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Protocol summary
The study was an intervention and participants will receive cranberry extract and placebo as a single-sided blind and data analyzer will also be blind.
The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
The study was an intervention and participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
The study was an intervention and participants will receive cranberry extract and placebo as a singledouble-sided blind and data analyzer will also be blind. The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
مطالعه مداخله ای بوده و شرکت کنندگان به صورت یک سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
حجم نمونه 80 نفر خواهد بود که 50% حجم نمونه عصاره کرنبری و 50% دارونما به مدت 6 ماه دریافت کرده و سپس آنالیز خواهند شد.
مطالعه مداخله ای بوده و شرکت کنندگان به صورت دو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
حجم نمونه 80 نفر خواهد بود که 50% حجم نمونه عصاره کرنبری و 50% دارونما به مدت 6 ماه دریافت کرده و سپس آنالیز خواهند شد.
مطالعه مداخله ای بوده و شرکت کنندگان به صورت یکدو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود. حجم نمونه 80 نفر خواهد بود که 50% حجم نمونه عصاره کرنبری و 50% دارونما به مدت 6 ماه دریافت کرده و سپس آنالیز خواهند شد.
The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz.
Participants will receive cranberry extract and placebo as a single-sided blind and data analyzer will also be blind.
The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz.
Participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz. Participants will receive cranberry extract and placebo as a singledouble-sided blind and data analyzer will also be blind.
مطالعه در کلینیک تخصصی بیمارستان امام رضای تبریز انجام خواهد شد.
شرکت کنندگان به صورت یک سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
مطالعه در کلینیک تخصصی بیمارستان امام رضای تبریز انجام خواهد شد.
شرکت کنندگان به صورت دو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
مطالعه در کلینیک تخصصی بیمارستان امام رضای تبریز انجام خواهد شد. شرکت کنندگان به صورت یکدو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
Entry conditions:
Patients with non-alcoholic fatty liver grade 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
No entry conditions:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Patients with fatty liver grade 1
Entry conditions:
Patients with non-alcoholic fatty liver grade 1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
No entry conditions:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Entry conditions: Patients with non-alcoholic fatty liver grade 1, 2 and 3 Patients with newly diagnosed fatty liver Candidates for fatty liver treatment No entry conditions: Patient dissatisfaction Rule out the diagnosis of fatty liver Patients with fatty liver grade 1
شرایط ورود:
بیماران مبتلا به کبد چرب غیر الکلی گرید 2 و 3
بیماران مبتلا به کبد چرب تازه تشخیص داده شده
بیماران کاندید درمان کبد چرب
شرایط عدم ورود:
عدم رضایت بیمار
رد تشخیص کبد چرب
بیماران مبتلا به کبد چرب گرید 1
شرایط ورود:
بیماران مبتلا به کبد چرب غیر الکلی گرید 1و 2 و 3
بیماران مبتلا به کبد چرب تازه تشخیص داده شده
بیماران کاندید درمان کبد چرب
شرایط عدم ورود:
عدم رضایت بیمار
رد تشخیص کبد چرب
شرایط ورود: بیماران مبتلا به کبد چرب غیر الکلی گرید 1و 2 و 3 بیماران مبتلا به کبد چرب تازه تشخیص داده شده بیماران کاندید درمان کبد چرب شرایط عدم ورود: عدم رضایت بیمار رد تشخیص کبد چرب بیماران مبتلا به کبد چرب گرید 1
Intervention group: The first intervention group includes patients with grade 2 and 3 liver who will receive one cranberry extract daily for 6 months.
Control group: The second intervention group includes patients with grade 2 and 3 liver who will receive one plasebo daily for 6 months.
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver who will receive one cranberry extract daily for 6 months.
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plasebo daily for 6 months.
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver who will receive one cranberry extract daily for 6 months. Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plasebo daily for 6 months.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گرید 2 و 3 می باشند که عصاره کرنبری روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد.
گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گرید 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گرید1و 2 و 3 می باشند که عصاره کرنبری روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد.
گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گرید1و 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گریدگرید1و 2 و 3 می باشند که عصاره کرنبری روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد. گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گریدگرید1و 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد.
General information
Single blinded
Double blinded
singldoubl
1
1
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for increasing generalizability of result all patients with NAFLD (grade 1-3) were included.
moreover, some confounding factors that affect the result of the study were considered as exclusion criteria such as alcohol consumption and use of vitamin and antioxidant supplements.
for increasing generalizability of result all patients with NAFLD (grade 1-3) were included. moreover, some confounding factors that affect the result of the study were considered as exclusion criteria such as alcohol consumption and use of vitamin and antioxidant supplements.
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جهت افزایش تعمیم پذیری مطالعه تمام بیماران کبد چرب با هر نوع گریدی (1 تا 3) وارد مطالعه شدند.
همچنین برخی از عوامل اثر گذار بر نتیجه نیز مانند مصرف الکل و مکمل های ویتامینی و آنتی اکسیدانی به عنوان معیار خروج در نظر گرفته شدند.
جهت افزایش تعمیم پذیری مطالعه تمام بیماران کبد چرب با هر نوع گریدی (1 تا 3) وارد مطالعه شدند. همچنین برخی از عوامل اثر گذار بر نتیجه نیز مانند مصرف الکل و مکمل های ویتامینی و آنتی اکسیدانی به عنوان معیار خروج در نظر گرفته شدند.
Patients with non-alcoholic fatty liver grade 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
Patients with non-alcoholic fatty liver grade1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
Patients with non-alcoholic fatty liver gradegrade1, 2 and 3 Patients with newly diagnosed fatty liver Candidates for fatty liver treatment
بیماران مبتلا به کبد چرب غیر الکلی گرید 2 و 3
بیماران مبتلا به کبد چرب تازه تشخیص داده شده
بیماران کاندید درمان کبد چرب
بیماران مبتلا به کبد چرب غیر الکلی گرید1و 2 و 3
بیماران مبتلا به کبد چرب تازه تشخیص داده شده
بیماران کاندید درمان کبد چرب
بیماران مبتلا به کبد چرب غیر الکلی گریدگرید1و 2 و 3 بیماران مبتلا به کبد چرب تازه تشخیص داده شده بیماران کاندید درمان کبد چرب
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Drug intolerance
Existence of other liver diseases in which fatty liver appears in the picture
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Drug intolerance
Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture
alcohol consumption
antioxidant and vitamins supplements other that vitamin E
pregnant and lactating mothers
Patient dissatisfaction Rule out the diagnosis of fatty liver Drug intolerance Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture alcohol consumption antioxidant and vitamins supplements other that vitamin E pregnant and lactating mothers
عدم رضایت بیمار
رد تشخیص کبد چرب
عدم تحمل دارو
وجود بیماری های کبدی دیگر که در تابلوی انها کبد چرب ظاهر میشود
عدم رضایت بیمار
رد تشخیص کبد چرب
عدم تحمل دارو
وجود بیماری های دیابت، قلبی، کلیوی، ریوی و کبدی دیگر که در تابلوی انها کبد چرب ظاهر میشود
مصرف الکل
مصرف سایر داروهای انتی اکسیدان و ویتامینی بجز ویتامین E
مادران باردار و شیرده
عدم رضایت بیمار رد تشخیص کبد چرب عدم تحمل دارو وجود بیماری های دیابت، قلبی، کلیوی، ریوی و کبدی دیگر که در تابلوی انها کبد چرب ظاهر میشود مصرف الکل مصرف سایر داروهای انتی اکسیدان و ویتامینی بجز ویتامین E مادران باردار و شیرده
Participants will receive cranberry extract and placebo as a single-sided blind and data analyzer will also be blind.
Participants will receive cranberry extract and placebo as a double-sided blind.
Participants will receive cranberry extract and placebo as a singledouble-sided blind and data analyzer will also be blind.
شرکت کنندگان به صورت یک سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
شرکت کنندگان به صورت دو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد
شرکت کنندگان به صورت یکدو سویه کور عصاره کرن بری و دارونما را دریافت خواهند کرد و آنالیز کننده داده ها نیز کور خواهد بود.
Intervention groups
#1
Intervention group: The first intervention group includes patients with grade 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin،Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months.Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin،Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months.Possiblemonths. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گرید 2 و 3 می باشند.عصاره کرنبری به نام کرنبری شاری که نام برند بوده و نام تجاری آن Cranberry Shari می باشد. اجزا فرمولاسیون آن 144 میلی گرم عصاره میوه کرنبری (Vaccinium Macrocarporn) استاندارد شده بر اساس وجود 25% پروآنتوسیانیدین ، معادل 36 میلی گرم ماده موثره ( برابر با 13 گرم میوه خشک کرنبری ) می باشد.بیماران روزانه یک عدد ترجیحا همراه با غذا به مدت 6 ماه دریافت خواهند کرد. عوارض جانبی احتمالی دارو شامل اختلالات گوارشی ( تهوع و استفراغ ) و اسهال ( در صورت مصرف مقادیر بسیار زیاد) در جلسه اول به بیماران توضیح داده شده و سپس در جلسات بعدی مراجعه در مورد احتمال آن پرسش خواهد شد.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گرید1و 2 و 3 می باشند.عصاره کرنبری به نام کرنبری شاری که نام برند بوده و نام تجاری آن Cranberry Shari می باشد. اجزا فرمولاسیون آن 144 میلی گرم عصاره میوه کرنبری (Vaccinium Macrocarporn) استاندارد شده بر اساس وجود 25% پروآنتوسیانیدین ، معادل 36 میلی گرم ماده موثره ( برابر با 13 گرم میوه خشک کرنبری ) می باشد.بیماران روزانه یک عدد ترجیحا همراه با غذا به مدت 6 ماه دریافت خواهند کرد. عوارض جانبی احتمالی دارو شامل اختلالات گوارشی ( تهوع و استفراغ ) و اسهال ( در صورت مصرف مقادیر بسیار زیاد) در جلسه اول به بیماران توضیح داده شده و سپس در جلسات بعدی مراجعه در مورد احتمال آن پرسش خواهد شد.
گروه مداخله: گروه مداخله اول شامل بیماران مبتلا به کبد گریدگرید1و 2 و 3 می باشند.عصاره کرنبری به نام کرنبری شاری که نام برند بوده و نام تجاری آن Cranberry Shari می باشد. اجزا فرمولاسیون آن 144 میلی گرم عصاره میوه کرنبری (Vaccinium Macrocarporn) استاندارد شده بر اساس وجود 25% پروآنتوسیانیدین ، معادل 36 میلی گرم ماده موثره ( برابر با 13 گرم میوه خشک کرنبری ) می باشد.بیماران روزانه یک عدد ترجیحا همراه با غذا به مدت 6 ماه دریافت خواهند کرد. عوارض جانبی احتمالی دارو شامل اختلالات گوارشی ( تهوع و استفراغ ) و اسهال ( در صورت مصرف مقادیر بسیار زیاد) در جلسه اول به بیماران توضیح داده شده و سپس در جلسات بعدی مراجعه در مورد احتمال آن پرسش خواهد شد.
#2
Control group: The second intervention group includes patients with grade 2 and 3 liver who will receive one plasebo daily for 6 months.The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plaseboplacebo daily for 6 months.Themonths. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گرید 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد. مدت مصرف ، طرز مصرف آموزش بیماران و پیگیری بیماران کاملا طبق بیماران دریافت کننده داروی اصلی خواهد بود.
گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گرید1و 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد. مدت مصرف ، طرز مصرف آموزش بیماران و پیگیری بیماران کاملا طبق بیماران دریافت کننده داروی اصلی خواهد بود.
گروه کنترل:گروه مداخله دوم شامل بیماران مبتلا به کبد گریدگرید1و 2 و 3 می باشند که یک پلاسبو روزانه یک عدد به مدت 6 ماه دریافت خواهند کرد. مدت مصرف ، طرز مصرف آموزش بیماران و پیگیری بیماران کاملا طبق بیماران دریافت کننده داروی اصلی خواهد بود.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Kourosh Masnadi shirazi nezhad
Full name of responsible person - Persian: کوروش مسندی شیرازی نژاد
Street address - English: Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
Street address - Persian: خیابان گلگشت، روبروی سازمان مرکزی دانشگاه، مرکز آموزشی درمانی امام رضا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614756
Phone: +98 41 3334 7054
Fax:
Email: elham.shirinpour67@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences
Name of organization / entity - Persian: مرکز تحقیقات بیماری های گوارش و کبد دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Mohammad hossein Somi
Full name of responsible person - Persian: محمد حسین صومی
Street address - English: Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
Street address - Persian: خیابان گلگشت، روبروی سازمان مرکزی دانشگاه، مرکز آموزشی درمانی امام رضا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614756
Phone: +98 41 3334 7054
Fax:
Email: elham.shirinpour67@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences Name of organization / entity - Persian: مرکز تحقیقات بیماری های گوارش و کبد دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Kourosh Masnadi shirazi nezhadMohammad hossein Somi Full name of responsible person - Persian: کوروش مسندی شیرازی نژادمحمد حسین صومی Street address - English: Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center Street address - Persian: خیابان گلگشت، روبروی سازمان مرکزی دانشگاه، مرکز آموزشی درمانی امام رضا City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614756 Phone: +98 41 3334 7054 Fax: Email: elham.shirinpour67@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of cranberry extract on the response to treatment regimen of fatty liver patients on liver enzymes, ultrasound grade, lipid profile and serum glucose levels
Design
The study was an intervention and participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
Settings and conduct
The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz.
Participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
Participants/Inclusion and exclusion criteria
Entry conditions:
Patients with non-alcoholic fatty liver grade 1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
No entry conditions:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Intervention groups
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver who will receive one cranberry extract daily for 6 months.
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plasebo daily for 6 months.
Main outcome variables
Determination of lipid profile level before and after cranberry and placebo use
Determination of serum insulin and fasting glucose levels before and after cranberry and placebo
Determination of Ultrasound grade before and after cranberry and placebo
Determination of serum levels of liver enzymes before and after cranberry and placebo
General information
Reason for update
for increasing generalizability of result all patients with NAFLD (grade 1-3) were included.
moreover, some confounding factors that affect the result of the study were considered as exclusion criteria such as alcohol consumption and use of vitamin and antioxidant supplements.
Acronym
IRCT registration information
IRCT registration number:IRCT20200725048200N1
Registration date:2020-08-11, 1399/05/21
Registration timing:registered_while_recruiting
Last update:2021-04-07, 1400/01/18
Update count:2
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Elham Shirinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3389 3038
Email address
elham.shirinpour67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-27, 1399/05/06
Expected recruitment end date
2021-07-28, 1400/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Cranbery in management of non-alcoholic Fatty Liver Patients
Public title
Evaluation of the efficacy of Cranbery in treatment of Fatty Liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver grade1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
Exclusion criteria:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Drug intolerance
Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture
alcohol consumption
antioxidant and vitamins supplements other that vitamin E
pregnant and lactating mothers
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will receive cranberry extract and placebo as a double-sided blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.TBZMED.REC.1399.090
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Determination of lipid profile level before and after cranberry and placebo use
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests
2
Description
Determination of serum insulin and fasting glucose levels before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests
3
Description
Determination of Ultrasound grade before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Ultrasound device
4
Description
Determination of serum levels of liver enzymes before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
Category
Treatment - Drugs
2
Description
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Elham Shirinpour
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad hossein Somi
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastrointestinal and Liver Diseases Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Kourosh Masnadi shirazi nezhad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
kurmas23@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kourosh Masnadi shirazi nezhad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
kurmas23@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Shirinpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, patients' identities are not shared.
When the data will become available and for how long
Access period starts 12 months after the results are published.
To whom data/document is available
Data will only be available to researchers in this study.
Under which criteria data/document could be used
The data will be available to researchers only for meta-analysis study and for data analysis.
From where data/document is obtainable
Receipt of data will be done through the scientific respondent of the study.
What processes are involved for a request to access data/document
To receive the data, an email is sent to the scientific respondent and the reason for receiving the data is mentioned in detail and if the reasons are appropriate, the information will be sent.