspartate Aminotransferase (AST)
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    آسپارتات آمینوترانسفراز (AST)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Enzymatic kit
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    کیت آنزیماتیک
    #8
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    Alkaline phosphatase (ALP)
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    آلکالین فسفاتاز (ALP)
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    Before the intervention and 12 weeks after the intervention
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    قبل از شروع مداخله و 12 هفته بعد از شروع مداخله
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    Enzymatic kit
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    کیت آنزیمی

  • Intervention groups

    #1
    Control group: Patients receiving standard treatment of mesalamine plus two placebo capsules containing starch daily for 12 weeks. The placebo will be completely similar to the crocin supplement in terms of shape and appearance of the package.
    Control group: Patients receiving standard treatment of mesalamine plus two placebo capsules containing starch daily for 12 weeks. The placebo will be completely similar to the crocin supplement in terms of shape and appearance of the package. Following a 21-day (3-week) wash-out period during which crocin and placebo are discontinued, the treatments are crossed over: the group previously receiving crocin is administered placebo, and the group previously receiving placebo is administered crocin.
    گروه کنترل: بیماران دریافت کننده درمان استاندارد مزالامین بعلاوه روزانه دو عدد کپسول پلاسبو حاوي نشاسته را به مدت 12 هفته. پلاسبو از نظر شکل و ظاهر بسته بندی کاملا مشابه مکمل کروسین می باشد.
    گروه کنترل: بیماران دریافت کننده درمان استاندارد مزالامین بعلاوه روزانه دو عدد کپسول پلاسبو حاوي نشاسته را به مدت 12 هفته. پلاسبو از نظر شکل و ظاهر بسته بندی کاملا مشابه مکمل کروسین می باشد.سپس به مدت 21 روز (3 هفته) کروسین و دارونما قطع میشود (wash-out period) پس از این مدت به گروه دریافت کننده کروسین، دارونما و به گروه دریافت کننده دارونما، کروسین داده میشود

  • Recruitment centers

    #1
    Name of recruitment center - English: مرکز تحقیقات و کلینیک بیماری های گوارش پورسینای حکیم
    Name of recruitment center - Persian: Poursina Hakim Digestive Disease Research Center
    Full name of responsible person - English: Dr. Seyed Mohammad Hassan Emami
    Full name of responsible person - Persian: دکتر سید محمد حسن امامی
    Street address - English: Level 3, Building No. 1, PoursinaHakim Digestive Disease Research Center,Isfahan Healthcare City, Aghababaei Expy Isfahan
    Street address - Persian: اتوبان آقابابایی، خیابان سپهر، شهرک سلامت اصفهان، طبقه سوم،;مرکز تحقیقات پورسینای حکیم
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8198314287
    Phone: +98 31 3554 8151
    Fax:
    Email: pddrc.com@gmail.com
    Web page address:
    Name of recruitment center - English: Poursina Hakim Digestive Disease Research Center
    Name of recruitment center - Persian: مرکز تحقیقات و کلینیک بیماری های گوارش پورسینای حکیم
    Full name of responsible person - English: Dr. Seyed Mohammad Hassan Emami
    Full name of responsible person - Persian: دکتر سید محمد حسن امامی
    Street address - English: Level 3, Building No. 1, PoursinaHakim Digestive Disease Research Center,Isfahan Healthcare City, Aghababaei Expy Isfahan
    Street address - Persian: اتوبان آقابابایی، خیابان سپهر، شهرک سلامت اصفهان، طبقه سوم،;مرکز تحقیقات پورسینای حکیم
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8198314287
    Phone: +98 31 3554 8151
    Fax:
    Email: pddrc.com@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر غلامرضا عسگری
    Full name of responsible person - Persian: Dr. Gholamreza Asgari
    Street address - English: Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave.
    Street address - Persian: خیابان هزار جریب،دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان ،ساختمان شماره 4، معاونت تحقیقات و فناوری
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 8138
    Fax:
    Email: research@mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Gholamreza Asgari
    Full name of responsible person - Persian: دکتر غلامرضا عسگری
    Street address - English: Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave.
    Street address - Persian: خیابان هزار جریب،دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان ،ساختمان شماره 4، معاونت تحقیقات و فناوری
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 8138
    Fax:
    Email: research@mui.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shima Kabiri Arani
    Full name of responsible person - Persian: شیما کبیری ارانی
    Position - English: .ph.D student
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: master
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
    Street address - Persian: میدان آزادی، خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان، دانشکده داروسازی و علوم دارویی، گروه بیوشیمی بالینی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673441
    Phone: +98 31 3792 7052
    Mobile: +98 913 306 3597
    Fax:
    Email: sh_kabiri@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad hosein Aarabi
    Full name of responsible person - Persian: محمد حسین اعرابی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
    Street address - Persian: میدان آزادی، خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان، دانشکده داروسازی و علوم دارویی، گروه بیوشیمی بالینی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673441
    Phone: +98 31 3792 7052
    Mobile: +98 913 329 9420
    Fax:
    Email: mh.aarabi@pharm.mui.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Hossein Aarabi
    Full name of responsible person - Persian: محمدحسین اعرابی
    Position - English: Professor of Clinical Biochemistry
    Position - Persian: استاد تمام بیوشیمی بالینی
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
    Street address - Persian: میدان آزادی، خیابان هزار جریب, دانشگاه علوم پزشکی اصفهان, دانشکده داروسازی و علوم دارویی, گروه بیوشیمی بالینی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673441
    Phone: +98 31 3792 7052
    Mobile: +98 913 329 9420
    Fax:
    Email: mh.aarabi@pharm.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Hossein Aarabi
    Full name of responsible person - Persian: محمدحسین اعرابی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
    Street address - Persian: میدان آزادی، خیابان هزار جریب, دانشگاه علوم پزشکی اصفهان, دانشکده داروسازی و علوم دارویی, گروه بیوشیمی بالینی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673441
    Phone: +98 31 3792 7052
    Mobile: +98 913 329 9420
    Fax:
    Email: mh.aarabi@pharm.mui.ac.ir
    Web page address:

Protocol summary

Study aim
Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients receiving crocin compared with the group receiving placebo before and after the study.
Design
A crossover clinical trial with placebo control group by parallel groups, double-blind, randomized, phase 3 on 60 patients. SPSS software was used for randomization.
Settings and conduct
Place of study: Porcine Hakim, Gastrointestinal and Liver Diseases Clinic, Isfahan; Study population: Adults with ulcerative colitis 18 to 65 years; Type of blinding: Double-blind including patients and researchers; Method of blinding: Through codes designed with SPSS by a third party
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis; positive Calprotectin; Adult patients from 18 years to 65 years; No use of other medicinal plants in the past 3 months; No allergy to saffron plant and its derivatives; Not taking new antidepressants and sleeping pills in the last 2 months; No use of new anti-inflammatory and antioxidant drugs in the last 3 months; Taking the usual medications prescribed by the doctor in the last 4 months. Exclusion criteria: Normal calprotectin ; Pregnancy or breastfeeding; In case of any side effects; Anticoagulant and warfarin use; A history of other underlying diseases and autoimmune diseases; alcohol consumption.
Intervention groups
Intervention group: recipient of mesalamine with 15 mg of crocin twice daily Control group: receiving mesalamine with placebo containing starch twice a day
Main outcome variables
(calprotectin، NO،CRP، MPO،TNFα،IL-6،IL-1ß)؛(MDA،CAT، TAC, TOS,GSH)؛ (AMPK، SIRT-1، GLUT1، PKM2 )؛TG-CHOL-HDL-LDL؛CBCdiff؛Clinical symptoms;The fatty acid profile of RBC membranes;MCP-1;FBS;ALT,AST,ALP

General information

Reason for update
Changes to the study design and the addition of a measurable outcome variable
Acronym
IRCT registration information
IRCT registration number: IRCT20240831062917N1
Registration date: 2024-09-11, 1403/06/21
Registration timing: prospective

Last update: 2026-10-28, 1405/08/06
Update count: 1
Registration date
2024-09-11, 1403/06/21
Registrant information
Name
Shima Kabiri Arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7052
Email address
sh_kabiri@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-18, 1403/11/30
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients.
Public title
Investigating the effect of crocin in ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis positive Calprotectin and receiving standard treatment of mesalamine Adult patients from 18 years to 65 years. No use of other medicinal plants in the past 3 months. No allergy to saffron plant and its derivatives. Not taking new antidepressants and sleeping pills in the last 2 months. No use of new anti-inflammatory and antioxidant drugs in the last 3 months. Taking the usual medications prescribed by the doctor in the last 4 months.
Exclusion criteria:
Normal calprotectin Pregnancy or breastfeeding. In case of any side effects. Anticoagulant and warfarin use. A history of other underlying diseases and autoimmune diseases. alcohol consumption Taking any anti-depressant, anti-inflammatory and new sleep medications in the last 2 months. Consumption of new anti-inflammatory and antioxidant drugs in the last 3 months. Change in commonly prescribed medications in the last 4 months.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 4
According to the 2×2 crossover design, each participant will undergo two consecutive treatment periods, with a 3-week washout period between the two periods. In each period, two samples will be collected: one before the intervention (Baseline) and one after the intervention (Post-treatment). Therefore, a total of 4 samples will be collected from each individual (2 periods × 2 samples per period).
Randomization (investigator's opinion)
Randomized
Randomization description
30 patients with ulcerative colitis who are under standard treatment with mesalamine are selected. Randomization of samples is based on block randomization method. For random assignment with random numbers generated by SPSS software (use of random blocks with a volume of 6), each patient is assigned a code and then according to the treatment group assigned to the corresponding code, the patient is in one of the intervention groups to receive crocin or The control received a placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to conduct this research in a double-blind manner, patients, researchers, clinical caregivers, outcome assessors, and data analysts are blinded by codes designed with SPSS by a third party (a person other than the researchers). Statistical software codes consist of Latin letters A and B along with numbers. The third party assigns one of the letters A and B included in the designed codes to the crocin group and the other to the placebo group. The codes are pasted on the cans containing crocin or placebo, and based on the code written on it, it is filled by the mentioned person and given to the researcher. Finally, without knowing the contents of the cans, the researcher randomly provides them to the patients.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.059

2

Ethics committee
Name of ethics committee
Research Ethics committees of schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-06-07, 1404/03/17
Ethics committee reference number
IR.MUI.PHANUT.REC.1404.027

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Calprotectin
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
ELISA

2

Description
Nitric oxide (NO)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

3

Description
Myeloperoxidase (MPO)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

4

Description
Quantitative CRP
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Turbidimetry

5

Description
Catalase
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

6

Description
Malondialdehyde (MDA)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

7

Description
Total antioxidant capacity (TAC)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

8

Description
AMPK gen expression
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Real-time PCR

9

Description
SIRT-1 gen expression
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Real-time PCR

10

Description
GLUT1 gen expression
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Real-time PCR

11

Description
PKM2 gen expression
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Real-time PCR

12

Description
TNFα
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
ELISA

13

Description
IL-6
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
ELISA

14

Description
IL-1ß
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
ELISA

15

Description
Ulcerative colitis disease activity index
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Truelove and Witts' classification

16

Description
Cell Blood Count. diff.
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Hematology cell counter

Secondary outcomes

1

Description
Quality of life in ulcerative colitis
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
32-question IBD Quality of life questionnaire ( IBD Q-32 )

2

Description
Triglycerides (TG)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
spectrophotometry

3

Description
Total cholesterol
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
spectrophotometry

4

Description
HDL-Cholesterols
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
spectrophotometry

5

Description
LDL-Cholesterol
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

6

Description
The fatty acid profile of erythrocyte membranes
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Gas Chromatography

7

Description
Monocyte Chemoattractant Protein-1 (MCP-1)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
ELISA

8

Description
Total Oxidant Capacity (TOS)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

9

Description
Glutathione(GSH)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

10

Description
Fasting Blood Sugar (FBS)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Spectrophotometry

11

Description
Alanine Aminotransferase (ALT)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic kit

12

Description
Aspartate Aminotransferase (AST)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic kit

13

Description
Alkaline phosphatase (ALP)
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Patients receiving the standard treatment of mesalamine plus two daily capsules of crocin (Samisaz company) for 12 weeks, orally, each containing 15 mg of crocin supplement.
Category
Treatment - Drugs

2

Description
Control group: Patients receiving standard treatment of mesalamine plus two placebo capsules containing starch daily for 12 weeks. The placebo will be completely similar to the crocin supplement in terms of shape and appearance of the package. Following a 21-day (3-week) wash-out period during which crocin and placebo are discontinued, the treatments are crossed over: the group previously receiving crocin is administered placebo, and the group previously receiving placebo is administered crocin.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hakim Digestive Disease Research Center
Full name of responsible person
Dr. Seyed Mohammad Hassan Emami
Street address
Level 3, Building No. 1, PoursinaHakim Digestive Disease Research Center,Isfahan Healthcare City, Aghababaei Expy Isfahan
City
Isfahan
Province
Isfehan
Postal code
8198314287
Phone
+98 31 3554 8151
Email
pddrc.com@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hosein Aarabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Fax
Email
mh.aarabi@pharm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Aarabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Email
mh.aarabi@pharm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shima Kabiri Arani
Position
.ph.D student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Fax
Email
sh_kabiri@yahoo.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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