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Evaluating the effects of the traditional wheat product (saviq) on the pattern of changes caused bychemotherapy in the gastrointestinal tract of children with acute lymphoblastic leukemia referred to the Imam Rezaclinic in 1401 - a triple-blind clinical trial

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History
# Registration date Revision Id
2 2023-09-05, 1402/06/14 278754
1 2022-05-24, 1401/03/03 227432
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  • Protocol summary

    Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 80 patients. For randomization in this study, the Restricted randomization method of block randomization has been used.
    Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 58 patients. For randomization in this study, the Restricted randomization method of block randomization has been used.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 80 بیمار. برای تصادفی سازی در این پژوهش از روش تصادفی سازی محدود تصادفی سازی بلوکی استفاده شده است.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 58 بیمار. برای تصادفی سازی در این پژوهش از روش تصادفی سازی محدود تصادفی سازی بلوکی استفاده شده است.

  • General information

    80
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    2022-06-07, 1401/03/17
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    2023-06-10, 1402/03/20
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    2023-06-10, 1402/03/20
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    Correcting the sample size based on the correct and realistic criteria and announcing the end of sampling (The size of the initial sample was not based on realistic formulas and criteria, and due to the limitation in the number and low cooperation of children and parents in the cancer department, it was necessary to revise and correct it. Due to the special conditions and the limitation of the number of children with entry conditions To study, the previously mentioned number was somehow not possible.) Modified sample volume formula: In order to compare the average of the intended outcomes between the two sample size groups, taking into account the type 1 error and the power equal to 5 and 80% and the effect size equal to 0.8 (based on Cohen's criterion and due to the lack of a similar study in the studied population, i.e. children with leukemia) equal to 52 people (26 people in each group) was calculated using GPower software. Therefore, taking into account the dropout error equal to 10%, the final sample volume was determined to be 58 people (29 people in each group).
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    اصلاح حجم نمونه بر اساس معیار صحیح و واقع گرایانه اعلام پایان نمونه گیری (حجم نمونه اولیه بر اساس فرمول و معیارهای واقع گرایانه نبوده است و با توجه به محدودیت موجود در تعداد و همکاری کم کودکان و والدین در بخش سرطان، نیاز به بازنگری و تصحیح بود. با توجه به شرایط خاص و محدودیت تعداد کودکان دارای شرایط ورود به مطالعه، تعداد مذکور قبلی به نوعی امکان پذیر نبود.) فرمول حجم نمونه اصلاح شده: جهت مقایسه میانگین پیامدهای مورد نظر بین دو گروه حجم نمونه با در نظر گرفتن خطای نوع اول و توان برابر با ۵ و ۸۰ درصد و اندازه اثر برابر با ۸/۰ (بر اساس معیار کوهن و بدلیل موجود نبودن مطالعه مشابه در جمعیت مورد بررسی یعنی کودکان دارای لوکمی) برابر با ۵۲ نفر (۲۶ نفر در هر گروه) با استفاده از نرم افزار GPower محاسبه گردید. لذا با در نظر گرفتن خطای ریزش برابر با ۱۰ درصد حجم نمونه نهایی برابر با ۵۸ نفر (۲۹ نفر در هر گروه) تعیین گردید.

  • Secondary outcomes

    #1
    "Quality of life" of children - "Weight" of the child - "Daily fever" of the child - "Blood test (CBC)" - "Gastrointestinal microbiome" - "Number of colonies created by the collection of bacteria in the feces"
    "Quality of life" of children - "Weight" of the child - "Blood test (CBC)" - "Gastrointestinal microbiome" - "Number of colonies created by the collection of bacteria in the feces"
    "کیفیت زندگی" کودکان - "وزن" کودک - "میزان تب روزانه" کودک - "آزمایش خون(CBC)" - "میکروبیوم گوارشی" - "تعداد کلونی های ایجاد شده توسط مجموعه باکتری های موجود در مدفوع"
    "کیفیت زندگی" کودکان - "وزن" کودک - "آزمایش خون(CBC)" - "میکروبیوم گوارشی" - "تعداد کلونی های ایجاد شده توسط مجموعه باکتری های موجود در مدفوع"
    TAPQOL Quality of Life Questionnaire for Preschool Children (1-6 years old) and PedsQL Questionnaire for Quality of Life of Preschool Children- "Weight" of the child on day 0 and day 28 after the intervention"Blood test (CBC)" to check for blood factors including WBC Plt Hb RBC on day 0 and day 28 after intervention - as well as recording the child's "daily fever chart"- "Stool test" of the child and performing Real-Time PCR to measure and determine the gastrointestinal microbiome on day 0 and day 28 after the intervention- Counting the number of colonies created by the collection of bacteria in the feces by microdilution culture on day 0 and 28 of the intervention
    TAPQOL Quality of Life Questionnaire for Preschool Children (1-6 years old) and PedsQL Questionnaire for Quality of Life of Preschool Children- "Weight" of the child on day 0 and day 28 after the intervention"Blood test (CBC)" to check for blood factors including WBC Plt Hb RBC on day 0 and day 28 after intervention - "Stool test" of the child and performing Real-Time PCR to measure and determine the gastrointestinal microbiome on day 0 and day 28 after the intervention- Counting the number of colonies created by the collection of bacteria in the feces by microdilution culture on day 0 and 28 of the intervention
    پرسشنامه کیفیت زندگی کودکان پیش از دبستان (1-6سال) TAPQOL و پرسشنامه "کیفیت زندگی" کودکان پس از دبستان PedsQL - "وزن" کودک روز صفر و روز 28 بعد از مداخله - "آزمایش خون(CBC)" جهت بررسی فاکتورهای خونی شامل WBC Plt Hb RBC روز صفر و روز 28 بعد از مداخله- و همچنین ثبت "چارت تب روزانه" کودک - "آزمایش مدفوع" کودک و انجام Real-Time PCR جهت اندازه گیری و تعیین میکروبیوم گوارشی روز صفر و روز 28 بعد از مداخله - شمارش تعداد کلونی های ایجاد شده توسط مجموعه باکتری های موجود در مدفوع بصورت کشت میکرودایلیشن در روز صفر و 28 مداخله
    پرسشنامه کیفیت زندگی کودکان پیش از دبستان (1-6سال) TAPQOL و پرسشنامه "کیفیت زندگی" کودکان پس از دبستان PedsQL - "وزن" کودک روز صفر و روز 28 بعد از مداخله - "آزمایش خون(CBC)" جهت بررسی فاکتورهای خونی شامل WBC Plt Hb RBC روز صفر و روز 28 بعد از مداخله "آزمایش مدفوع" کودک و انجام Real-Time PCR جهت اندازه گیری و تعیین میکروبیوم گوارشی روز صفر و روز 28 بعد از مداخله - شمارش تعداد کلونی های ایجاد شده توسط مجموعه باکتری های موجود در مدفوع بصورت کشت میکرودایلیشن در روز صفر و 28 مداخله

  • Intervention groups

    #1
    Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The product is given to the mother in the form of powder in ready-made aluminum packages and the recipe is as follows: mix with boiling water and add Jollab syrup (which is given to the mother along with medicine sachets) and cook it briefly until it becomes halva. Jollab syrup (a combination of rose, saffron and sugar) is delivered to the mother ready with sachets containing soybean. The method of combining suviq and jollab will be explained to the mother both in writing and orally.Remove the resulting mixture from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, according to the dose of saviq.A short video of the work process was also sent to them. Product: Whole wheat saviq with jollab syrup - Jollab syrup preparation formula: three liters of rose water per kilogram of sugar + half a pound of saffron (about two grams) _ daily consumption of children depending on their age and weight between 20-30 grams Saviq. The jollab syrup is purchased from a pharmaceutical company and saviq is produced by the pharmacist of the study.
    Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The product is given to the mother in the form of powder and the recipe is as follows: mix with boiling water and add Jollab syrup (which is given to the mother along with medicine sachets) and cook it briefly until it becomes halva. Jollab syrup (a combination of rose, saffron and sugar) is delivered to the mother ready with sachets containing soybean. The method of combining suviq and jollab will be explained to the mother both in writing and orally.Remove the resulting mixture from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, according to the dose of saviq.A short video of the work process was also sent to them. Product: Whole wheat saviq with jollab syrup - Jollab syrup preparation formula: three liters of rose water per kilogram of sugar + half a pound of saffron (about two grams) _ daily consumption of children depending on their age and weight between 20-30 grams Saviq. The jollab syrup is purchased from a pharmaceutical company and saviq is produced by the pharmacist of the study.
    گروه مداخله: فراورده سنتی "سویق گندم" به عنوان "غذای مکمل" به گروه مورد داده میشود. به مدت چهار هفته و روزی یک بار باید میل شود. زمان مصرف ترکیب غذایی به صورت یک وعده در روز و ترجیحا در میان وعده ی صبح می باشد.فراورده به صورت پودر در بسته های آماده ی آلمینیومی به مادر داده می شود و دستور طبخ آن به صورت: مخلوط کردن با آب جوش و اضافه کردن شربت جلاب(که همراه ساشه های دارو/دارونما به مادر داده می شود) و طبخ مختصر آن تا حالت حلوا به خود بگیرد. شربت جلاب (ترکیب گلاب، زعفران و شکر) به صورت آماده همراه با ساشه های حاوی سویق به مادر تحویل داده می شود. شیوه ی ترکیب کردن سویق و جلاب هم به صورت مکتوب هم به صورت شفاهی به مادر توضیح داده خواهد شد.(مختصری آب راروی حرارت ملایم گذارد و دوز تعیین شده روزانه سویق را در آن میریزد تا حرارت مختصری یابد و آب تبخیر شود. ترکیب بدست آمده را از روی حرارت برداشته و پس از آنکه کمی سرد شد ، شربت را به میزان 2-3 قاشق غذاخوری، متناسب با دوز سویق به آن اضافه میکنند) یک فیلم کوتاه از مراحل کار نیز برای ایشان فرستاده خواهد شد. فرآورده: سویق آرد گندم کامل به همراه شربت جلاب - فرمول تهیه شربت جلاب: سه لیتر گلاب به ازای یک کیلو شکر + نیم مثقال زعفران (حدود دو گرم) _ میزان مصرف روزانه کودکان به توجه به سن و وزن آنها بین 20-30 گرم سویق روزانه می باشد. جلاب مصرف شده در مطالعه از شرکت دارویی خریداری میشود و سویق مصرفی توسط داروساز مطالعه تولید میشود.
    گروه مداخله: فراورده سنتی "سویق گندم" به عنوان "غذای مکمل" به گروه مورد داده میشود. به مدت چهار هفته و روزی یک بار باید میل شود. زمان مصرف ترکیب غذایی به صورت یک وعده در روز و ترجیحا در میان وعده ی صبح می باشد.فراورده به صورت پودر به مادر داده می شود و دستور طبخ آن به صورت: مخلوط کردن با آب جوش و اضافه کردن شربت جلاب(که همراه ساشه های دارو/دارونما به مادر داده می شود) و طبخ مختصر آن تا حالت حلوا به خود بگیرد. شربت جلاب (ترکیب گلاب، زعفران و شکر) به صورت آماده همراه با ساشه های حاوی سویق به مادر تحویل داده می شود. شیوه ی ترکیب کردن سویق و جلاب هم به صورت مکتوب هم به صورت شفاهی به مادر توضیح داده خواهد شد.(مختصری آب راروی حرارت ملایم گذارد و دوز تعیین شده روزانه سویق را در آن میریزد تا حرارت مختصری یابد و آب تبخیر شود. ترکیب بدست آمده را از روی حرارت برداشته و پس از آنکه کمی سرد شد ، شربت را به میزان 2-3 قاشق غذاخوری، متناسب با دوز سویق به آن اضافه میکنند) یک فیلم کوتاه از مراحل کار نیز برای ایشان فرستاده خواهد شد. فرآورده: سویق آرد گندم کامل به همراه شربت جلاب - فرمول تهیه شربت جلاب: سه لیتر گلاب به ازای یک کیلو شکر + نیم مثقال زعفران (حدود دو گرم) _ میزان مصرف روزانه کودکان به توجه به سن و وزن آنها بین 20-30 گرم سویق روزانه می باشد. جلاب مصرف شده در مطالعه از شرکت دارویی خریداری میشود و سویق مصرفی توسط داروساز مطالعه تولید میشود.
    #2
    "Refined wheat flour" is given to the control group as a placebo. It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The placebo is given to the mother in the form of powder in ready-made aluminum packages and the recipe is as follows: Placebo syrup (which is given to the mother along with placebo sachets) and cook it briefly until it becomes halva. In the placebo group, a syrup with the same color, taste and aroma of jalab is given, which is without rose and saffron and contains only a small amount of essential oil. The method of mixing flour and syrup will also be explained to the mother in writing orally. Remove from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, depending on the dose of flour) (a short video of the steps will be sent to them. The daily consumption of children, depending on their age and weight, is between 20-30 grams per day. The syrup used in the study is purchased from a pharmaceutical company and the consumed flour is purchased from a specific brand in the market.
    "Refined wheat flour" is given to the control group as a placebo. It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The placebo is given to the mother in the form of powder and the recipe is as follows: Placebo syrup (which is given to the mother along with placebo sachets) and cook it briefly until it becomes halva. In the placebo group, a syrup with the same color, taste and aroma of jalab is given, which is without rose and saffron and contains only a small amount of essential oil. The method of mixing flour and syrup will also be explained to the mother in writing orally. Remove from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, depending on the dose of flour) (a short video of the steps will be sent to them. The daily consumption of children, depending on their age and weight, is between 20-30 grams per day. The syrup used in the study is purchased from a pharmaceutical company and the consumed flour is purchased from a specific brand in the market.
    "آرد گندم تصفیه شده" به عنوان "پلاسبو" به گروه شاهد داده میشود. به مدت چهار هفته و روزی یک بار باید میل شود. زمان مصرف ترکیب غذایی به صورت یک وعده در روز و ترجیحا در میان وعده ی صبح می باشد.دارونما به صورت پودر در بسته های آماده ی آلمینیومی به مادر داده می شود و دستور طبخ آن به صورت: مخلوط کردن با آب جوش و اضافه کردن شربت پلاسبو(که همراه ساشه های دارونما به مادر داده می شود) و طبخ مختصر آن تا حالت حلوا به خود بگیرد. در گروه پلاسبو شربتی با رنگ و طعم و عطر مشابه جلاب که بدون گلاب و زعفران و تنها حاوی اسانس مختصری از آنهاست داده می شود. شیوه ی ترکیب کردن آرد و شربت به صورت مکتوب هم به صورت شفاهی به مادر توضیح داده خواهد شد.(مختصری آب راروی حرارت ملایم گذارد و دوز تعیین شده روزانه آرد را در آن میریزد تا حرارت مختصری یابد و آب تبخیر شود. ترکیب بدست آمده را از روی حرارت برداشته و پس از آنکه کمی سرد شد ، شربت را به میزان 2-3 قاشق غذاخوری، متناسب با دوز آرد به آن اضافه میکنند) یک فیلم کوتاه از مراحل کار نیز برای ایشان فرستاده خواهد شد. میزان مصرف روزانه کودکان به توجه به سن و وزن آنها بین 20-30 گرم سویق روزانه می باشد. شربت مصرف شده در مطالعه از شرکت دارویی خریداری میشود و آرد مصرفی از یک برند بازار خریداری میشود.
    "آرد گندم تصفیه شده" به عنوان "پلاسبو" به گروه شاهد داده میشود. به مدت چهار هفته و روزی یک بار باید میل شود. زمان مصرف ترکیب غذایی به صورت یک وعده در روز و ترجیحا در میان وعده ی صبح می باشد.دارونما به صورت پودر به مادر داده می شود و دستور طبخ آن به صورت: مخلوط کردن با آب جوش و اضافه کردن شربت پلاسبو(که همراه ساشه های دارونما به مادر داده می شود) و طبخ مختصر آن تا حالت حلوا به خود بگیرد. در گروه پلاسبو شربتی با رنگ و طعم و عطر مشابه جلاب که بدون گلاب و زعفران و تنها حاوی اسانس مختصری از آنهاست داده می شود. شیوه ی ترکیب کردن آرد و شربت به صورت مکتوب هم به صورت شفاهی به مادر توضیح داده خواهد شد.(مختصری آب راروی حرارت ملایم گذارد و دوز تعیین شده روزانه آرد را در آن میریزد تا حرارت مختصری یابد و آب تبخیر شود. ترکیب بدست آمده را از روی حرارت برداشته و پس از آنکه کمی سرد شد ، شربت را به میزان 2-3 قاشق غذاخوری، متناسب با دوز آرد به آن اضافه میکنند) یک فیلم کوتاه از مراحل کار نیز برای ایشان فرستاده خواهد شد. میزان مصرف روزانه کودکان به توجه به سن و وزن آنها بین 20-30 گرم سویق روزانه می باشد. شربت مصرف شده در مطالعه از شرکت دارویی خریداری میشود و آرد مصرفی از یک برند بازار خریداری میشود.

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Reza clinic
    Name of recruitment center - Persian: درمانگاه امام رضا
    Full name of responsible person - English: Mani Ramzi
    Full name of responsible person - Persian: مانی رمزی
    Street address - English: Imam Reza (AS) Specialized and Sub-Specialized Clinic, next to Namazi Hospital, Namazi S, Shirazquare
    Street address - Persian: شیراز، میدان نمازی، جنب بیمارستان نمازی، کلینیک ویژه تخصصی و فوق تخصصی امام رضا(ع)
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814734
    Phone: +98 71 3212 7000
    Fax:
    Email: motahari@sums.ac.ir
    Web page address: https://emamreza.sums.ac.ir/page-EmamRezaClinic1/fa/91
    Name of recruitment center - English: Imam Reza clinic
    Name of recruitment center - Persian: درمانگاه امام رضا
    Full name of responsible person - English: Mani Ramzi
    Full name of responsible person - Persian: مانی رمزی
    Street address - English: Imam Reza (AS) Specialized and Sub-Specialized Clinic, next to Namazi Hospital, Namazi S, Shiraz
    Street address - Persian: شیراز، میدان نمازی، جنب بیمارستان نمازی، کلینیک ویژه تخصصی و فوق تخصصی امام رضا(ع)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814734
    Phone: +98 71 3212 7000
    Fax:
    Email: motahari@sums.ac.ir
    Web page address: https://emamreza.sums.ac.ir/page-EmamRezaClinic1/fa/91

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: seyed vahid hosseini
    Full name of responsible person - Persian: سید وحید حسینی
    Street address - English: Central Building of Shiraz University of Medical Sciences and Health Services, Opposite Palestine St., Zand st, Shiraz
    Street address - Persian: شیراز، خیابان کریم خان زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شیراز
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3233 2366
    Fax:
    Email: President_d@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Vahid Hosseini
    Full name of responsible person - Persian: سید وحید حسینی
    Street address - English: Central Building of Shiraz University of Medical Sciences and Health Services, Opposite Palestine St., Zand st, Shiraz
    Street address - Persian: شیراز، خیابان کریم خان زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3233 2366
    Fax:
    Email: President_d@sums.ac.ir
    Web page address:
    #2
    contact.organization_id:
    Name of organization / entity - English: Research Center for Traditional Medicine and History of Medicine
    Name of organization / entity - Persian: مرکز تحقیقات طب سنتی و تاریخ طب
    Full name of responsible person - English: Majid Nimruzi
    Full name of responsible person - Persian: مجید نیمروزی
    Street address - English: Research Center for Traditional Medicine and Medical Historyو Eighth Floor, Building No. 2, School of Medicine, Imam Hossein (AS) Square, Shiraz
    Street address - Persian: شیراز، میدان امام حسین (ع)، دانشکده پزشکی، ساختمان شماره ۲، طبقه هشتم، مرکز تحقیقات طب سنتی و تاریخ پزشکی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3233 7589
    Fax:
    Email: tim@sums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research Center for Traditional Medicine and History of Medicine
    Name of organization / entity - Persian: مرکز تحقیقات طب سنتی و تاریخ طب
    Full name of responsible person - English: Majid Nimruzi
    Full name of responsible person - Persian: مجید نیمروزی
    Street address - English: Research Center for Traditional Medicine and Medical Historyو Eighth Floor, Building No. 2, School of Medicine, Imam Hossein (AS) Square, Shiraz
    Street address - Persian: شیراز، میدان امام حسین (ع)، دانشکده پزشکی، ساختمان شماره ۲، طبقه هشتم، مرکز تحقیقات طب سنتی و تاریخ پزشکی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3233 7589
    Fax:
    Email: tim@sums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of traditional wheat bran product on reducing the incidence of chemotherapeutic gastrointestinal complications in children with acute lymphoblastic leukemia undergoing chemotherapy
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 58 patients. For randomization in this study, the Restricted randomization method of block randomization has been used.
Settings and conduct
Samples were randomly selected from children aged 3 to 18 years with acute leukemia undergoing chemotherapy referred to Imam Reza's clinic in Shiraz and were divided into case and control groups. Intervention period: 4 weeks Before starting the study, patients will be divided into two groups A and B based on the attached checklist by block randomization method. The patient-level study will evaluate the outcome and statistically analyze the results. Only the drug maker can decode the contents of each sachet based on the original form stored in the randomization results. The person in charge of drug delivery, the patient, the doctor and the person in charge of evaluating the consequences will not know about the codings.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 3-18 years old with lymphoblastic leukemia undergoing chemotherapy Conditions of non-admission: Children in very serious condition and with a ban on treating physicians or candidates for surgery and extensive antibiotic treatment
Intervention groups
The traditional product "Wheat saviq with jollab" is given as a "complementary food" and "refined wheat flour with jollab equivalent syrup" as "placebo" is given to the case and control groups.
Main outcome variables
Prevention of gastrointestinal symptoms (diarrhea, constipation, bloating, dyspepsia, anorexia, nausea, vomiting, abdominal pain) in patients in the intervention group compared to the control group

General information

Reason for update
Correcting the sample size based on the correct and realistic criteria and announcing the end of sampling (The size of the initial sample was not based on realistic formulas and criteria, and due to the limitation in the number and low cooperation of children and parents in the cancer department, it was necessary to revise and correct it. Due to the special conditions and the limitation of the number of children with entry conditions To study, the previously mentioned number was somehow not possible.) Modified sample volume formula: In order to compare the average of the intended outcomes between the two sample size groups, taking into account the type 1 error and the power equal to 5 and 80% and the effect size equal to 0.8 (based on Cohen's criterion and due to the lack of a similar study in the studied population, i.e. children with leukemia) equal to 52 people (26 people in each group) was calculated using GPower software. Therefore, taking into account the dropout error equal to 10%, the final sample volume was determined to be 58 people (29 people in each group).
Acronym
IRCT registration information
IRCT registration number: IRCT20220410054474N1
Registration date: 2022-05-24, 1401/03/03
Registration timing: prospective

Last update: 2023-09-13, 1402/06/22
Update count: 1
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Saba Barkhori mehni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 5145
Email address
sababarkhori@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
2022-06-07, 1401/03/17
Actual recruitment end date
2023-06-10, 1402/03/20
Trial completion date
2023-06-10, 1402/03/20
Scientific title
Evaluating the effects of the traditional wheat product (saviq) on the pattern of changes caused bychemotherapy in the gastrointestinal tract of children with acute lymphoblastic leukemia referred to the Imam Rezaclinic in 1401 - a triple-blind clinical trial
Public title
Evaluating the effects of the traditional wheat product (saviq) on the pattern of changes caused bychemotherapy in the gastrointestinal tract of children with acute lymphoblastic leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3-18 years with severe lymphoblastic leukemia treated in the post-consolidation period.
Exclusion criteria:
Severely ill patients Patients who must be prescribed fasting by physician Patients with broad-spectrum antibiotics Patients with active infection Patients with celiac disease Those requiring gastrointestinal surgery Neutropenic patients
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 58
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization 1- Sequence generation (method used to generate random allocation sequence) 2- Randomization type, details of any constraints In this study, we will use the restricted randomization method of block randomization. The size of all blocks is equal and in this two-group experiment we will have 4 blocks (including 2 participants in the intervention group and 2 participants in the control group). For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows. AABB=1, ABAB=2, BBAA=3, BABA=4, ABBA=5, BAAB=6 With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number. In this three-blind trial, in addition to patients, researchers and analysts are unaware of which person is receiving the drug or placebo. Only the drug maker can decode the contents of each sachet based on the original form stored in the randomization results. Participant allocation concealment method (mechanism used to randomize participant allocation (such as consecutive numbered containers) and explain all the steps that can be taken to hide the sequence until the intervention is assigned to each group We use concealment allocation, which is the method used to execute random sequences on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed in random sequence (envelopes opaque, sealed, numbered Sequentially) In this method, each of the random sequences created is recorded on a card and the cards are placed in envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. (Who determines the random allocation sequence? Who enters the study participants? Who assigns the participants to the intervention groups?) A trained person outside the research team is responsible for randomly assigning patients, and at the time of registration of participants, they provide the participant with one of the sealed letter envelopes according to the order of entry of eligible participants. Put it to deliver to the researcher and he after opening the envelope, the group assigned to that participant, is determined for him and delivers the medicine package.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Before starting the study, patients will be divided into two groups A and B based on the attached checklist by block randomization method. Supplemental and placebo sachets will also be divided into containers labeled A and B by the drug manufacturer. Group A patients will receive drug A and group B patients will receive drug B. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded. Only the manufacturer of the drug can decode the contents of each sachet based on the original form stored in the randomization results. The person in charge of drug delivery, the patient, the doctor and the person in charge of evaluating the consequences will not know about the codings. The results of the two groups will be submitted to the statistical analyst under the headings of groups A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Persian medicine school, 9th floor, Medicine school, Zand street
City
shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.SUMS.MED.REC.1400.622

Health conditions studied

1

Description of health condition studied
Acute Lymphoblastic Leukemia
ICD-10 code
C91.01
ICD-10 code description
Acute lymphoblastic leukemia, in remission

Primary outcomes

1

Description
Occurrence of gastrointestinal symptoms
Timepoint
Beginning and end of the intervention; Days 0 and 28
Method of measurement
Pediatrics Quality of Life Questionnaire - gastrointestinal symptoms scales version 3.0

Secondary outcomes

1

Description
"Quality of life" of children - "Weight" of the child - "Blood test (CBC)" - "Gastrointestinal microbiome" - "Number of colonies created by the collection of bacteria in the feces"
Timepoint
All variables will be measured on day 0 and day 28 after the intervention.
Method of measurement
TAPQOL Quality of Life Questionnaire for Preschool Children (1-6 years old) and PedsQL Questionnaire for Quality of Life of Preschool Children- "Weight" of the child on day 0 and day 28 after the intervention"Blood test (CBC)" to check for blood factors including WBC Plt Hb RBC on day 0 and day 28 after intervention - "Stool test" of the child and performing Real-Time PCR to measure and determine the gastrointestinal microbiome on day 0 and day 28 after the intervention- Counting the number of colonies created by the collection of bacteria in the feces by microdilution culture on day 0 and 28 of the intervention

Intervention groups

1

Description
Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The product is given to the mother in the form of powder and the recipe is as follows: mix with boiling water and add Jollab syrup (which is given to the mother along with medicine sachets) and cook it briefly until it becomes halva. Jollab syrup (a combination of rose, saffron and sugar) is delivered to the mother ready with sachets containing soybean. The method of combining suviq and jollab will be explained to the mother both in writing and orally.Remove the resulting mixture from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, according to the dose of saviq.A short video of the work process was also sent to them. Product: Whole wheat saviq with jollab syrup - Jollab syrup preparation formula: three liters of rose water per kilogram of sugar + half a pound of saffron (about two grams) _ daily consumption of children depending on their age and weight between 20-30 grams Saviq. The jollab syrup is purchased from a pharmaceutical company and saviq is produced by the pharmacist of the study.
Category
Other

2

Description
"Refined wheat flour" is given to the control group as a placebo. It should be eaten once a day for four weeks. The time of consumption of the food composition is one meal a day and preferably in the middle of the morning meal. The placebo is given to the mother in the form of powder and the recipe is as follows: Placebo syrup (which is given to the mother along with placebo sachets) and cook it briefly until it becomes halva. In the placebo group, a syrup with the same color, taste and aroma of jalab is given, which is without rose and saffron and contains only a small amount of essential oil. The method of mixing flour and syrup will also be explained to the mother in writing orally. Remove from the heat and after it has cooled a little, add 2-3 tablespoons of syrup, depending on the dose of flour) (a short video of the steps will be sent to them. The daily consumption of children, depending on their age and weight, is between 20-30 grams per day. The syrup used in the study is purchased from a pharmaceutical company and the consumed flour is purchased from a specific brand in the market.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Mani Ramzi
Street address
Imam Reza (AS) Specialized and Sub-Specialized Clinic, next to Namazi Hospital, Namazi S, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
motahari@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/page-EmamRezaClinic1/fa/91

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Vahid Hosseini
Street address
Central Building of Shiraz University of Medical Sciences and Health Services, Opposite Palestine St., Zand st, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 2366
Email
President_d@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
65
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

2

Sponsor
Name of organization / entity
Research Center for Traditional Medicine and History of Medicine
Full name of responsible person
Majid Nimruzi
Street address
Research Center for Traditional Medicine and Medical Historyو Eighth Floor, Building No. 2, School of Medicine, Imam Hossein (AS) Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 7589
Email
tim@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Traditional Medicine and History of Medicine
Proportion provided by this source
35
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
Shiraz University of Medical Sciences
Full name of responsible person
Saba Barkhori mehni
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine School, 7th floor, Medicine school, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 3234 5145
Email
saba.barkhori@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Zohali nejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine School, 7th floor, Medicine School, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 3234 5145
Email
zohalinm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saba Barkhori mehni
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine School, 7th floor, Medicine School, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 3234 5145
Email
saba.barkhori@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data can be shared, such as information about demographic characteristics and its main outcome.
When the data will become available and for how long
The access period starts six months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Only for researchers who want to do meta-analysis and systematic review
From where data/document is obtainable
zohalinm@sums.ac.ir Mohammad Ebrahim Zahlinezhad Assistant Professor of Persian Medicine and History of Medicine 00989173026200
What processes are involved for a request to access data/document
Evaluation of the letter and details of the request by the supervisor and the main executor of the project And presentation of the issue in the weekly group meeting Estimated time: about two weeks
Comments
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