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Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial

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History
# Registration date Revision Id
3 2020-08-16, 1399/05/26 147421
2 2019-08-14, 1398/05/23 100278
1 2016-04-08, 1395/01/20 21520
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  • Protocol summary

    (1) Objectives: The effect of a herbal compound on the amount of liver enzymes and blood fat in patients with nonalcoholic fatty liver (2) Design (study groups and phase, sample size, blinding, randomization) Study groups consist of 64 men and women with fatty liver disease in two experimental and control groups, each group consist of 32 patients. Trial is a single blind, Randomized controlled and Single-center study trial. This trial is a phase 1 clinical trial. (3) Setting and conduct Both of experimental and control groups take 2 capsules of drug three times daily for two months. (4) Participants including major eligibility criteria a- The desire to participate in the study, b- High level of liver enzyme ALT greater than 1.5 times normal, c- The degree of steatosis on sonography higher than 1, d- No history of alcohol abuse, e- Having no acute or chronic disease. (5) Intervention Improving chemical drug treatment of fatty liver disease. (6) Main outcome measures (primary and secondary outcome variables) Primary outcome variables: reducing hepatic enzymes, reducing the level of blood triglyceride and total cholesterol, reduce in liver steatosis by sonography.
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    (1) اهداف: تعیین اثرات یک ترکیب گیاهی بر میزان آنزیم های کبدی و چربی خون بیماران مبتلا به کبد چرب غیر الکلی (2) طراحی (شامل نکاتی در مورد جمعيت مورد مطالعه، گروه ها ، حجم نمونه، کورسازی، تصادفی سازی، تک یا چند مرکزی بودن و فازمطالعه)، جمعیت مورد مطالعه شامل 64 مرد وزن مبتلا به کبد چرب در دو گروه شاهد و کنترل میباشد که هر گروه شامل 32 نفر است. مطالعه بصورت یک سو کورو تصادفی کنترل شده میباشد. انجام مطالعه بصورت تک مرکزی است. مطالعه در فاز یک کارآزمایی بالینی میباشد. (3) نحوه انجام بمدت دو ماه گروه شاهد و کنترل در کنار داروهای شیمیایی خود سه نوبت در روز، هر نوبت دو کپسول استفاده مینمایند. (4) شرکت کنندگان شامل شرایط ورود و عدم ورود اصلی (ذکر کلیه معیارهای ورود و عدم ورود لازم نیست و تنها ذکر معیارهای کلیدی کافی است)، الف- تمایل به شرکت در مطالعه، (2) بالا بودن سطح سرمی آنزیم کبدی ALT بیشتر از 5/1 برابر طبیعی، (3) بالاتر از 1 بودن درجه ی استئاتوز در سونوگرافی بیمار، (4) عدم سابقه مصرف الکل، (5) عدم ابتلا به بیماری های خاص یا مزمن (5) مداخلات : کمک به درمان شیمیایی بیماری کبد چرب (6) متغیر های پیامد اصلی (شامل پیامد های اوليه و ثانویه( پیامدهای اولیه: کاهش سطح آنزیمهای کبدی، کاهش سطح تری گلیسیرید و کلسترول تام خون، کاهش درجه چربی کبد در سونوگرافی
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    on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease
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    jعیین اثرات یک ترکیب گیاهی بر شدت استئاتوز میزان آنزیم های کبدی و چربی خون بیماران مبتلا به کبد چرب غیر الکلی
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    Sixty-four patients with NAFLD were randomly divided into treatment and control groups (2:1 ratio).
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    60 بیمار دارای کبد چرب غیر الکللی به طور تصادفی به دو گروه درمان و کنترل (به نسبت 2 به 1، 20 بیمار گروه کنترل و 40 بیمار گروه درمان) تقسیم شدند.
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    The subjects for the study were derived from the Clinic of Internal Medicine, Emam-Reza Hospital, Mashhad University of Medical Sciences. The liver ultrasound and biochemical markers including the serum lipids, liver enzymes, and glucose were evaluated before starting the study and at the end of the treatment.
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    بیماران مورد مطالعه از کلینیک ویژه بیمارستان امام رضا در دانشگاه علوم پزشکی مشهد انتخاب شدند. پیش از شروع مطالعه و در پایان تحقیق سونوگرافی کبد و آزمایشات بیوشیمیایی نظیر چربی خون، آنزیم های کبدی خون و سطح گلوکز اندازه گیری گردید.
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    Inclusion criteria: patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
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    شرایط ورود: بیماران مبتلا به کبد چرب غیر الکلی با درجه ی استئاتوز 2 و بالاتر در سونوگرافی یا درجه ی استئاتوز 1 بعلاوه ی افزایش سطح آلانین ترانس آمیناز سرم
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    Both control and group were advised to take healthy diet and exercise. The treatment group also received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months).
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    به هر دو گروه کنترل و درمان توصیه شد تا رژیم غذایی سالم را رعایت کنند و ورزش نمایند. علاوه بر این، گروه درمان به مدت 2 ماه هر روز در سه نوبت 2 عدد کپسول 400 میلی گرمی حاوی مخلوط شوید، بهار نارنج، کنگر فرنگی، خرفه و خار مریم دریافت نمود.
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    The primary outcome measures included change in grade of NAFLD in sonography and change in serum ALT level.
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    پیامد اصلی مطالعه درجه کبد چرب تعیین شده با سونوگرافی و میزان ALT سرم می باشد.

  • General information

    N/A
    Randomized
    Single blinded
    Not blinded
    Used
    Not used
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    No
    No
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    2016-04-20, 1395/02/01
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    2019-02-20, 1397/12/01
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    2019-03-19, 1397/12/28
    Evaluation of the effect of a herbal mixture at treatment of non alcoholic fatty liver disease
    Evaluation of the effect of a herbal mixture on non alcoholic fatty liver disease
    بررسی اثر یک ترکیب گیاهی در کمک به درمان بیماری کبد چرب غیر الکلی
    بررسی اثر یک ترکیب گیاهی بر بیماری کبد چرب غیر الکلی
    Evaluation of the effects of a Polyherbal compound on the level of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
    Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
    بررسی اثرات یک ترکیب گیاهی بر میزان چربی خون و آنزیم های کبدی بیماران مبتلا به کبد چرب: یک کارآزمايي باليني تصادفی شده
    بررسی اثرات یک ترکیب گیاهی بر شدت استئاتوز و میزان چربی خون و آنزیم های کبدی بیماران مبتلا به کبد چرب غیر الکلی: یک کارآزمايي باليني تصادفی شده
    patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
    بیماران مبتلا به کبد چرب غیر الکلی با درجه ی استئاتوز 2 و بالاتر در سونوگرافی یا درجه ی استئاتوز 1 بعلاوه ی افزایش سطح آلانین ترانس آمیناز سرم
    Having special or chronic disease like auto immune diseases, hypothyroidism, lupus, renal dysfunction, cancers, heart diseases, and severe infections
    Cirrhosis or Hepatitis B and C
    Pregnancy and lactation
    Unwillingness to continue treatment with herbal compound
    ابتلا به بیماری های خاص یا مزمن نظیر بیماری ایمنی، هیپوتیروئیدی، لوپوس، نارسایی کلیه، بیماری قلب عروقی، سرطان و عفونت شدید
    سیروز و هپاتیت B و C
    حاملگی یا شیردهی
    دم تمایل به ادامه درمان با ترکیب گیاهی
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    Block randomization
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    تصادفی سازی بلوک
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  • Primary outcomes

    #1
    Total cholestrol
    Alanine transaminase (ALT)
    کلسترول تام
    آلانین ترانس آمیناز سرم
    #2
    VLDL
    Steatosis of liver
    VLDL
    گرید کبد چرب
    Blood examination
    Sonography
    آزمایش خون
    سونوگرافی
    #3
    LDL
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    LDL
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    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
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    آزمایش خون
    empty
    #4
    HDL
    empty
    HDL
    empty
    Before intervention, two month after intervention
    empty
    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
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    آزمایش خون
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    #5
    Triglyceride
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    تری گلیسرید
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    Before intervention, two month after intervention
    empty
    قبل از مداخله، دو ماه پس از شروع مداخله
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    Blood examination
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    آزمایش خون
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    #6
    Fasting blood sugar
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    قند خون ناشتا
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    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
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    آزمایش خون
    empty
    #7
    ALT
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    آنزیم آلکالن فسفاتاز
    empty
    Before intervention, two month after intervention
    empty
    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
    empty
    آزمایش خون
    empty
    #8
    AST
    empty
    آنزیم اسید فسفاتاز
    empty
    Before intervention, two month after intervention
    empty
    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
    empty
    آزمایش خون
    empty
    #9
    Bilirubin
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    بیلی روبین خونی
    empty
    Before intervention, two month after intervention
    empty
    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
    empty
    آزمایش خون
    empty
    #10
    Blood urea
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    اوره خون
    empty
    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
    empty
    آزمایش خون
    empty
    #11
    Blood creatinine
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    کراتینین خون
    empty
    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
    empty
    Blood examination
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    آزمایش خون
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    #12
    Steatosis of liver
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    گرید کبد چرب
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    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
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    Sonography
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    سونوگرافی
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    #13
    Body Mass Index
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    ضریب وزنی بدن
    empty
    Before intervention, two month after intervention
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    قبل از مداخله، دو ماه پس از شروع مداخله
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    Calculation
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    محاسبه قد و وزن
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  • Secondary outcomes

    #1
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    aspartate transaminase (AST)
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    آسپارتات ترانس آمیناز
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    Before starting study and 2 months after starting study
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    قبل از شروع مطالعه و 2 ماه بعد از شروع مطالعه
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    Blood analysis (kit)
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    کیت اندازه گیری در خون
    #2
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    fasting blood glucose
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    قند خون ناشتا
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    Before starting study and 2 months after starting study
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    قبل از شروع مطالعه و 2 ماه بعد از شروع مطالعه
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    Blood analysis (kit)
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    کیت اندازه گیری در خون
    #3
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    serum lipids
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    چربی های خون
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    Before starting study and 2 months after starting study
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    قبل از شروع مطالعه و 2 ماه بعد از شروع مطالعه
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    Blood analysis (kit) for total cholesterol and triglyceride
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    کیت اندازه گیری کلسترول و تری گلیسرید در خون

  • Intervention groups

    #1
    Intervention group: Take 2 capsules equal to 2 g from herbal mixture after every meal ( three times daily) for 8 weeks.
    The treatment group received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months)> Both treatment and control group were advised to take healthy diet and exercise.
    گروه مداخله: دو کپسول معادل دو گرم از ترکیب گیاهی سه نوبت در روز (پس از صبحانه، نهار و شام) به مدت 8 هفته میل شود.
    گروه درمان کپسول های 400 میلی گرمی حاوی شوید، بهار نارنج، کنگر فرنگی، خرفه و خار مریم (2 کپسول، سه نوبت در روز به مدت 2 ماه) دریافت می کنند. به هر دو گروه درمان و کنترل توصیه می شود تا رژیم غذایی سالم را رعایت کنند و ورزش نمایند.
    #2
    Treatment - Drugs
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    Control group: Take 2 capsules equal to 2 g from placebo after every meal ( three times daily) for 8 weeks.
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    گروه کنترل: دو کپسول معادل دو گرم از ترکیب دارونما سه نوبت در روز (پس از صبحانه، نهار و شام) به مدت 8 هفته میل شود.
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  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Reza Hospital Special Clinic
    Name of recruitment center - Persian: کلینیک ویژه بیمارستان امام رضا (ع)
    Full name of responsible person - English: Seyyed Abbas Zojaji
    Full name of responsible person - Persian: دکتر سید عباس زجاجی
    Street address - English: Emam Reza Hospital, Emam Reza Square
    Street address - Persian: میدان بیمارستان امام رضا (ع)
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital Special Clinic
    Name of recruitment center - Persian: کلینیک ویژه بیمارستان امام رضا (ع)
    Full name of responsible person - English: Seyyed Abbas Zojaji
    Full name of responsible person - Persian: دکتر سید عباس زجاجی
    Street address - English: Emam Reza Hospital, Emam Reza Square
    Street address - Persian: میدان بیمارستان امام رضا (ع)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3854 3031
    Fax:
    Email: sabbaszojaji@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for Research, Mashhad University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه عوم پزشکی مشهد
    Full name of responsible person - English: Dr Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Vice chancellor for Research of Mashhad University of Medical Science, Ghoreyshi Building, Daneshgah Avenue
    Street address - Persian: ساختمان قریشی، معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for Research, Mashhad University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه عوم پزشکی مشهد
    Full name of responsible person - English: Dr Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Vice chancellor for Research of Mashhad University of Medical Science, Ghoreyshi Building, Daneshgah Avenue
    Street address - Persian: ساختمان قریشی، معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9138813944
    Phone: +98 51 3841 2081
    Fax:
    Email: ramresearch@mums.ac.ir
    Web page address:
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    Public
    empty
    Domestic
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    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Exir Teb Zakaria company
    Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
    Full name of responsible person - English: Dr Seyyed Abbas Zojaji
    Full name of responsible person - Persian: دکتر سید عباس زجاجی
    Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
    Street address - Persian: میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Exir Teb Zakaria company
    Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
    Full name of responsible person - English: Dr Seyyed Abbas Zojaji
    Full name of responsible person - Persian: دکتر سید عباس زجاجی
    Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
    Street address - Persian: میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9196773117
    Phone: +98 51 3711 2718
    Fax:
    Email: ExirTebeZakaria@gmail.com
    Web page address:
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    empty
    Private
    empty
    Domestic
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    Industry

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Exir Teb Zakaria Company
    Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
    Full name of responsible person - English: Seyyed Abbas Zojaji
    Full name of responsible person - Persian: سید عباس زجاجی
    Position - English: Ph.D of Pharmacology/CEO
    Position - Persian: Ph.D فارماکولوژی/مدیر عامل
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 3, Goldis 3 avenue, Ladan boulevard
    Street address - Persian: بلوار لادن، گلدیس 3، پلاک 3
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 51 3502 4824
    Mobile: +98 936 185 8500
    Fax:
    Email: exirtebzakaria@gmail.com
    Web page address: www.etzakaria.com
    contact.organization_id:
    Name of organization / entity - English: Exir Teb Zakaria Company
    Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
    Full name of responsible person - English: Seyyed Abbas Zojaji
    Full name of responsible person - Persian: سید عباس زجاجی
    Position - English: Managing Director
    Position - Persian: Ph.D فارماکولوژی/مدیر عامل
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    City - English: Mashhad
    City - Persian: Mashhad
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3502 4824
    Mobile: +98 936 185 8500
    Fax:
    Email: exirtebzakaria@gmail.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants
    Name of organization / entity - Persian: دانشکده پزشکی مشهد، مرکز تحقیقات فارماکولوژیک گیاهان دارویی
    Full name of responsible person - English: Ahmad Ghorbani
    Full name of responsible person - Persian: احمد قربانی
    Position - English: Assistant Professor/ Physiology Ph.D
    Position - Persian: Ph.D فیزیولوژی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pharmacological Research Center of Medicinal Plants, Mashhad Medical School, Mashhad University Pardis
    Street address - Persian: پردیس دانشگاه مشهد، دانسکده پزشکی مشهد، مرکز تحقیقات فارماکولوژیک گیاهان دارویی
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 51 3711 2717
    Mobile: +98 915 314 8741
    Fax:
    Email: ghorbania@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants
    Name of organization / entity - Persian: دانشکده پزشکی مشهد، مرکز تحقیقات فارماکولوژیک گیاهان دارویی
    Full name of responsible person - English: Ahmad Ghorbani
    Full name of responsible person - Persian: احمد قربانی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    City - English: Mashhad
    City - Persian: Mashhad
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3800 2278
    Mobile: +98 915 314 8741
    Fax:
    Email: ghorbania@mums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmad Ghorbani
    Full name of responsible person - Persian: احمد قربانی
    Position - English: Associate Prof.
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
    City - English: Mashhad
    City - Persian: Mashhad
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3800 2278
    Mobile: +98 915 314 8741
    Fax:
    Email: ghorbania@mums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    na
    undecided
    undecided
    na
    na
    empty
    There is no further information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease
Design
Sixty-four patients with NAFLD were randomly divided into treatment and control groups (2:1 ratio).
Settings and conduct
The subjects for the study were derived from the Clinic of Internal Medicine, Emam-Reza Hospital, Mashhad University of Medical Sciences. The liver ultrasound and biochemical markers including the serum lipids, liver enzymes, and glucose were evaluated before starting the study and at the end of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
Intervention groups
Both control and group were advised to take healthy diet and exercise. The treatment group also received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months).
Main outcome variables
The primary outcome measures included change in grade of NAFLD in sonography and change in serum ALT level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2015123025772N1
Registration date: 2016-04-08, 1395/01/20
Registration timing: prospective

Last update: 2019-08-15, 1398/05/24
Update count: 2
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical science, Exir teb zakaria company
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-15, 1395/03/26
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
Public title
Evaluation of the effect of a herbal mixture on non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
Exclusion criteria:
Having special or chronic disease like auto immune diseases, hypothyroidism, lupus, renal dysfunction, cancers, heart diseases, and severe infections Cirrhosis or Hepatitis B and C Pregnancy and lactation Unwillingness to continue treatment with herbal compound
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Science
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
IR.MUMS.fm.REC.1394.114

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver desease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Alanine transaminase (ALT)
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination

2

Description
Steatosis of liver
Timepoint
Before intervention, two month after intervention
Method of measurement
Sonography

Secondary outcomes

1

Description
aspartate transaminase (AST)
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit)

2

Description
fasting blood glucose
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit)

3

Description
serum lipids
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit) for total cholesterol and triglyceride

Intervention groups

1

Description
The treatment group received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months)> Both treatment and control group were advised to take healthy diet and exercise.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital Special Clinic
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Emam Reza Hospital, Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sabbaszojaji@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for Research of Mashhad University of Medical Science, Ghoreyshi Building, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Mashhad University of Medical Science
Proportion provided by this source
70
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
Exir Teb Zakaria company
Full name of responsible person
Dr Seyyed Abbas Zojaji
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2718
Email
ExirTebeZakaria@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Teb Zakaria company
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Exir Teb Zakaria Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
Managing Director
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3502 4824
Fax
Email
exirtebzakaria@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants
Full name of responsible person
Ahmad Ghorbani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Fax
Email
ghorbania@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Associate Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Email
ghorbania@mums.ac.ir

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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