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Comparison of the effect of Urtica dioica, acupuncture and their combined therapy on hot flashes during menopause

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History
# Registration date Revision Id
2 2018-10-20, 1397/07/28 64471
1 2017-08-13, 1396/05/22 7705
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  • Protocol summary

    The aim of study: to compare the effect of urticaria dioica and acupuncture on hot flash and other monopausal symptoms. Design: Randomized, double blind, placebo controlled, parallel, phase 3 trial. Methods: 45 to 60 year old menopausal patients who met the inclusion criteria will be randomly assigned to one of four study groups and treated for 7 weeks. The number and severity of hot flushes per day according to the patient's daily report, the severity of menopausal symptoms according to the Menopausal Rating Scale questionnaire and level FSH, estradiol, LH will be compared before and after the study in all four groups. A. study population: post-menopausal women aged 45 to 60 with hot flashes. The main inclusion criteria :1-post-menopausal women aged 45-60 years who sign the written consent. The main outcomes of the study: 1- History of hysterectomy or oophorectomy 2- Taking anticancer therapies 3- suffering from estrogen-related cancers over the past 5 years. 4. History of mental disorder 5- Hyperthyroidism or hypothyroidism 6. Taking any medication for hot flashes in the past 8 weeks 7- Endometrial thickness over 12 mm in uterine ultrasonography 8-Vaginal bleeding with unknown origin in the last 6 months o Sample size 68 B) Intervention or intervention nettle, acupuncture, combination of both. C-intervention time 7 weeks. D-Primary outcome. Or outcomes • Number and severity of hot flushes per day • Severity of other symptoms of menopause • FSH, estradiol, LH
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    هدف مطالعه: بررسی اثر گزنه و طب سوزنی بر علائم بالینی گرگرفتگی طراحي انجام مطالعه: تصادفي، دو سويه كور، كنترل با دارو نما، موازی، مرحله سه كارآزمايي روش انجام مطالعه شامل بيماران منوپوز 45 تا 60 ساله مراجعه کننده در صورت تطابق با معیارهای ورود و خروج بصورت تصادفی در یکی از 4 گروه مطالعه قرار گرفته و به مدت 7 هفته تحت درمان قرار می گیرند. تعداد و شدت حملات گرگرفتگی در روز بر اساس گزارش روزانه بیمار، شدت علایم یائسگی بر اساس پرسشنامه MRS و FSH، استرادیول، LH قبل و بعد از مطالعه در هر چهار گروه اندازه گیری و مقایسه می شوند. الف- جمعيت مورد مطالعه خانم های پست منوپوزال 45 تا 60 ساله مبتلا به گرگرفتگی معيارهاي اصلي ورود به مطالعه: 1- خانم های پست منوپوزال 45 تا 60 ساله با رضایت شرکت در طرح معيارهاي اصلي خروج از مطالعه : 1- سابقه هیسترکتومی یا اووفورکتومی 2- دریافت درمانهای ضد کانسر 3- مبتلا به کانسرهای استروژنی در پنج سال گذشته 4- سابقه اختلال رواني 5- هیپرتیروییدیسم یا هیپوتیروییدیسم 6- دریافت هرگونه درمان دارویی جهت گرگرفتگی در 8 هفته گذشته 7- ضخامت آندومتر بیش از 12 میلیمتر در سونوگرافی رحم 8- خونریژی واژینال با منشا نا مشخص در طی شش ماه گذشته حجم نمونه : 68 ب‌- مداخله يا مداخلات مورد مطالعه گزنه، طب سوزنی، تلفیقی از هر دو ج‌- زمان مداخله 7 هفته د‌- پيامد اوليه يا پيامدهاي مورد مطالعه • تعداد و شدت حملات گرگرفتگی در روز • شدت سایر علایم یائسگی • FSH، استرادیول، LH
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    Comparison of effect of nettle, acupuncture and combined treatment with placebo in menopausal hot flashes
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    مقایسه اثر گزنه، طب سوزنی و درمان تلفیقی با پلاسبو در گرگرفتگی یائسگی
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    Randomized, double blinded, placebo controlled, community based pragmatic clinical trial with a parallel group
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    کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروههای موازی، دوسویه کور، تصادفی شده
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    Chinese and Complementary Medicine clinic & Gynecology clinic, Imam Reza Hospital
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    درمانگاه طب چینی و مکمل و درمانگاه زنان بیمارستان امام رضا
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    Inclusion criteria: Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes; Age 45-60 years old; Approval for treatment of hot flashes; Consent to participate in the study. Exclusion Criteria: History of hysterectomy or oophorectomy; Anticancer therapies due to malignancy; History of estrogen-dependent cancers over the past five years; History of allergy to urticaria; History of known psychiatric disorders; Hyperthyroidism or hypothyroidism; ;Cardiovascular disease (coronary artery disease, cerebrovascular disease and thromboembolic disorders); Uncontrolled Hypertension; Uncontrolled diabetes; Kidney or liver failure; Use of anticoagulants; Taking any medication for hot flashes such as HRT and SSRI in the past eight weeks; Endometrial thickness over 12 mm in uterine ultrasonography; Vaginal bleeding with unknown origin in the past 6 months
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    شرایط ورود: خانم های پست منوپوزال ( تعریف پست منوپوز: آمنوره برای 12 ماه یا بیشتر) که از گرگرفتگی رنج می برند؛ سن60-45 ساله؛ موافقت جهت درمان گرگرفتگی؛ رضایت به شرکت در مطالعه شرایط عدم ورود: سابقه هیسترکتومی یا اووفورکتومی درمانهای ضد کانسر بعلت مالیگنانسی؛ تاریخچه ای از کانسرهای وابسته به استروژن در پنج سال گذشته؛ سابقه آلرژی به گزنه؛ سابقه اختلال رواني شناخته شده؛ هیپرتیروییدیسم یا هیپوتیروییدیسم؛ بیماری قلبی – عروقی( بیماری عروق کرونری، بیماری عروق مغزی و اختلالات ترومبوآمبولیک)؛ فشار خون کنترل نشده؛ دیابت کنترل نشده؛ نارسایی کلیه یا کبد؛ مصرف داروهای ضدانعقاد؛ دریافت هرگونه درمانهای دارویی مثل HRT و SSRI جهت گرگرفتگی در طی 8 هفته گذشته؛ ضخامت آندومتر بیش از 12 میلیمتر در سونوگرافی رحم؛ خونریزی واژینال با منشا نامشخص در طی شش ماه گذشته
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    1-Intervention group 1: Nettle in the form of an orthodine tablet with a dose of 150 mg three times a day and an acupuncture twice a week for 7 weeks. 2- Intervention group 2: Placebo of Nettle three times a day and acupuncture twice a week for 7 weeks. 3- Intervention 3: Nettle in the form of an orthodine pill with a dose of 150 mg every three times a day and an acupuncture twice a week for 7 weeks. 4-Placebo group: Placebo of Nettle three times a day and tampon acupuncture twice a week for 7 weeks
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    1-گروه مداخله1: گزنه به شکل قرص اورتیدین با دوز 150میلی گرم روزی سه بار و آکوپانکچر دو بار در هفته بمدت 7 هفته 2- گروه مداخله 2: پلاسبوی گزنه روزی سه بار و آکوپانکچر دو بار در هفته بمدت 7 هفته 3- گروه مداخله 3: گزنه به شکل قرص اورتیدین با دوز 150میلی گرم روزی سه بار و شم آکوپانکچر دو بار در هفته بمدت 7 هفته 4- گروه پلاسبو: پلاسبوی گزنه روزی سه بار و شم آکوپانکچر دو بار در هفته بمدت 7 هفته
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    Number and severity of hot flashes; measurement of LH and FSH and estradiol MRS questionnaire
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    تعداد و شدت گرگرفتگی؛ سطح LH و FSH و استرادیول؛ پرسشنامهMRS

  • General information

    Nettle and acupuncture in hot flashes
    1
    1
    1
    1
    Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes.
    Age 45-60 years old
    Approval for treatment of hot flashes and consent to participate in the plan.
    خانم های پست منوپوزال ( تعریف پست منوپوز: آمنوره برای 12 ماه یا بیشتر) که از گرگرفتگی رنج می برند.
    سن60-45 ساله
    موافقت جهت درمان برای گرگرفتگی و رضایت به شرکت در طرح
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    Sealed envelopes
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    پاکت مهروموم شده
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    Participants, researcher, questioner, and data analyzer will be blind in this study.
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    شرکت کنندگان، محقق ، پرسشگر و فرد آنالیز کننده داده ها در این مطالعه کور خواهند بود.

  • Primary outcomes

    #1
    Before the study and at week 7
    Before the study and at week 8
    قبل از مداخله و در هفته 7
    قبل از مداخله و در هفته 8
    #2
    Before the intervention, week 4 and 7
    Before the intervention, week 5 and 8
    قبل از شروع مداخله، در هفته4و7
    قبل از شروع مداخله، در هفته 5و 8
    Menopausal Rating Scale questionnaire
    Menopausal Quality of Life Questionnaire
    پرسشنامه MRS
    پرسشنامه menqol
    #3
    One week before the study and at weeks 4 and 7
    One week before the study and at weeks 5 and 8
    یک هفته قبل از شروع مطالعه و در هفته 4 و 7
    یک هفته قبل از شروع مطالعه و در هفته 5و 8

  • Recruitment centers

    #1
    Name of recruitment center - English: Acupuncture clinic of 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 of 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: 91357345
    Phone: +98 51 3884 8932
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Gynecology Clinic of Imam Reza Hospital
    Name of recruitment center - Persian: درمانگاه زنان بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Salmeh Dadgar
    Full name of responsible person - Persian: دکتر سلمه دادگر
    Street address - English:
    Street address - Persian:
    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: Gynecology Clinic of Imam Reza Hospital
    Name of recruitment center - Persian: درمانگاه زنان بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Salmeh Dadgar
    Full name of responsible person - Persian: دکتر سلمه دادگر
    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: dadgars@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: Deputy of research office, MUMS central office, Daneshgah street
    Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه علوم پزشکی مشهد، دفتر معاونت پژوهشی
    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: Deputy of research office, MUMS central office, Daneshgah street
    Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه علوم پزشکی مشهد، دفتر معاونت پژوهشی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91357345
    Phone: +98 51 3459 1357
    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: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Position - English: Clinical Ph.D./Assistant professor
    Position - Persian: دکترای تخصصی بالینی/ استادیار دانشگاه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, Azadi Square
    Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده طب سنتی و مکمل، گروه طب چینی و مکمل مشهد
    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: +98 915313719400
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr Hoda Azizi
    Full name of responsible person - Persian: دکتر هدا عزیزی
    Position - English: Clinical Ph.D./Assistant professor
    Position - Persian: دکترای تخصصی بالینی/ استادیار دانشگاه
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: Acupuncturist
    Area of specialty/work title - Persian: متخصص طب سوزنی
    Street address - English: Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, Azadi Square
    Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده طب سنتی و مکمل، گروه طب چینی و مکمل مشهد
    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 915313719400
    Fax:
    Email: azizih@mums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Roshanak Salari
    Full name of responsible person - Persian: دکتر روشنک سالاری
    Position - English: Ph.D. in Pharmacy / Assistant Professor
    Position - Persian: دکترای تخصصی داروسازی/ استادیار دانشگاه
    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 and complementary medicine, University campus, Azadi Square
    Street address - Persian: میدان آزادی،پردیس دانشگاه، دانشکده طب سنتی و مکمل
    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: +98 915 111 0785
    Fax:
    Email: salarir@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Roshanak Salari
    Full name of responsible person - Persian: دکتر روشنک سالاری
    Position - English: Ph.D. in Pharmacy / Assistant Professor
    Position - Persian: دکترای تخصصی داروسازی/ استادیار دانشگاه
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: داروسازی سنتی
    Area of specialty/work title - Persian: Pharmacy Tradition
    Street address - English: School of traditional and complementary medicine, University campus, Azadi Square
    Street address - Persian: میدان آزادی،پردیس دانشگاه، دانشکده طب سنتی و مکمل
    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: +98 915 111 0785
    Fax:
    Email: salarir@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 Raheleh kargozar
    Full name of responsible person - Persian: دکتر راحله کارگزار
    Position - English: Ph.D. student of Traditional Medicine
    Position - Persian: دانشجوی دکترای تخصصی طب سنتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: +98 912 582 7899
    Fax:
    Email: kargozarr931@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 Raheleh kargozar
    Full name of responsible person - Persian: دکتر راحله کارگزار
    Position - English: Ph.D. student of Traditional Medicine
    Position - Persian: دانشجوی دکترای تخصصی طب سنتی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English: Traditional Iranian Medicine
    Area of specialty/work title - Persian: طب سنتی ایران
    Street address - English: School of Iranian and Complementary Medicine, University campus, Azadi Square
    Street address - Persian: میدان آزادی،پردیس دانشگاه، دانشکده طب سنتی و مکمل
    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: +98 912 582 7899
    Fax:
    Email: kargozarr931@mums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
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    No more information.
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    اطلاعات بیشتری وجود ندارد.

Protocol summary

Study aim
Comparison of effect of nettle, acupuncture and combined treatment with placebo in menopausal hot flashes
Design
Randomized, double blinded, placebo controlled, community based pragmatic clinical trial with a parallel group
Settings and conduct
Chinese and Complementary Medicine clinic & Gynecology clinic, Imam Reza Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes; Age 45-60 years old; Approval for treatment of hot flashes; Consent to participate in the study. Exclusion Criteria: History of hysterectomy or oophorectomy; Anticancer therapies due to malignancy; History of estrogen-dependent cancers over the past five years; History of allergy to urticaria; History of known psychiatric disorders; Hyperthyroidism or hypothyroidism; ;Cardiovascular disease (coronary artery disease, cerebrovascular disease and thromboembolic disorders); Uncontrolled Hypertension; Uncontrolled diabetes; Kidney or liver failure; Use of anticoagulants; Taking any medication for hot flashes such as HRT and SSRI in the past eight weeks; Endometrial thickness over 12 mm in uterine ultrasonography; Vaginal bleeding with unknown origin in the past 6 months
Intervention groups
1-Intervention group 1: Nettle in the form of an orthodine tablet with a dose of 150 mg three times a day and an acupuncture twice a week for 7 weeks. 2- Intervention group 2: Placebo of Nettle three times a day and acupuncture twice a week for 7 weeks. 3- Intervention 3: Nettle in the form of an orthodine pill with a dose of 150 mg every three times a day and an acupuncture twice a week for 7 weeks. 4-Placebo group: Placebo of Nettle three times a day and tampon acupuncture twice a week for 7 weeks
Main outcome variables
Number and severity of hot flashes; measurement of LH and FSH and estradiol MRS questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201707017265N10
Registration date: 2017-08-13, 1396/05/22
Registration timing: registered_while_recruiting

Last update: 2018-10-25, 1397/08/03
Update count: 1
Registration date
2017-08-13, 1396/05/22
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
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Urtica dioica, acupuncture and their combined therapy on hot flashes during menopause
Public title
Treatment of menopause by Nettle and acupuncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-menopausal women (defined as: amenorrhea for 12 months or more) who suffer from hot flashes. Age 45-60 years old Approval for treatment of hot flashes and consent to participate in the plan.
Exclusion criteria:
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researcher, questioner, and data analyzer will be blind in this study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of research, Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.MUMS.REC.1396.144

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Level of FSH, estradiol, LH
Timepoint
Before the study and at week 8
Method of measurement
blood test

2

Description
Severity of menopausal symptoms
Timepoint
Before the intervention, week 5 and 8
Method of measurement
Menopausal Quality of Life Questionnaire

3

Description
Number and severity of hot flashes per day
Timepoint
One week before the study and at weeks 5 and 8
Method of measurement
Patient Daily Report

Secondary outcomes

empty

Intervention groups

1

Description
Acupuncture, two sessions/week from week 1 to 4, and one session/week through weeks 5 to 7 + nettle in the form of Urtidin tablet 150 mg, 3 times/ day for 7 weeks.
Category
Treatment - Other

2

Description
Acupuncture, two sessions from week one to fourth and one session at week five through seventh + placebo nettle, once every three weeks for seven weeks.
Category
Other

3

Description
Acupuncture sham, two sessions from week one to fourth, and one session in the fifth to seventh week + nettle in the form of a 150 mg orthidine tablet every three times for seven weeks.
Category
Other

4

Description
Acupuncture sham, two sessions from week one to fourth and one session at week five to seven + placebo nettle three times a day for seven weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Acupuncture clinic of Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3884 8932
Email
azizih@mums.ac.ir

2

Recruitment center
Name of recruitment center
Gynecology Clinic of Imam Reza Hospital
Full name of responsible person
Dr. Salmeh Dadgar
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2035
Email
dadgars@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
Deputy of research office, MUMS central office, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3459 1357
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Clinical Ph.D./Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncturist
Street address
Department of Chinese and complementary medicine, School of traditional and complementary medicine, University Campus, 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 scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roshanak Salari
Position
Ph.D. in Pharmacy / Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
داروسازی سنتی
Street address
School of traditional and complementary medicine, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
salarir@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 Raheleh kargozar
Position
Ph.D. student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Iranian Medicine
Street address
School of Iranian and Complementary Medicine, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
kargozarr931@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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