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# Registration date Revision Id
2 2022-01-26, 1400/11/06 217229
1 2016-07-09, 1395/04/19 22367
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  • Protocol summary

    (1) Objectives: To determine the efficacy of a special food (fried egg with grape molasses) on threatened abortion. (2) Design: A randomized controlled Phase 2 single-blind clinical trial. (3) Setting and conduct: 90 pregnant women with threatened abortion (n = 45 per group), with mild to moderate severity of vaginal bleeding and gestational age below 12 weeks, coming to Childbirth Emergency or Perinatology clinic of ValiAsr Hospital or Traditional Iranian Medicine clinic of Tehran University of Medical Sciences. They are placed randomly into two groups: control (routine of threatened abortion) and intervention (dietary consumption of egg with grape molasses+ routine management of threatened abortion). (4) Participants: Pregnant women with threatened abortion issue with mild to moderate severity of vaginal bleeding, gestational age below 12 weeks, after confirming the ultrasound and the absence of exclusion criteria (mother systemic illness, history of recurrent miscarriage, Open cervix more than two centimeters, absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks GA, incomplete abortion, missed abortion or multiple gestation sacs in ultrasound) are enrolled. (5) Interventions: In the control group, intravaginal Cyclogest 200 mg daily, bed rest at home and abstinence from sexual intercourse until vaginal bleeding is stopped; then Cyclogest prescribed every other day until one week. In the intervention group, In addition to routine management, the special food of fried egg with grape molasses will be given to patients. The other conditions of intervention group, including the duration of eating this food, are similar to the control group. (6) Main outcome measures: The primary outcome of this study is determine the miscarriage rate (loss of an intrauterine pregnancy at ≤20 week’s gestation) in patients with threatened abortion. Secondary outcome is the average duration of vaginal bleeding.
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    (1) اهداف: تعیین اثربخشی مصرف خوراکی تخم مرغ با شیره انگور بر تهدید به سقط. (2) طراحی: کارآزمایی بالینی کنترل شده تصادفی فاز 2 یک سو کور. (3) نحوه انجام: تعداد 90 خانم باردار با مشکل تهدید به سقط (45 نفر در هر گروه) با شدت خونریزی واژینال خفیف تا متوسط و سن حاملگی زیر 12 هفته که به اورژانس زایمان یا درمانگاه مامایی بیمارستان ولیعصر (عج) و یا درمانگاه های طب سنتی دانشگاه علوم پزشکی تهران مراجعه می کنند، به صورت تخصیص تصادفی در دو گروه کنترل (درمان روتین تهدید به سقط) و گروه مداخله (مصرف خوراکی تخم مرغ با شیره انگور+ درمان روتین تهدید به سقط) قرار می گیرند. (4) شرکت کنندگان: خانم های باردار با مشکل تهدید به سقط با شدت خونریزی واژینال خفیف تا متوسط و سن حاملگی زیر 12 هفته، پس از تایید سونوگرافی و عدم وجود معیار خروج (بیماری سیستمیک مادر؛ سابقه سقط راجعه؛ باز بودن دهانه رحم بیشتر از دو سانتی متر، فقدانِ ساک حاملگی طبیعی در هفته 5، کیسه زرده یا فعالیت قلبی در هفته 7، سقط ناکامل، سقط فراموش شده و حاملگی چندقلویی در سونوگرافی) وارد مطالعه می شوند. (5) مداخلات: در گروه کنترل، شیاف سیکلوژست 200، روزانه به همراه استراحت نسبی و همچنین منع نزدیکی جنسی تجویز می گردد و تا زمان قطع خونریزی ادامه می یابد و تا یک هفته پس از اتمام خونریزی، شیاف یک روز در میان تجویز می گردد. در گروه مداخله، علاوه بر شیاف سیکلوژست، روش تهیه تخم مرغ با شیره انگور، به بیماران داده می شود. بقیه شرایط گروه مداخله، از جمله مدت مصرف تخم مرغ، مشابه گروه کنترل است. (6) متغیر های پیامد اصلی: پیامد اولیه مورد نظر در این مطالعه، تعیین میزان سقط (از دست دادن جنین تا هفته بیستم حاملگی)، در بیماران تهدید به سقط می باشد. پیامد ثانویه نیز میانگین مدت خونریزی واژینال می باشد.
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    To determine the efficacy of a special food (fried egg with grape molasses) on threatened abortion.
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    تعیین اثربخشی مصرف خوراکی تخم مرغ با شیره انگور بر تهدید به سقط.
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    A randomized controlled clinical trial
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    کارآزمایی بالینی کنترل شده تصادفی
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    90 patients will include in the study. Participants of this study were selected from the women referring to the perinatology clinic of Vali-asr hospital and Persian medicine clinic of Tehran University of Medical Sciences, with mild or moderate vaginal hemorrhage up to 16 wk.
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    تعداد 90 خانم باردار با مشکل تهدید به سقط، با شدت خونریزی واژینال خفیف تا متوسط و سن حاملگی زیر 16 هفته که به اورژانس زایمان یا درمانگاه مامایی بیمارستان ولیعصر (عج) و یا درمانگاه طب سنتی دانشگاه علوم پزشکی تهران مراجعه می کنند، به صورت تخصیص تصادفی در دو گروه کنترل (درمان روتین تهدید به سقط) و گروه مداخله (مصرف خوراکی تخم مرغ با شیره انگور+ درمان روتین تهدید به سقط) قرار می گیرند.
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    Pregnant women with threatened abortion issue with mild to moderate severity of vaginal bleeding, gestational age below 16 weeks, after confirming the ultrasound and the absence of exclusion criteria (mother systemic illness, history of recurrent miscarriage, Open cervix more than two centimeters, absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks GA, incomplete abortion, missed abortion or multiple gestation sacs in ultrasound) are enrolled.
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    خانم های باردار با مشکل تهدید به سقط با شدت خونریزی واژینال خفیف تا متوسط و سن حاملگی زیر 16 هفته، پس از تایید سونوگرافی و عدم وجود معیار خروج (بیماری سیستمیک مادر؛ سابقه سقط راجعه؛ باز بودن دهانه رحم بیشتر از دو سانتی متر، فقدانِ ساک حاملگی طبیعی در هفته 5، کیسه زرده یا فعالیت قلبی در هفته 7، سقط ناکامل، سقط فراموش شده و حاملگی چندقلویی در سونوگرافی) وارد مطالعه می شوند.
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    1- The control group received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between. 2- The intervention group received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week.
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    در گروه کنترل، شیاف سیکلوژست 400، روزانه به همراه استراحت نسبی و همچنین منع نزدیکی جنسی تجویز می گردد و تا 3 روز پس از قطع خونریزی ادامه می یابد. سپس تا یک هفته، شیاف یک روز در میان تجویز می گردد. در گروه مداخله، علاوه بر درمان روتین، تخم مرغ با شیره انگور، به بیماران داده می شود. مدت مصرف غذا، مانند تجویز شیاف است (مصرف روزانه غذا تا 2 روز بعد از قطع خونریزی، سپس ادامه آن یک روز در میان، تا یک هفته پس از اتمام خونریزی). ضمنا روش تهیه تخم مرغ با کره حیوانی و شیره انگور به گروه مداخله داده می شود
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    the event of pregnancy losses before 20 weeks in both study arms
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    تعیین رخداد از دست دادن جنین زیر 20 هفته در هر دو گروه مطالعه
  • General information

    Single blinded
    Not blinded
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    3
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    2016-07-22, 1395/05/01
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    2018-11-01, 1397/08/10
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    2018-11-01, 1397/08/10
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    Some changes in the method and study date
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    بعضی تغییرات در روش اجرا و تاریخ پایان مطالعه
    The efficacy of a special food (fried egg with grape molasses) on threatened abortion: a randomized controlled trial
    The Effects of a Special Food (Fried Eggs with Grape Molasses) on Threatened Miscarriage in Combination with Conventional Therapies: A Randomized Clinical Trial
    بررسی اثربخشی مصرف غذایی تخم مرغ با شیره انگور در تهدید به سقط: کارآزمایی بالینی کنترل شده تصادفی
    بررسی اثربخشی مصرف غذایی تخم مرغ با شیره انگور در تهدید به سقط در ترکیب با درمان های رایج: کارآزمایی بالینی کنترل شده تصادفی
    Pregnant women presenting with mild to moderate vaginal bleeding (using 2 Pads or less per day)
    Up to 16 weeks of pregnancy
    Normal ultrasound (including a normal gestational sac at five wk of gestation, yolk sac at six wk, or fetal heart activity at seven wk of gestation or later)
    Closed cervix in vaginal examination
    Singleton pregnancy
    Having consent to participate in the study
    Tendency to consume this special food (in intervention group)
    No fried eggs with grape molasses in routine diet food
    خانم های باردار با مشکل تهدید به سقط، با شدت خونریزی واژینال خفیف تا متوسط (استفاده از 2 پد یا کمتر در روز)
    سن حاملگی زیر 16 هفته
    سونوگرافی طبیعی (شامل مشاهده ساک حاملگی طبیعی در هفته 5، یا کیسه زرده در هفته 6، یا فعالیت قلبی طبیعی در هفته 7 بارداری یا دیرتر)
    بسته بودن دهانه رحم در معاینه واژینال
    حاملگی تک قلویی
    دارای رضایت جهت شرکت در مطالعه
    تمایل به مصرف این نوع غذا (گروه مداخله)
    عدم مصرف تخم مرغ با شیره انگور در برنامه روتین غذایی.
    Mother systemic illness such as fever, diabetes, chronic hypertension
    History of recurrent miscarriage
    Heavy vaginal bleeding (>2 pads soaked)
    Loss of conception tissue
    Open cervix (>2 centimeters) in vaginal examination
    Cervical lesions such as polyps or cervicitis
    Abnormal findings on ultrasound (absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks gestational age, incomplete abortion, missed abortion)
    Multiple gestation sacs
    Molar pregnancy
    Fetal or uterine anomalies
    Allergy or intolerance to eggs, grape molasses or progesterone
    The patient withdrew from the study
    بیماری سیستمیک مادر مثـل تب، دیابت، افزایش فشارخون مزمن
    سابقه سقط راجعه
    خونریزی شدید (استفاده بیشتر از 2 پد در روز)
    دفع هرگونه بافت جنینی یا حاملگی
    باز بودن دهانه رحم بیشتر از دو سانتی متر در معاینه واژینال
    یافته غیرطبیعی در سونوگرافی (فقدانِ ساک حاملگی طبیعی در هفته 5، کیسه زرده یا فعالیت قلبی در هفته 7، سقط ناکامل، سقط فراموش شده)
    حاملگی چندقلویی
    مول هیداتیفورم
    آنومالی جنینی یا رحمی
    ضایعات سرویکس مانند پولیپ یا زخم
    آلرژی یا عدم تحمل تخم مرغ، شیره انگور یا پروژسترون
    انصراف بیمار از شرکت در مطالعه.
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    Blocks of six subjects carried out randomization and treatments’ allocation with using stata software version 13. The list of random allocation of patients will be available only to the epidemiologist.
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    روش تخصیص تصادفی، بلوکی بوده که با استفاده از نرم افزار stata ورژن 13، توسط همکار اپیدمیولوژیست طراحی شد. تعداد بلوک های در نظر گرفته شده 6 تایی است. لیست تخصیص تصادفی بیماران صرفاً در اختیار اپیدمیولوژیست طرح خواهد بود.
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  • Primary outcomes

    #1
    تعیین میزان سقط (از دست دادن جنین تا هفته بیستم حاملگی)، در بیماران تهدید به سقط
    تعیین میزان سقط (رخداد از دست دادن جنین تا هفته بیستم حاملگی)، در بیماران تهدید به سقط
  • Intervention groups

    #1
    Treatment - Other
    Treatment - Drugs
    Intervention group: In addition to intravaginal Cyclogest, the food recipe of fried eggs with butter and grape molasses will be given to patients. The other conditions of intervention group, including the duration of eating this food, are similar to the control group.
    Control group: They received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between.
    در گروه مداخله علاوه بر شیاف سیکلوژست، استراحت نسبی و منع نزدیکی جنسی، غذای مذکور نیز تجویز می شود. مدت مصرف غذا، مانند تجویز شیاف است (مصرف روزانه غذا تا قطع خونریزی، سپس ادامه آن یک روز در میان، تا یک هفته پس از اتمام خونریزی). ضمنا روش تهیه تخم مرغ با کره حیوانی و شیره انگور به گروه مداخله داده می شود
    گروه کنترل: درمان روتین تهدید به سقط، یعنی شیاف سیکلوژست 400 روزانه به همراه استراحت نسبی و همچنین منع نزدیکی جنسی، تجویز می گردد و تا 3 روز پس از قطع خونریزی ادامه می یابد. سپس تا یک هفته، شیاف یک روز در میان تجویز می گردد.
    #2
    Control group: Cyclogest (intravaginal progesterone) 200 mg daily, bed rest at home and abstinence from sexual intercourse until vaginal bleeding is stopped; then cyclogest prescribed every other day until one week.
    Intervention group: They received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week. "Khagineh Recipe: Beat together one egg and 25 g of grape molasses with salt until blended. Heat 5 g of pasteurized cow butter in a pan until it becomes hot. Pour the blended eggs onto the pan and brown on both sides."
    در گروه کنترل، شیاف سیکلوژست 200، روزانه به همراه توصیه به استراحت نسبی و همچنین منع نزدیکی جنسی تجویز می گردد. این دستورات، تا زمان قطع خونریزی ادامه می یابد و سپس تا یک هفته پس از اتمام خونریزی، یک روز در میان تجویز می گردد.
    گروه مداخله: علاوه بر درمان روتین، تخم مرغ با شیره انگور، به بیماران داده می شود. مدت مصرف غذا، مانند تجویز شیاف است (مصرف روزانه غذا تا 2 روز بعد از قطع خونریزی، سپس ادامه آن یک روز در میان، تا یک هفته پس از اتمام خونریزی). ضمنا روش تهیه تخم مرغ با کره حیوانی و شیره انگور به گروه مداخله داده می شود: «یک عدد تخم‌مرغ و 25 گرم شیره انگور را با اندکی نمک در ظرفی جدا، هم بزنید تا مخلوط شوند. 5 گرم کره گاو پاستوریزه را در تابه گرم کنید. سپس مخلوط تخم مرغ را در تابه بریزید و دو طرف آن را سرخ کنید».
  • Recruitment centers

    #1
    Name of recruitment center - English: Childbirth Emergency of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
    Name of recruitment center - Persian: اورژانس زایمان بیمارستان ولیعصر (عج)، مجتمع بیمارستانی امام خمینی، دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Street address - English: Imam Khomeini Hospital Complex, End of Keshavarz Blv,
    Street address - Persian: انتهای بلوار کشاورز. مجتمع بیمارستانی امام خمینی. بیمارستان ولیعصر
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Perinatology clinic of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
    Name of recruitment center - Persian: درمانگاه پریناتولوژی بیمارستان ولیعصر (عج)، بیمارستان امام خمینی
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Street address - English: Imam Khomeini Hospital Complex, End of Keshavarz Blv,
    Street address - Persian: انتهای بلوار کشاورز. مجتمع بیمارستانی امام خمینی. بیمارستان ولیعصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۹۷۳۳۱۴۱
    Phone: +98 21 6658 1615
    Fax:
    Email: Imamhospital@tums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Perinatology clinic of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
    Name of recruitment center - Persian: درمانگاه پریناتولوژی بیمارستان ولیعصر (عج)
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Street address - English: Imam Khomeini Hospital Complex, End of Keshavarz Blv,
    Street address - Persian: انتهای بلوار کشاورز. مجتمع بیمارستانی امام خمینی. بیمارستان ولیعصر
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Traditional Iranian Medicine Ahmadiyeh clinic, Tehran University of Medical Sciences (TUMS)
    Name of recruitment center - Persian: کلینیک طب سنتی احمدیه دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1416663361
    Phone: +98 21 6697 6527
    Fax:
    Email: dfmoradi@gmail.com
    Web page address:
    #3
    Name of recruitment center - English: Traditional Iranian Medicine clinic, Tehran University of Medical Sciences (TUMS)
    Name of recruitment center - Persian: کلینیک طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: 3. Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
    Name of organization / entity - Persian: معاونت پژوهشی دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Roja Rahimi
    Full name of responsible person - Persian: دکتر روجا رحیمی
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    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, School of Traditional medicine, Tehran University of Medical Scienc
    Name of organization / entity - Persian: معاونت پژوهشی دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Roja Rahimi
    Full name of responsible person - Persian: دکتر روجا رحیمی
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Fax:
    Email: rojarahimi@gmail.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    3. Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
    Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: School of Traditional Medicine, Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Position - English: PhD candidate of Traditional Medicine
    Position - Persian: دانشجوی پی اچ دی طب سنتی ایرانی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: +93 51979157
    Fax: +98 21 6697 6527
    Email: dfmoradi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Position - English: physician/ PhD of Traditional Medicine
    Position - Persian: پزشک/ پی اچ دی طب سنتی ایرانی/ غیر هیئت علمی
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: +98 935 197 9157
    Fax: +98 21 6697 6527
    Email: dfmoradi@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: School of Traditional medicine, Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Malieheh Tabarraie Arani
    Full name of responsible person - Persian: دکتر ملیحه تبرایی آرانی
    Position - English: PhD of Traditional Medicine
    Position - Persian: پی اچ دی طب سنتی ایرانی. استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: 00
    Fax: +98 21 6697 6527
    Email: dr.mtabarrai@yahoo.com
    Web page address: http://tim.tums.ac.ir/
    contact.organization_id:
    Name of organization / entity - English: School of Traditional medicine, Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Malieheh Tabarraie Arani
    Full name of responsible person - Persian: دکتر ملیحه تبرایی آرانی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: +98 935 197 9157
    Fax: +98 21 6697 6527
    Email: dr.mtabarrai@yahoo.com
    Web page address: http://tim.tums.ac.ir/
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Dr Fatemeh Moradi
    Name of organization / entity - Persian: دانشکده طب سنتی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Position - English: School of Traditional Medicine, Tehran University of Medical Sciences
    Position - Persian: دانشجوی پی اچ دی طب سنتی ایرانی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: PhD candidate of Traditional Medicine
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: +98 935 197 9157
    Fax: +98 21 6697 6527
    Email: dfmoradi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Fatemeh Moradi
    Full name of responsible person - Persian: دکتر فاطمه مرادی
    Position - English: physiacian/ PhD of Iranian traditional medicine
    Position - Persian: پزشک. پی اچ دی طب سنتی ایرانی. غیرهیات علمی
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
    Street address - Persian: ولیعصر. خیابان طالقانی. بعد از میدان فلسطین. خیابان سرپرست. دانشکده و کلینیک تخصصی طب سنتی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614353
    Phone: +98 21 6697 6527
    Mobile: +98 935 197 9157
    Fax: +98 21 6697 6527
    Email: dfmoradi@gmail.com
    Web page address:
  • Sharing plan

    undecided
    yes
    yes
    yes
    undecided
    undecided
    undecided
    empty
    There is no more information
    empty
    اطلاعات بیشتری وجود ندارد
    empty
    Ph.D. thesis + journal article
    empty
    در متن رساله دکتری تخصصی + مقاله کارآزمایی بالینی مطالعه
    empty
    five years
    empty
    پنج سال
    empty
    Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
    empty
    مراجعه کنندگان به کتابخانه دانشکده طب سنتی د ع پ تهران + مراجعه کنندگان به سایت مجله
    empty
    Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
    empty
    مراجعه کنندگان به کتابخانه دانشکده طب سنتی د ع پ تهران + مراجعه کنندگان به سایت مجله
    empty
    Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
    empty
    مراجعه کنندگان به کتابخانه دانشکده طب سنتی د ع پ تهران + مراجعه کنندگان به سایت مجله
    empty
    A common process in the libraries of Tehran University of Medical Sciences + Journal website
    empty
    فرآیند متداول در کتابخانه های دانشگاه ع پ تهران+ سایت مجله

Protocol summary

Study aim
To determine the efficacy of a special food (fried egg with grape molasses) on threatened abortion.
Design
A randomized controlled clinical trial
Settings and conduct
90 patients will include in the study. Participants of this study were selected from the women referring to the perinatology clinic of Vali-asr hospital and Persian medicine clinic of Tehran University of Medical Sciences, with mild or moderate vaginal hemorrhage up to 16 wk.
Participants/Inclusion and exclusion criteria
Pregnant women with threatened abortion issue with mild to moderate severity of vaginal bleeding, gestational age below 16 weeks, after confirming the ultrasound and the absence of exclusion criteria (mother systemic illness, history of recurrent miscarriage, Open cervix more than two centimeters, absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks GA, incomplete abortion, missed abortion or multiple gestation sacs in ultrasound) are enrolled.
Intervention groups
1- The control group received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between. 2- The intervention group received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week.
Main outcome variables
the event of pregnancy losses before 20 weeks in both study arms

General information

Reason for update
Some changes in the method and study date
Acronym
IRCT registration information
IRCT registration number: IRCT2016040627248N1
Registration date: 2016-07-09, 1395/04/19
Registration timing: prospective

Last update: 2022-02-17, 1400/11/28
Update count: 1
Registration date
2016-07-09, 1395/04/19
Registrant information
Name
Fatemeh Moradi
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6697 6527
Email address
fmoradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences, University School of Traditional Medicine
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2018-11-01, 1397/08/10
Trial completion date
2018-11-01, 1397/08/10
Scientific title
The Effects of a Special Food (Fried Eggs with Grape Molasses) on Threatened Miscarriage in Combination with Conventional Therapies: A Randomized Clinical Trial
Public title
Effect of a special food (fried egg with grape molasses) on threatened abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women presenting with mild to moderate vaginal bleeding (using 2 Pads or less per day) Up to 16 weeks of pregnancy Normal ultrasound (including a normal gestational sac at five wk of gestation, yolk sac at six wk, or fetal heart activity at seven wk of gestation or later) Closed cervix in vaginal examination Singleton pregnancy Having consent to participate in the study Tendency to consume this special food (in intervention group) No fried eggs with grape molasses in routine diet food
Exclusion criteria:
Mother systemic illness such as fever, diabetes, chronic hypertension History of recurrent miscarriage Heavy vaginal bleeding (>2 pads soaked) Loss of conception tissue Open cervix (>2 centimeters) in vaginal examination Cervical lesions such as polyps or cervicitis Abnormal findings on ultrasound (absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks gestational age, incomplete abortion, missed abortion) Multiple gestation sacs Molar pregnancy Fetal or uterine anomalies Allergy or intolerance to eggs, grape molasses or progesterone The patient withdrew from the study
Age
From 12 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks of six subjects carried out randomization and treatments’ allocation with using stata software version 13. The list of random allocation of patients will be available only to the epidemiologist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
None

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416663361
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.TUMS.VCR.REC.1395.121

Health conditions studied

1

Description of health condition studied
Threatened abortion
ICD-10 code
O20.0
ICD-10 code description
Haemorrhage specified as due to threatened abortion

Primary outcomes

1

Description
Determine the miscarriage rate (loss of an intrauterine pregnancy at ≤20 week’s gestation) in patients with threatened abortion
Timepoint
Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy
Method of measurement
Self-designed form

Secondary outcomes

1

Description
The average duration of vaginal bleeding
Timepoint
Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy
Method of measurement
Self-designed form

Intervention groups

1

Description
Control group: They received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between.
Category
Treatment - Drugs

2

Description
Intervention group: They received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week. "Khagineh Recipe: Beat together one egg and 25 g of grape molasses with salt until blended. Heat 5 g of pasteurized cow butter in a pan until it becomes hot. Pour the blended eggs onto the pan and brown on both sides."
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Perinatology clinic of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fatemeh Moradi
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blv,
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir

2

Recruitment center
Name of recruitment center
Traditional Iranian Medicine Ahmadiyeh clinic, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fatemeh Moradi
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 6697 6527
Email
dfmoradi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
Full name of responsible person
Dr Roja Rahimi
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Province
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Email
rojarahimi@gmail.com
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, School of Traditional medicine, Tehran University of Medical Scienc
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Moradi
Position
physician/ PhD of Traditional Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Province
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dfmoradi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Malieheh Tabarraie Arani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Province
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dr.mtabarrai@yahoo.com
Web page address
http://tim.tums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Moradi
Position
physiacian/ PhD of Iranian traditional medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Province
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dfmoradi@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
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
Title and more details about the data/document
Ph.D. thesis + journal article
When the data will become available and for how long
five years
To whom data/document is available
Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
Under which criteria data/document could be used
Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
From where data/document is obtainable
Referrals to the library of the Faculty of Traditional Medicine, Tehran University of Medical Sciences + Visitors to the journal website
What processes are involved for a request to access data/document
A common process in the libraries of Tehran University of Medical Sciences + Journal website
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