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Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control

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History
# Registration date Revision Id
3 2019-09-01, 1398/06/10 103874
2 2018-08-18, 1397/05/27 60471
1 2017-06-24, 1396/04/03 7704
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  • Protocol summary

    (1) Objectives: to determine and compare the effect of adding acupuncture and / or Hypericum perforatum to standard treatment on weight and appetite (2) Design: Randomized, triple blind, placebo-controlled, single-center, phase 3 trial (3) Setting and conduct : 88 overweight or obese patients will be randomly assigned to one of four groups to be treated for 8 weeks: 1. Acupuncture + Hypericum perforatum + standard diet; 2. acupuncture + placebo Hypericum perforatum + diet; 3. Sham acupuncture + Hypericum perforatum + diet; 4. sham acupuncture + placebo Hypericum perforatum+ diet (4) Participants People with BMI 24.9 to 39.9, women 18 years to premenopausal and men 18 to 60 years. Main exclusion criteria: 1- a disease affecting metabolism such as hypothyroidism 2- drugs affecting weight and metabolism or interfering with Hypericum perforatum 3- allergy to Hypericum perforatum or needle (5) intervention: Acupuncture, Hypericum perforatum, standard diet of obesity (6) main outcome measures: the appetite, anthropometric parameters, body composition, Nesfatin 1 levels, insulin levels, fasting blood sugar, side effects
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    (1) هدف مطالعه: تعیین و مقایسه اثر افزودن طب سوزنی و/یا هوفاریقون به درمان استاندارد در کاهش وزن و اشتها (2) طراحي: تصادفي، دوسويه كور، كنترل با دارو نما، تک مركزي، مرحله 3 كارآزمايي (3) نحوه انجام: 88 فرد مبتلا به چاقی یا اضافه وزن به طور تصادفی در یکی از 4 گروه زیر قرار گرفته و به مدت 8 هفته تحت درمان قرار خواهندگرفت: 1- طب سوزنی + هوفاریقون + رژیم استاندارد چاقی، 2- طب سوزنی + پلاسبوی هوفاریقون + رژیم ، 3- طب سوزنی شم+ هوفاریقون+ رژیم، 4- طب سوزنی شم+ پلاسبوی هوفاریقون+ رژیم (4) شرکت کنندگان: افراد دارای شاخص توده بدنی 24.9 تا 39.9 ، خانم های 18 ساله تا پره منوپوز و آقایان 18 تا 60 سال. معیارهای اصلی خروج از مطالعه: 1- داشتن بیماریهای موثر بر متابولیسم مانند هیپوتیروئیدی 2- مصرف داروهای موثر بر وزن و متابولیسم یا دارای تداخل با هوفاریقون 3- حساسیت به هوفاریقون یا سوزن (5) مداخلات: طب سوزنی، هوفاریقون، رژیم استاندارد چاقی (6) متغیرهای پيامد اصلی: میزان اشتها، شاخص های آنتروپومتریک، ترکیب بدن، سطح نسفاتین 1، سطح انسولین، قند خون ناشتا، عوارض جانبی
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    To determine and compare the effect of adding acupuncture and / or Hypericum perforatum to life style modification in appetite and weight control
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    تعیین و مقایسه اثر افزودن طب سوزنی و/یا هوفاریقون به تغییر شیوه زندگی در کاهش اشتها و وزن
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    A randomized, sham controlled, parallel group, phase III clinical trial with blinded patients, nutritionist, outcome assessor and statistician
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    کارآزمایی بالینی تصادفي شده، دارای گروه كنترل شم، با گروه های موازی، فاز 3 كارآزمايي، با كورسازی بیمار، متخصص تغذیه، پرسشگر و تحلیلگر آماری
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    Eighty-eight overweight or obese patients with appetite score ≤ 5 out of 10 will be randomly assigned to one of four groups to be treated for 6 weeks in the acupuncture and nutrition clinics affiliated to Mashhad University of Medical Sciences. Patients, nutritionist, outcome assessor and statistician will be blinded to study groups. acupuncturist could not be blinded in this study.
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    88 فرد مبتلا به چاقی یا اضافه وزن با اشتهای حداقل 5 از 10، به طور تصادفی در یکی از 4 گروه مطالعه قرار گرفته و به مدت 6 هفته در درمانگاه های طب سوزنی و تغذیه وابسته به دانشگاه علوم پزشکی مشهد تحت درمان قرار خواهندگرفت. بیماران، متخصص تغذیه، پرسشگر و تحلیلگر آماری نسبت به گروههای مطالعه کور خواهند بود. در این مطالعه، امکان کورسازی متخصص طب سوزنی وجود ندارد.
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    Main inclusion criteria: People with BMI 24.9 to 39.9; women 18 years to premenopausal and men 18 to 60 years. Main exclusion criteria: 1- ِdiseases affecting metabolism such as hypothyroidism 2- drugs affecting weight and metabolism or interfering with Hypericum perforatum 3- allergy to hypericum perforatum or metal
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    شرایط عمده ورود: افراد دارای شاخص توده بدنی 24.9 تا 39.9 ، خانم های 18 ساله تا پره منوپوز و آقایان 18 تا 60 سال. شرایط عمده عدم ورود: 1- داشتن بیماریهای موثر بر متابولیسم مانند هیپوتیروئیدی 2- مصرف داروهای موثر بر وزن و متابولیسم یا دارای تداخل با هوفاریقون 3- حساسیت به هوفاریقون یا فلز
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    1. Acupuncture + Hypericum perforatum + life style modification; 2. acupuncture + placebo + life style modification; 3. Sham acupuncture + Hypericum perforatum + life style modification; 4. sham acupuncture + placebo + life style modification
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    1- طب سوزنی + هوفاریقون + تغییر شیوه زندگی؛ 2- طب سوزنی + پلاسبو + تغییر شیوه زندگی؛ 3- طب سوزنی شم+ هوفاریقون+ تغییر شیوه زندگی؛ 4- طب سوزنی شم+ پلاسبو + تغییر شیوه زندگی
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    Nesfatin 1 levels؛ the appetite score; BMI; waist circumference; hip circumference; body composition
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    سطح نسفاتین 1؛ میزان اشتها؛ شاخص توده بدنی؛ دور کمر؛ دور هیپ؛ ترکیب بدن

  • General information

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    2017-06-22, 1396/04/01
    2017-10-23, 1396/08/01
    2017-10-23, 1396/08/01
    2018-10-23, 1397/08/01
    Comparison of acupuncture, Hypericum Perforatum and standard treatment in weight loss
    The effect of acupuncture, hypericum perforatum and diet in appetite and weight control
    مقایسه طب سوزنی، درمان گیاهی و رژیم غذایی در کاهش وزن
    اثر طب سوزنی، گیاه و رژیم غذایی در کنترل اشتها و وزن
    Comparison of Integrative Medicine (acupuncture, Hypericum Perforatum and standard treatment) with standard therapy in weight loss: a randomized controlled clinical trial
    Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control
    مقايسه درمان طب تلفيقي (طب سوزنی، گیاه هوفاریقون و درمان استاندارد) با درمان استاندارد در کاهش وزن: يک کارآزمايي باليني کنترل دار تصادفي شده
    مقايسه درمان طب تلفيقي (طب سوزنی، گیاه هوفاریقون و تغییر شیوه زندگی) با تغییر شیوه زندگی در کنترل اشتها و وزن
    Appetite score more than 4 according to visual analogue scale
    Body mass index between 24.9 to 39.9
    Women 18 years old to pre-menopause; men 18 to 60 years old
    Failure to life style modification alone
    "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation
    اسکور اشتهای بیشتر از 4 بر اساس مقیاس دیداری
    شاخص توده بدنی 24.9 تا 39.9
    خانم های 18 ساله تا پره منوپوز؛ آقایان 18 تا 60 سال
    شکست در تغییر شیوه زندگی به تنهایی
    سندرم "رکود چی کبدی" بر اساس سندرم شناسی طب چینی
    Hypothyroidism, Cushing's syndrome, cancer, liver or kidney failure
    Using drugs effective on appetite, weight and metabolism in the previous month
    Using drugs that interfere with Hypericum perforatum such as protease inhibitors, amiodarone, anticoagulants, cyclophosphamide, cyclosporine, monoamine oxidase inhibitors, phenytoin, tacrolimus, tamoxifen and trazodone drug
    Drug abuse or alcoholism
    Breast-feeding, pregnancy or planning a pregnancy during the next two months
    Having pacemaker or any other metal device inside the body due to the use of electroacupuncture and Bioelectrical Impedance Analyzer
    disability to do recommended physical activity
    Allergy to Hypericum perforatum or metal
    Coagulation disorders
    History of receiving acupuncture
    هیپوتیروئیدی، سندرم کوشینگ، بدخیمی، نارسایی کبد و کلیه
    مصرف داروهای موثر بر اشتها، وزن و متابولیسم در ماه گذشته
    مصرف داروهایی که با هوفاریقون تداخل دارند مانند مهارگرهای پروتئاز، آمیودارون، داروهای ضد انعقاد، سیکلوفسفامید، سیکلوسپورین، مهارگرهای مونوآمینواکسیداز، فنی توئین، تاکرولیموس، تاموکسیفن و ترازودون
    مصرف مواد مخدر یا الکل
    شیردهی و حاملگی یا قصد بارداری در طی دو ماه آینده
    داشتن پیس میکر و هر گونه وسیله فلزی در داخل بدن به دلیل استفاده از دستگاه بایوالکتریکال امپدانس آنالیزور و الکترواکوپانکچر
    عدم توانایی بر انجام فعالیت بدنی توصیه شده
    حساسیت به هوفاریقون یا فلز
    اختلالات انعقادی
    سابقه دریافت طب سوزنی
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    Block randomization will be done using SPSS version 16 by selecting quadrants blocks.
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    تصادفی سازی به روش بلوک با نرم افزار اس پی اس اس نسخه 16با انتخاب بلوک های چهارتایی انجام خواهد شد.
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    Participants, the nutritionist, the outcome assessor, and the statistician will be blinded from the identity of the study groups. The acupuncturist will not be blinded. The participant blindness will be performed using sham acupuncture and placebo.
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    شرکت کنندگان، متخصص تغذیه، ارزیابی کننده پیامدها، و متخصص آمار نسبت به ماهیت گروههای مطالعه کور خواهند بود. متخصص طب سوزنی کور نخواهد بود. کورسازی شرکت کنندگان با استفاده از شم اکوپانکچر و پلاسبو انجام خواهد شد.

  • Primary outcomes

    #1
    waist to hip ratio
    Plasma nesfatin-1
    نسبت دور کمر به هیپ
    سطح پلاسمایی نسفاتین 1
    before intervention, week 4, week 8
    Before intervention, Sixth week
    قبل از مداخله، در هفته چهار و هشت
    قبل از مداخله، هفته 6
    Centimeter
    Laboratory: ELISA
    سانتی متر
    آزمایشگاهی به روش الایزا
    #2
    appetite
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    اشتها
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    before intervention, week 4, week 8
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    قبل از مداخله، در هفته چهار و هشت
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    Visual Analogue Scale
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    مقیاس دیداری
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    #3
    body weight
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    وزن بدن
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    before intervention, week 4, week 8
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    قبل از شروع مداخله، هفته 4 و 8
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    Kilogram
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    کیلوگرم
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  • Secondary outcomes

    #1
    Nesfatin-1
    Appetite score
    سطح نسفاتین 1
    نمره اشتها
    before intervention, after intervention
    Before intervention, weeks 2, 4, 6, 24
    قبل از شروع مداخله، بعد از پایان مداخله
    قبل از شروع مداخله، در هفته 2، 4، 6، 24
    ng/dl
    Visual Analogue Scale
    نانوگرم بر دسی لیتر
    مقیاس دیداری
    #2
    Insulin
    Body Mass Index
    انسولین
    شاخص توده بدنی
    before intervention, after intervention
    Before intervention, weeks 2, 6, 24
    قبل از شروع مداخله، بعد از پایان مداخله
    قبل از شروع مداخله، هفته 2، 6 و 24
    IU
    Using the bioelectrical impedance analyzer; kg/m2
    واحد بین المللی
    با استفاده از دستگاه آنالیز بدن؛ بر حسب کیلوگرم بر متر مربع
    #3
    Fasting Blood Sugar
    Waist circumference
    قند خون ناشتا
    دور کمر
    before intervention, after intervention
    Before intervention, weeks 2, 6, 24
    قبل از شروع مداخله، بعد از پایان مداخله
    قبل از شروع مداخله، هفته 2، 6 و 24
    mg/dl
    Using a tape measure; centimeters
    میلی گرم بر دسی لیتر
    با استفاده از متر نواری؛ بر حسب سانتی متر
    #4
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    Hip circumference
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    دور هیپ
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    Before intervention, weeks 2, 6, 24
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    قبل از شروع مداخله، هفته 2، 6 و 24
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    Using a tape measure; centimeters
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    با استفاده از متر نواری؛ بر حسب سانتی متر
    #5
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    Body composition
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    ترکیب بدن
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    Before intervention, weeks 2, 6
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    قبل از شروع مداخله، هفته 2 و 6
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    Using the bioelectrical impedance analyzer
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    با استفاده از دستگاه آنالیز بدن
    #6
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    Lipid profile
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    پروفایل لیپیدی
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    Before intervention, week 6
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    قبل از شروع مداخله، هفته 6
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    Laboratory
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    آزمایشگاهی
    #7
    empty
    Liver enzymes
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    آنزیم های کبدی
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    Before intervention, week 6
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    قبل از شروع مداخله، هفته 6
    empty
    Laboratory
    empty
    آزمایشگاهی
    #8
    empty
    Blood glucose level
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    سطح قند خون
    empty
    Before intervention, week 6
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    قبل از شروع مداخله، هفته 6
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    Laboratory
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    آزمایشگاهی
    #9
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    Adverse events
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    عوارض جانبی
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    During the study period within 48 to 72 hours of incidence; week 6
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    در طول مطالعه در فاصله 48 تا 72 ساعت از زمان بروز؛ هفته 6
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    Study checklist
    empty
    چک لیست مطالعه

  • Intervention groups

    #1
    Acupuncture, 3 times per week + Perforan tab, 15 mg/kg/day + diet for 8 weeks
    Intervention group 1: acupuncture, 3 times per week + 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
    طب سوزنی، سه بار در هفته + قرص پرفوران ، 15 mg/kg روزانه + رژیم غذایی به مدت هشت هفته
    گروه مداخله 1: طب سوزنی، سه بار در هفته + 4 عدد کپسول هوفاریقون در روز (معادل 400 میلی گرم عصاره در روز) + تغییر شیوه زندگی به مدت 6 هفته
    #2
    Sham acupuncture, 3 times/week+Perforan tab, 15 mg/kg/day, for 8 weeks + diet for 8 weeks
    Intervention group 2: acupuncture 3 times/week + placebo capsules + life style modification for 6 weeks
    طب سوزنی شم، 3 بار در هفته + قرص پرفوران 15 mg/kg روزانه + رژیم غذایی به مدت 8 هفته
    گروه مداخله 2: طب سوزنی، 3 بار در هفته+ کپسول پلاسبو + تغییر شیوه زندگی به مدت 6 هفته
    #3
    acupuncture 3 times/week + Perforan placebo tab + diet for 8 weeks
    Intervention group 3: sham acupuncture, 3 times/week+ 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
    طب سوزنی، 3 بار در هفته+ پلاسبوی پرفوران+ رژیم غذایی به مدت 8 هفته
    گروه مداخله 3: طب سوزنی شم، 3 بار در هفته + 4 عدد کپسول هوفاریقون در روز (معادل 400 میلی گرم عصاره در روز) + تغییر شیوه زندگی به مدت 6 هفته
    #4
    Other
    Lifestyle
    Sham acupuncture, 3 times/week + Perforan placebo tab + diet for 8 weeks
    Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks
    طب سوزنی شم ، سه بار در هفته + پلاسبوی پرفوران + رژیم غذایی به مدت 8 هفته
    گروه کنترل: طب سوزنی شم ، سه بار در هفته + پلاسبو + رژیم غذایی به مدت 6 هفته

  • Recruitment centers

    #1
    Name of recruitment center - English: Acupuncture clinic, Imam Reza Hospital
    Name of recruitment center - Persian: درمانگاه طب سوزنی بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Street address - English: Daneshgah Street
    Street address - Persian: خیابان دانشگاه
    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: Acupuncture clinic, Imam Reza Hospital
    Name of recruitment center - Persian: درمانگاه طب سوزنی بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Street address - English: Daneshgah Street
    Street address - Persian: خیابان دانشگاه
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3802 2035
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Nutrition clinic, Qaem Hospital
    Name of recruitment center - Persian: درمانگاه تغذیه بیمارستان قائم
    Full name of responsible person - English: Dr. Mohammad Safarian
    Full name of responsible person - Persian: دکتر محمد صفریان
    Street address - English: Ahmadabad Street, Mashhad, Iran
    Street address - Persian: خیابان احمدآباد، مشهد، ایران
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9919991766
    Phone: +98 51 3845 3239
    Fax:
    Email: safarianm@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Mashhad University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Qorashi Building, Daneshgah Street
    Street address - Persian: خیابان دانشگاه، ساختمان قرشی
    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 Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Qorashi Building, Daneshgah Street
    Street address - Persian: خیابان دانشگاه، ساختمان قرشی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91357345
    Phone: +98 51 3841 2081
    Fax:
    Email: tafaghodim@mums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل مشهد
    Full name of responsible person - English: Dr. Monirsadat Sahebkar Khorasani
    Full name of responsible person - Persian: دکتر منیر سادات صاحبکار خراسانی
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pardis daneshgah, Park Square
    Street address - Persian: پردیس دانشگاه، میدان پارک
    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 4212
    Mobile: 00
    Fax:
    Email: sahebkarm931@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل مشهد
    Full name of responsible person - English: Dr. Monirsadat Sahebkar Khorasani
    Full name of responsible person - Persian: دکتر منیر سادات صاحبکار خراسانی
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: med_doctor
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pardis daneshgah, Park Square
    Street address - Persian: پردیس دانشگاه، میدان پارک
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3882 9279
    Mobile: +98 915 325 6898
    Fax:
    Email: sahebkarm931@mums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل، دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Position - English: Assistant Professor
    Position - Persian: استادیار دانشگاه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Azadi Square
    Street address - Persian: میدان آزادی
    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 3882 9279
    Mobile: 00
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل، دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Position - English: Assistant Professor
    Position - Persian: استادیار دانشگاه
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: acupuncture and Chinese Medicine
    Area of specialty/work title - Persian: طب سوزنی و چینی
    Street address - English: Azadi Square
    Street address - Persian: میدان آزادی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3882 9279
    Mobile: +98 915 313 7194
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل
    Full name of responsible person - English: Dr. Monirsadat Sahebkar-khorasani
    Full name of responsible person - Persian: دکتر منیرسادات صاحبکار خراسانی
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Park Square
    Street address - Persian: میدان پارک
    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 4212
    Mobile: 00
    Fax:
    Email: sahebkarm931@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: School of Traditional and Complementary Medicine
    Name of organization / entity - Persian: دانشکده طب سنتی و مکمل
    Full name of responsible person - English: Dr. Monirsadat Sahebkar-khorasani
    Full name of responsible person - Persian: دکتر منیرسادات صاحبکار خراسانی
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: med_doctor
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Park Square
    Street address - Persian: میدان پارک
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177948564
    Phone: +98 51 3882 9279
    Mobile: +98 915 325 6898
    Fax:
    Email: sahebkarm931@mums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    There is no more information.
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
To determine and compare the effect of adding acupuncture and / or Hypericum perforatum to life style modification in appetite and weight control
Design
A randomized, sham controlled, parallel group, phase III clinical trial with blinded patients, nutritionist, outcome assessor and statistician
Settings and conduct
Eighty-eight overweight or obese patients with appetite score ≤ 5 out of 10 will be randomly assigned to one of four groups to be treated for 6 weeks in the acupuncture and nutrition clinics affiliated to Mashhad University of Medical Sciences. Patients, nutritionist, outcome assessor and statistician will be blinded to study groups. acupuncturist could not be blinded in this study.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: People with BMI 24.9 to 39.9; women 18 years to premenopausal and men 18 to 60 years. Main exclusion criteria: 1- ِdiseases affecting metabolism such as hypothyroidism 2- drugs affecting weight and metabolism or interfering with Hypericum perforatum 3- allergy to hypericum perforatum or metal
Intervention groups
1. Acupuncture + Hypericum perforatum + life style modification; 2. acupuncture + placebo + life style modification; 3. Sham acupuncture + Hypericum perforatum + life style modification; 4. sham acupuncture + placebo + life style modification
Main outcome variables
Nesfatin 1 levels؛ the appetite score; BMI; waist circumference; hip circumference; body composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201706107265N9
Registration date: 2017-06-24, 1396/04/03
Registration timing: prospective

Last update: 2018-09-24, 1397/07/02
Update count: 2
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control
Public title
The effect of acupuncture, hypericum perforatum and diet in appetite and weight control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Appetite score more than 4 according to visual analogue scale Body mass index between 24.9 to 39.9 Women 18 years old to pre-menopause; men 18 to 60 years old Failure to life style modification alone "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation
Exclusion criteria:
Hypothyroidism, Cushing's syndrome, cancer, liver or kidney failure Using drugs effective on appetite, weight and metabolism in the previous month Using drugs that interfere with Hypericum perforatum such as protease inhibitors, amiodarone, anticoagulants, cyclophosphamide, cyclosporine, monoamine oxidase inhibitors, phenytoin, tacrolimus, tamoxifen and trazodone drug Drug abuse or alcoholism Breast-feeding, pregnancy or planning a pregnancy during the next two months Having pacemaker or any other metal device inside the body due to the use of electroacupuncture and Bioelectrical Impedance Analyzer disability to do recommended physical activity Allergy to Hypericum perforatum or metal Coagulation disorders History of receiving acupuncture
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using SPSS version 16 by selecting quadrants blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, the nutritionist, the outcome assessor, and the statistician will be blinded from the identity of the study groups. The acupuncturist will not be blinded. The participant blindness will be performed using sham acupuncture and placebo.
Placebo
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 Sciences
Street address
Qorashi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.MUMS.REC.1396.43

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Plasma nesfatin-1
Timepoint
Before intervention, Sixth week
Method of measurement
Laboratory: ELISA

Secondary outcomes

1

Description
Appetite score
Timepoint
Before intervention, weeks 2, 4, 6, 24
Method of measurement
Visual Analogue Scale

2

Description
Body Mass Index
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using the bioelectrical impedance analyzer; kg/m2

3

Description
Waist circumference
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using a tape measure; centimeters

4

Description
Hip circumference
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using a tape measure; centimeters

5

Description
Body composition
Timepoint
Before intervention, weeks 2, 6
Method of measurement
Using the bioelectrical impedance analyzer

6

Description
Lipid profile
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

7

Description
Liver enzymes
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

8

Description
Blood glucose level
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

9

Description
Adverse events
Timepoint
During the study period within 48 to 72 hours of incidence; week 6
Method of measurement
Study checklist

Intervention groups

1

Description
Intervention group 1: acupuncture, 3 times per week + 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
Category
Other

2

Description
Intervention group 2: acupuncture 3 times/week + placebo capsules + life style modification for 6 weeks
Category
Other

3

Description
Intervention group 3: sham acupuncture, 3 times/week+ 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
Category
Other

4

Description
Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Acupuncture clinic, Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2035
Email
azizih@mums.ac.ir

2

Recruitment center
Name of recruitment center
Nutrition clinic, Qaem Hospital
Full name of responsible person
Dr. Mohammad Safarian
Street address
Ahmadabad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3845 3239
Email
safarianm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qorashi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 2081
Email
tafaghodim@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 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
School of Traditional and Complementary Medicine
Full name of responsible person
Dr. Monirsadat Sahebkar Khorasani
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Pardis daneshgah, Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
sahebkarm931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
acupuncture and Chinese Medicine
Street address
Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
azizih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional and Complementary Medicine
Full name of responsible person
Dr. Monirsadat Sahebkar-khorasani
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
sahebkarm931@mums.ac.ir
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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