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The effect of capsule contain cumin essential oil on weight and metabolic profiles of obese and overweight patients and its comparison with orlistat

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History
# Registration date Revision Id
3 2019-09-25, 1398/07/03 163528
2 2014-05-20, 1393/02/30 12496
1
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  • Protocol summary

    This study is a randomized double blind , controlled with drug and placebo , single- center , parallel clinical trial on 105 overweight and obese patients aged 18 to 50 who have any metabolic disease and don’t use nutritional supplement .Their baseline weight , BMI and metabolic profiles will be checked and devided to one of the groups received a capsules cumin, venustat capsules or placebo capsules three times daily for 8 weeks randomly. Patients don’t change in Physical Activity and get food that cheked with standardized questionnaires . Finally the weight changes , metabolic profile , liver enzymes ,thyroid hormones , inflammatory markers and antioxidant parameters is measured
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    این مطالعه به صورت کارآزمایی بالینی دو سوکور، کنترل شده با دارو و پلاسبو، تصادفی به صورت تک مرکزی و موازی بر روی 105 بیمار مبتلا به اضافه وزن و چاقی 18 تا 50 ساله که بیماریهای زمینه ای نداشته و مکمل تغذیه ای مصرف نمیکنند اجرا میشود. افراد در ابتدای مطالعه از نظر وزن،BMI و پروفایل متابولیک بررسی میشوند و تصادفا در یکی از گروههای دریافت کننده کپسول زیره،کپسول ونوستات یا کپسول پلاسبو 3 بار در روز به مدت 8 هفته قرار خواهند گرفت. افراد در این مدت تغییری در میزان فعالیت و دریافت غذایشان ایجاد نمیکنند و این موضوع با پرسشنامه های استاندارد سنجیده میشود.در پایان مطالعه تغییرات وزن، پروفایل متایولیک، آنزیمهای کبدی،هورمونهای تیروئیدی، شاخصهای التهابی و آنتی اکسیدانی افراد اندازه گیری میشود.
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    The aim of this study is to determine the effects of cumin capsules and orlistat on weight changes and metabolic profiles in patients with overweight and obese.
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    هدف این مطالعه تعیین اثرات کپسول زیره و ارلیستات بر تغییرات وزن و پروفایل متابولیک در بیماران مبتلا به اضافه وزن و چاقی است.
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    Randomized double-blind placebo-controlled trial.
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    کارآزمایی بالینی تصادفی شده دو سوکور، کنترل شده با دارونما.
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    Among patients with overweight referred to the Naghavi Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 87 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. Intervention period: 8 weeks.
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    از بین بیماران مبتلا به اضافه وزن ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 87 بیمار انتخاب خواهند شد. این مطالعه به صورت دوسویه کور است و هم شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند. داروها و پلاسبو مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
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    Inclusion criteria: Overweight (Body mass index range: 25.2–48.8 kg/m 2) and subjects aged 18–60. Exclusion criteria: Those with malignancy, metabolic, thyroid or cardiovascular disorders, pregnancy and lactation, and those using hormonal, antidiabetic, or anti-obesity medications.
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    معیارهای ورود به مطالعه: اضافه وزن (دامنه توده نمایه بدن 25.2-48.8 کیلوگرم در متر مربع) و افراد 18 تا 60 ساله. معیارهای خروج: افراد مبتلا به اختلالات بدخیمی، متابولیکی، تیروئید یا قلبی عروقی، بارداری و شیردهی، و افرادی که از داروهای هورمونی، ضد دیابتی یا ضد چاقی استفاده می کنند.
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    Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks. Control group: Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
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    گروه مداخله 1: کپسول روغن اسانس زیره (شرکت دارویی باریج اسانس، کاشان، ایران)، خوراکی، 3 بار در روز، برای 8 هفته. گروه مداخله 2: کپسول ارلیستات (شرکت هافمن-لا روش، مونیخ، آلمان)، خوراکی، 3 بار در روز، برای 8 هفته. گروه کنترل: کپسول دارونما (شرکت دارویی باریج اسانس، کاشان، ایران)، خوراکی، 3 بار در روز، برای 8 هفته.
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    Weight change
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    تغییر وزن

  • General information

    50
    60
    1
    1
    1
    2-3
    3
    105
    87
    2014-06-22, 1393/04/01
    2014-04-27, 1393/02/07
    2015-01-21, 1393/11/01
    2015-05-15, 1394/02/25
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    Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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    بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    The effect of capsule contain cumin essential oil on weight and metabolic profile of obese and over weight patients and its comparison with venustat
    The effect of capsule contain cumin essential oil on weight and metabolic profiles of obese and overweight patients and its comparison with orlistat
    بررسی اثر بخشی کپسول خوراکی حاوی اسانس زیره بر تغییرات وزن و پروفایل متابولیک افراد مبتلا به چاقی و اضافه وزن و مقایسه آن با ونوستات
    اثر کپسول حاوی اسانس زیره بر روی وزن و پروفایل متابولیک بیماران چاق و اضافه وزن و مقایسه آن با ارلیستات
    Overweight (Body mass index range: 25.2–48.8 kg/m 2)
    Aged 18–60
    اضافه وزن (توده نمایه بدن محدوده 25.2 تا 48.8 کیلوگرم به ازای هر متر مربع)
    سن 18 تا 60 سال
    Those with malignancy
    Metabolic disorders
    Thyroid disorders
    Cardiovascular disorders
    Pregnancy and lactation
    Those using hormonal, antidiabetic, or anti-obesity medications
    مبتلایان به بد خیمی ها
    اختلالات متابولیکی
    اختلالات تیروئیدی
    اختلالات قلبی عروقی
    بارداری و شیردهی
    افرادی که از داروهای هورمونی ، ضد دیابتی یا ضد چاقی استفاده می کنند
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    Patients will be randomly assigned into three groups. A list of random numbers from 1 to 87 using a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) will be generated, and then patients will be randomly assigned using numbers into three groups. At study baseline, after stratification for gender, pre-intervention body mass index and age, subjects were randomly assigned to three groups. Randomization will be done by the use of computer-generated random numbers.
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    بیماران به طور تصادفی به سه گروه تخصیص داده خواهند شد. یک لیست از اعداد تصادفی از 1 تا 87 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به سه گروه مداخله تخصیص داده خواهند شد. در ابتدای مطالعه، بعد از طبقه بندی براساس جنس، توده نمایه بدن قبل از مداخله و سن، افراد به سه گروه برای دریافت داروها و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Placebo capsules contained microcrystalline cellulose and were packed in identical capsules with drugs, and coded by Barij Essence Pharmaceutical company to guarantee blinding. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده داروها را تخصیص خواهد داد. کپسول های پلاسبو حاوی سلولز میکروکریستالین بود و در کپسول های مشابه با داروها بسته بندی شد و در شرکت دارویی باریج اسانس برای تضمین کورسازی کدگذاری شد. بیماران و محققین از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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  • Health conditions studied

    #1
    obesity and over weight
    Obesity and overweight

  • Primary outcomes

    #1
    weight
    Weight change
    وزن
    تغییر وزن
    baseline and end of study
    Baseline and end of study
    scale
    Scale
    #2
    metabolic profile
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    پروفایل متابولیک
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    baseline and end of study
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    ابتدا و انتهای مطالعه
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    blood test
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    آزمایش خون
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    #3
    liver enzymes
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    آنزیم های کبدی
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    baseline and end of study
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    ابتدا و انتهای مطالعه
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    blood test
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    آزمایش خون
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    #4
    total anti oxidant
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    آنتی اکسیدان تام پلاسما
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    baseline and end of study
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    ابتدا و انتهای مطالعه
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    blood test
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    آزمایش خون
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    #5
    Thyroid hormones
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    هورمونهای تیروئیدی
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    baseline and end of study
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    ابتدا و انتهای مطالعه
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    blood test
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    آزمایش خون
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  • Secondary outcomes

    #1
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    Total cholesterol
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    کلسترول تام
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #2
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    Insulin
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    انسولین
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    ELISA kit
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    کیت الایزا
    #3
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    Triglycerides
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    تری گلیسیرید
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #4
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    HDL-cholesterol
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    HDL-کلسترول
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #5
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    LDL-cholesterol
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    LDL-کلسترول
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #6
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    Glutathione
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    گلوتاتیون
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Spectrophotometry
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    اسپکتروفتومتری
    #7
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    Fasting plasma glucose
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    گلوکز پلاسمایی ناشتا
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Enzymatic kit
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    کیت آنزیمی
    #8
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    Insulin resistance
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    مقاومت به انسولین
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Calculation using HOMA formula
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    محاسبه با استفاده از فرمول HOMA
    #9
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    Thyroid hormones
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    هورمون های تیروئیدی
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    ELISA kit
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    کیت الایزا
    #10
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    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی تام
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    Baseline and end of study
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    ابتدا و انتهای مطالعه
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    Spectrophotometry
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    اسپکتروفتومتری

  • Intervention groups

    #1
    Intervention:cumin essential oil capsule 3 times a day for 8 weeks
    Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
    گروه مداخله:کپسول خوراکی حاوی اسانس زیره روزانه 3 عدد تا 8 هفته
    گروه مداخله 1: کپسول روغن اسانس زیره (شرکت دارویی باریج اسانس، کاشان، ایران)، خوراکی، 3 بار در روز، برای 8 هفته.
    #2
    drug control:venustat capsule 3 times a day for 8 weeks
    Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks.
    گروه کنترل دارویی:کپسول ونوستات روزانه 3 عدد تا 8 هفته
    گروه مداخله 2: کپسول ارلیستات (شرکت هافمن-لا روش، مونیخ، آلمان)، خوراکی، 3 بار در روز، برای 8 هفته.
    #3
    placebo control:placebo capsule 3 times a day for 8 weeks
    Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
    گروه کنترل پلاسبو:کپسول پلاسبو روزانه 3 عدد تا 8 هفته
    گروه کنترل: کپسول دارونما (شرکت دارویی باریج اسانس، کاشان، ایران)، خوراکی، 3 بار در روز، برای 8 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Diet therapy clinics affiliated to Kashan University of Medical Sciences
    Name of recruitment center - Persian: کلینیک رژیم درمانی وابسته به دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5562 0608
    Fax:
    Email: Asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: Miss L.Hejazi
    Full name of responsible person - Persian: سرکار خانم لاله حجازی
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان-مشهد اردهال
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: Miss L.Hejazi
    Full name of responsible person - Persian: سرکار خانم لاله حجازی
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان-مشهد اردهال
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5562 0608
    Fax:
    Email: mohsenta44@yahoo.com
    Web page address:
    Yes
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    Public
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    Domestic
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    Academic
    Barij Research Center of Medicinal Herbs
    Kashan University of Medical Sciences
    مرکز تحقیقات گیاهان دارویی باریج
    دانشگاه علوم پزشکی کاشان

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr.M.Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1555 0021
    Mobile: 00
    Fax:
    Email: taghizadeh_m@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Mohsen Taghizadeh
    Full name of responsible person - Persian: دکتر محسن تقی زاده
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 36 1555 0021
    Mobile: +98 913 363 3213
    Fax:
    Email: taghizadeh_m@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PHD
    Position - Persian: دکتری تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan University Of Medical Sciences, Kashan
    Street address - Persian: کاشان. دانشگاه علوم پزشکی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 36 1555 0021
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Position - English: PhD
    Position - Persian: دکتری تخصصی
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 36 1555 0021
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Barij Research Center of Medicinal Herbs
    Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
    Full name of responsible person - English: M.Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Expert
    Position - Persian: کارشناس بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 86 4446 5112
    Mobile: 00
    Fax:
    Email: mahnaz.mahlouji@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahnaz Mahlouji
    Full name of responsible person - Persian: خانم مهناز محلوجی
    Position - English: Clinical Expert
    Position - Persian: کارشناس بالینی
    Latest degree: bachelor
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kashan Mashhad Ardehal Road, KM44
    Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 86 4446 5112
    Mobile: +98 913 363 3213
    Fax:
    Email: mahnaz.mahlouji@gmail.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effects of cumin capsules and orlistat on weight changes and metabolic profiles in patients with overweight and obese.
Design
Randomized double-blind placebo-controlled trial.
Settings and conduct
Among patients with overweight referred to the Naghavi Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 87 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. Intervention period: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight (Body mass index range: 25.2–48.8 kg/m 2) and subjects aged 18–60. Exclusion criteria: Those with malignancy, metabolic, thyroid or cardiovascular disorders, pregnancy and lactation, and those using hormonal, antidiabetic, or anti-obesity medications.
Intervention groups
Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks. Control group: Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
Main outcome variables
Weight change

General information

Reason for update
Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number: IRCT2014043012438N8
Registration date: 2014-05-20, 1393/02/30
Registration timing: registered_while_recruiting

Last update: 2020-12-18, 1399/09/28
Update count: 1
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2014-04-27, 1393/02/07
Expected recruitment end date
2015-05-15, 1394/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of capsule contain cumin essential oil on weight and metabolic profiles of obese and overweight patients and its comparison with orlistat
Public title
The effect of cumin pearl on treatment of obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight (Body mass index range: 25.2–48.8 kg/m 2) Aged 18–60
Exclusion criteria:
Those with malignancy Metabolic disorders Thyroid disorders Cardiovascular disorders Pregnancy and lactation Those using hormonal, antidiabetic, or anti-obesity medications
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 87
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into three groups. A list of random numbers from 1 to 87 using a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) will be generated, and then patients will be randomly assigned using numbers into three groups. At study baseline, after stratification for gender, pre-intervention body mass index and age, subjects were randomly assigned to three groups. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Placebo capsules contained microcrystalline cellulose and were packed in identical capsules with drugs, and coded by Barij Essence Pharmaceutical company to guarantee blinding. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
633/1/5/29/ب

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
Weight change
Timepoint
Baseline and end of study
Method of measurement
Scale

Secondary outcomes

1

Description
Total cholesterol
Timepoint
Baseline and end of study
Method of measurement
Enzymatic kit

2

Description
Insulin
Timepoint
Baseline and end of study
Method of measurement
ELISA kit

3

Description
Triglycerides
Timepoint
Baseline and end of study
Method of measurement
Enzymatic kit

4

Description
HDL-cholesterol
Timepoint
Baseline and end of study
Method of measurement
Enzymatic kit

5

Description
LDL-cholesterol
Timepoint
Baseline and end of study
Method of measurement
Enzymatic kit

6

Description
Glutathione
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry

7

Description
Fasting plasma glucose
Timepoint
Baseline and end of study
Method of measurement
Enzymatic kit

8

Description
Insulin resistance
Timepoint
Baseline and end of study
Method of measurement
Calculation using HOMA formula

9

Description
Thyroid hormones
Timepoint
Baseline and end of study
Method of measurement
ELISA kit

10

Description
Total antioxidant capacity
Timepoint
Baseline and end of study
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks.
Category
Treatment - Drugs

3

Description
Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diet therapy clinics affiliated to Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 0608
Fax
Email
Asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 0608
Email
mohsenta44@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taghizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Zatollah Asemi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahnaz Mahlouji
Position
Clinical Expert
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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