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Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome

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History
# Registration date Revision Id
2 2021-08-07, 1400/05/16 198659
1 2020-07-18, 1399/04/28 143641
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  • Protocol summary

    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
    تعیین اثر ‏ تر‏کیب میوه رازیانه و گل گاوزبان‏ ایرانی در مقایسه با پلاسبو بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    تعیین اثر ‏ تر‏کیب میوه رازیانه و گل گاوزبان‏ ایرانی بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    The personal form and PSST will be filled in by the students of Mashhad dormitories.qualified individuals by entry and non-entry criteria will complete the DRSP for two months for a definitive diagnosis of PMS, then 80 individuals will be selected and complete the Quality of Life and Temperament Questionnaire. before the intervention, the samples were statistically analyzed and randomly divided into two groups by software. The test group will receive Echium and fennel capsules, and the control receive placebo for 2 menstrual cycles. during which the DRSP is completed. capsules are distributed in the same form, package and number.
    The personal information form and PSST will be filled out by women referring to the traditional medicine clinic of Imam Reza Hospital in Mashhad for initial diagnosis. After reviewing the inclusion and non-inclusion criteria, eligible individuals will complete the DRSP for two months. After final confirmation, 80 samples will be randomly selected and complete a quality of life and temperament questionnaire. The permutation block method will be used to assign individuals to study groups. Sequence generation will be by random allocation software. The test group will receive Echium and fennel capsules and the control group will receive placebo. The study time is 2 cycles and during it the DRSP is completed.
    فرم مشخصات فردی وPSST توسط دانشجویان ساکن خوابگاه های مشهد جهت تشخيص اولیه پرمی شود. پس از بررسی معیارهای ورود و عدم ورود، افراد واجد شرایط به مدت دو ماه متوالي فرم DRSP را جهت تشخيص قطعی سندرم پيش از قاعدگي تكميل خواهند کرد، سپس 80 نفر انتخاب شده و پرسشنامه کیفیت زندگی و پرسشنامه تعیین مزاج را کامل می‏کنند. نمونه ‏ها‏ پیش از مداخله، مورد آنالیز آماری قرار گرفته، تصادفی با نرم افزار به دو گروه تقسيم می‏شوند. گروه‏ آزمون کپسول گاوزبان و رازیانه و گروه کنترل پلاسبو را دریافت خواهند کرد. زمان مطالعه 2 سیکل قاعدگی می‏باشدو در طول آن پرسشنامه DRSP تکمیل می‌شود. کپسول‏ها‏ی پلاسبو و گیاهی در شکل و بسته بندی و تعداد یکسان توزیع می‏شود.
    فرم مشخصات فردی وPSST توسط زنان مراجعه کننده به درمانگاه طب سنتی بیمارستان امام رضا(ع) مشهد جهت تشخيص اولیه پرمی شود. پس از بررسی معیارهای ورود و عدم ورود، افراد واجد شرایط به مدت دو ماه متوالي فرم DRSP را تكميل خواهند کرد، پس از تأييد قطعي، 80 نمونه به تصادف انتخاب شده و پرسشنامه کیفیت زندگی و تعیین مزاج را کامل می‏کنند. برای تخصیص افراد به گروه های مطالعه، از روش بلوک های جایگشتی استفاده خواهد شد. تولید توالی توسط نرم افزار random allocation خواهد بود. گروه‏ آزمون کپسول گاوزبان و رازیانه و گروه کنترل پلاسبو را دریافت خواهند کرد. زمان مطالعه 2 سیکل قاعدگی می‏باشدو در طول آن پرسشنامه DRSP تکمیل می‌شود.
    Inclusion: Age 18 to 35 years Single, Regular menstruation for 6 months Bleeding 3 to 9 and intervals 24 to 35 days Complete the conscious consent form minimum score of 19 from PSST non-Inclusion: History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension Death of a loved one in the last six months use of anti-anxiety and anti-depressant, estrogen and progesterone drugs in the last three months Taking herbal, vitamin and mineral supplements over the past month allergy to Echium and fennel
    Inclusion: Age 18 to 35 years Regular menstruation for 6 months Bleeding 3 to 9 and intervals 24 to 35 days Complete the conscious consent form minimum score of 19 from PSST non-Inclusion: History of mental illness, surgery, estrogen-related cancers, thyroid, liver, kidney disease, diabetes, hypertension Death of a loved one in the last six months use of anti-anxiety and anti-depressant, estrogen and progesterone drugs in the last three months Taking herbal, vitamin and mineral supplements over the past month allergy to Echium and fennel Pregnancy, lactation
    شرایط ورود: 18 تا 35 سال، مجرد منظم بودن منس در 6 ماه گذشته، بازه خونریزی 3 تا 9 روز و فاصله دو خونریزی 24 تا 35 روز، پر کردن فرم رضایت آگاهانه، حداقل نمره 19 از پرسشنامه PSST شرایط عدم ورود سابقه بیماری‏ها‏ی روانی، جراحی، سرطان‏ها‏ی وابسته به استروژن، بیماری‏ها‏ی تیروئید، کبدی و کلیوی و دیابت،‏ ها‏یپرتنشن، مرگ یکی از عزیزان در شش ماه گذشته، مصرف داروهای ضد اضطراب و افسردگی و داروهای حاوی استروژن و پروژسترون در سه ماه گذشته، مصرف داروهای گیاهی و مکملهای ویتامین و مواد معدنی در یک ماه گذشته، سابقه حساسیت به گل گاوزبان و رازیانه
    شرایط ورود: 18 تا 35 سال، منظم بودن منس در 6 ماه گذشته، بازه خونریزی 3 تا 9 روز و فاصله دو خونریزی 24 تا 35 روز، پر کردن فرم رضایت آگاهانه، حداقل نمره 19 از پرسشنامه PSST شرایط عدم ورود سابقه بیماری‏ها‏ی روانی، جراحی، سرطان‏ها‏ی وابسته به استروژن، بیماری‏ها‏ی تیروئید، کبدی و کلیوی و دیابت،‏ ها‏یپرتنشن، مرگ یکی از عزیزان در شش ماه گذشته، مصرف داروهای ضد اضطراب و افسردگی و داروهای حاوی استروژن و پروژسترون در سه ماه گذشته، مصرف داروهای گیاهی و مکملهای ویتامین و مواد معدنی در یک ماه گذشته، سابقه حساسیت به گل گاوزبان و رازیانه بارداری و زایمان
    Intervention: capsules (with a dose of 2 grams of Echium and 1 gram of fennel per day),in the second two weeks, In two consecutive cycles. placebo: capsule containing starch
    Intervention: capsules (with a dose of 2 grams of Echium and 1 gram of fennel per day),in the second two weeks, In two cycles. placebo: starch capsule

  • General information

    empty
    The closure of the dormitories due to the prevalence of COVID-19 caused a change in the sampling location, followed by a change in the entry criteria (being single) and the non-entry criteria (pregnancy and lactation). Due to the termination of the previous statistics consultant's cooperation with the university and the change of the consultant, the change of randomization method and statistical software was done according to his opinion. For ease of swallowing by the patient, the volume of capsules was reduced and the dose was increased.
    empty
    تعطیلی خوابگاه ها به علت شیوع COVID-19 باعث تغییر در محل نمونه گیری و به دنبال آن تغییر در کرایتریای ورود(مجرد بودن) و عدم ورود(بارداری و شیردهی) شد. به علت خاتمه همکاری مشاور آمار قبلی با دانشگاه و تغییر مشاور، تغییر نحوه تصادفی سازی و نرم افزار آماری بنا به نظر ایشان انجام شد. جهت راحتی بلع توسط بیمار، حجم کپسولها کاهش و وعده های مصرف افزایش یافت.
    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
    بررسی اثر تر‏کیب ‏میوۀ رازیانه و گل گاوزبان ایرانی ‏در مقایسه با پلاسبو بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    بررسی اثر تر‏کیب ‏میوۀ رازیانه و گل گاوزبان ایرانی ‏بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
    Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
    بررسی اثر تر‏کیب ‏میوۀ رازیانه و گل گاوزبان ایرانی ‏در مقایسه با پلاسبو بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    بررسی اثر تر‏کیب ‏میوۀ رازیانه و گل گاوزبان ایرانی بر شدت علایم جسمانی و روانشناختی سندرم پیش از قاعدگی
    Age 18 to 35 years
    Single,
    Regular menstruation for the past 6 months,
    Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days,
    Complete the conscious consent form
    Get a minimum score of 19 from the PSST questionnaire
    Age 18 to 35 years
    Regular menstruation for the past 6 months,
    Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days,
    Complete the conscious consent form
    Get a minimum score of 19 from the PSST questionnaire
    سن 18 تا 35 سال،
    مجرد بودن،
    منظم بودن منس در 6 ماه گذشته،
    بازه زمانی خونریزی 3 تا 9 روز و فاصله دو خونریزی 24 تا 35 روز،
    پر کردن فرم زضایت آگاهانه،
    دریافت حداقل نمره 19 از پرسشنامه PSST
    سن 18 تا 35 سال،
    منظم بودن منس در 6 ماه گذشته،
    بازه زمانی خونریزی 3 تا 9 روز و فاصله دو خونریزی 24 تا 35 روز،
    پر کردن فرم رضایت آگاهانه،
    دریافت حداقل نمره 19 از پرسشنامه PSST
    History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
    Death of a loved one in the last six months
    The use of anti-anxiety and anti-depressant drugs in the last three months,
    The use of estrogen and progesterone medications in the last three months,
    Taking herbal medicines and vitamin and mineral supplements over the past month,
    History of allergy to Echium and fennel
    History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
    Death of a loved one in the last six months
    The use of anti-anxiety and anti-depressant drugs in the last three months,
    The use of estrogen and progesterone medications in the last three months,
    Taking herbal medicines and vitamin and mineral supplements over the past month,
    History of allergy to Echium and fennel
    Pregnancy and lactation
    سابقه بیماری‏ها‏ی روانی، جراحی، سرطان‏ها‏ی وابسته به استروژن، بیماری‏ها‏ی تیروئید، کبدی و کلیوی و دیابت،‏ ها‏یپرتنشن،
    مرگ یکی از عزیزان در شش ماه گذشته،
    مصرف داروهای ضد اضطراب و افسردگی در سه ماه گذشته،
    استفاده از داروهای حاوی استروژن و پروژسترون در سه ماه گذشته،
    مصرف داروهای گیاهی و مکملهای ویتامین و مواد معدنی در یک ماه گذشته،
    سابقه حساسیت به گل گاوزبان و رازیانه
    سابقه بیماری‏ها‏ی روانی، جراحی، سرطان‏ها‏ی وابسته به استروژن، بیماری‏ها‏ی تیروئید، کبدی و کلیوی و دیابت،‏ ها‏یپرتنشن،
    مرگ یکی از عزیزان در شش ماه گذشته،
    مصرف داروهای ضد اضطراب و افسردگی در سه ماه گذشته،
    استفاده از داروهای حاوی استروژن و پروژسترون در سه ماه گذشته،
    مصرف داروهای گیاهی و مکملهای ویتامین و مواد معدنی در یک ماه گذشته،
    سابقه حساسیت به گل گاوزبان و رازیانه
    بارداری و شیردهی
    Simple randomization Unit: Individual It is not stratified Tools: PASS statistical software Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors.
    Permuted block randomization Unit: Individual It is not stratified Tools: random allocation statistical software Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors.
    تصادفی سازی ساده واحد: فرد لایه ای نیست ابزار: نرم افزار آماری PASS در رابطه با پنهان سازی: براساس توالی تخصیص تصادفی ایجاد شده یک فرد خارج از طرح پاکت های مهر و موم شده ای را براین اساس تهیه خواهد کرد و در اختیار مجریان قرار خواهد داد.
    تصادفی سازی به روش بلوکهای جایگشتی واحد: فرد لایه ای نیست ابزار: نرم افزار آماری random allocation در رابطه با پنهان سازی: براساس توالی تخصیص تصادفی ایجاد شده یک فرد خارج از طرح پاکت های مهر و موم شده ای را براین اساس تهیه خواهد کرد و در اختیار مجریان قرار خواهد داد.

  • Intervention groups

    #1
    Intervention group: The test group received oral capsules containing Echium and fennel at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, fasting in the morning and at night with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles.
    Intervention group: The test group received oral capsules containing Echium and fennel at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, three times a day with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles.
    گروه ‏آزمون کپسول خوراکی حاوی ‏تر‏کیب گاوزبان و رازیانه با دوز 2 گرم گل گاوزبان و 1 گرم میوه رازیانه (‏آسیاب و گرانول شده) در روز، صبح ناشتا و شب با یک لیوان آب ولرم‏، در دو هفته دوم سیکل، در ‏دو سیکل متوالی دریافت می‏کنند.
    گروه ‏آزمون کپسول خوراکی حاوی ‏تر‏کیب گاوزبان و رازیانه با دوز 2 گرم گل گاوزبان و 1 گرم میوه رازیانه (‏آسیاب و گرانول شده) در روز، سه بار در روز با یک لیوان آب ولرم‏، در دو هفته دوم سیکل، در ‏دو سیکل متوالی دریافت می‏کنند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Mashhad Medical Sciences Dormitory
    Name of recruitment center - Persian: خوابگاه علوم پزشکی مشهد
    Full name of responsible person - English: Simin Sadat Motevalli Haghi
    Full name of responsible person - Persian: سیمین سادات متولی حقی
    Street address - English: Campus of Medical Sciences Dormitories, Bahonar St., Vakilabad Blvd.
    Street address - Persian: بلوار وکیل آباد، خیابان باهنر، پردیس خوابگاه های علوم پزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177899191
    Phone: +98 51 3891 0394
    Fax:
    Email: motevalihs961@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Traditional medicine clinic of Imam Reza Hospital
    Name of recruitment center - Persian: درمانگاه طب سنتی بیمارستان امام رضا
    Full name of responsible person - English: Simin Sadat Motevalli Haghi
    Full name of responsible person - Persian: سیمین سادات متولی حقی
    Street address - English: Margin of Imam Reza (AS) Square, Ibn Sina St.
    Street address - Persian: مشهد - خیابان ابن سینا - حاشیه میدان امام رضا (ع)
    City - English: mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3802 2000
    Fax:
    Email: motevalihs961@mums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Ferdowsi University Dormitory Campus
    Name of recruitment center - Persian: پردیس خوابگاه دانشگاه فردوسی
    Full name of responsible person - English: Simin Sadat Motevalli Haghi
    Full name of responsible person - Persian: سیمین سادات متولی حقی
    Street address - English: Ferdowsi University Dormitory Campus
    Street address - Persian: پردیس خوابگاه دانشگاه فردوسی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177899191
    Phone: +98 51 3891 0394
    Fax:
    Email: motevalihs961@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر محسن تفقدی
    Full name of responsible person - Persian: Dr. Mohsen Tafaghadi
    Street address - English: University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
    Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9138813944
    Phone: +98 51 3841 1538
    Fax:
    Email: vcresraech@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohsen Tafaghadi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
    Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9138813944
    Phone: +98 51 3841 1538
    Fax:
    Email: vcresraech@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
Design
Phase 3 randomized triple-blind clinical trial of three witnessed blind groups, including an intervention group and a placebo group
Settings and conduct
The personal information form and PSST will be filled out by women referring to the traditional medicine clinic of Imam Reza Hospital in Mashhad for initial diagnosis. After reviewing the inclusion and non-inclusion criteria, eligible individuals will complete the DRSP for two months. After final confirmation, 80 samples will be randomly selected and complete a quality of life and temperament questionnaire. The permutation block method will be used to assign individuals to study groups. Sequence generation will be by random allocation software. The test group will receive Echium and fennel capsules and the control group will receive placebo. The study time is 2 cycles and during it the DRSP is completed.
Participants/Inclusion and exclusion criteria
Inclusion: Age 18 to 35 years Regular menstruation for 6 months Bleeding 3 to 9 and intervals 24 to 35 days Complete the conscious consent form minimum score of 19 from PSST non-Inclusion: History of mental illness, surgery, estrogen-related cancers, thyroid, liver, kidney disease, diabetes, hypertension Death of a loved one in the last six months use of anti-anxiety and anti-depressant, estrogen and progesterone drugs in the last three months Taking herbal, vitamin and mineral supplements over the past month allergy to Echium and fennel Pregnancy, lactation
Intervention groups
Intervention: capsules (with a dose of 2 grams of Echium and 1 gram of fennel per day),in the second two weeks, In two cycles. placebo: starch capsule
Main outcome variables
The rate of changes in the severity of symptoms of PMS

General information

Reason for update
The closure of the dormitories due to the prevalence of COVID-19 caused a change in the sampling location, followed by a change in the entry criteria (being single) and the non-entry criteria (pregnancy and lactation). Due to the termination of the previous statistics consultant's cooperation with the university and the change of the consultant, the change of randomization method and statistical software was done according to his opinion. For ease of swallowing by the patient, the volume of capsules was reduced and the dose was increased.
Acronym
IRCT registration information
IRCT registration number: IRCT20200530047600N1
Registration date: 2020-07-18, 1399/04/28
Registration timing: prospective

Last update: 2021-09-21, 1400/06/30
Update count: 1
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Simin sadat Motevalli Haghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 0394
Email address
motevalihs961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
Public title
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years Regular menstruation for the past 6 months, Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days, Complete the conscious consent form Get a minimum score of 19 from the PSST questionnaire
Exclusion criteria:
History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension Death of a loved one in the last six months The use of anti-anxiety and anti-depressant drugs in the last three months, The use of estrogen and progesterone medications in the last three months, Taking herbal medicines and vitamin and mineral supplements over the past month, History of allergy to Echium and fennel Pregnancy and lactation
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization Unit: Individual It is not stratified Tools: random allocation statistical software Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The same capsules, with the same number, are placed in similar enveloped envelopes (from 1 to 80) based on a random assignment list by a person outside the research design.The study subjects receive the capsules monthly and in envelopes with the code. Participants, researchers, data evaluators, and data analysts are unaware of how the code is assigned.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of Mashhad University of Medical Sciences
Street address
Ethics Committee in Research, Central University Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUMS.REC.1399.276

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
The rate of change in the severity of symptoms of premenstrual syndrome
Timepoint
Before the intervention, the first menstrual cycle after the intervention, the second menstrual cycle after the intervention
Method of measurement
Daily Record of Severity of Problems (DRSP)

Secondary outcomes

1

Description
The relationship between general temperament and the severity of symptoms
Timepoint
At the beginning of the study
Method of measurement
Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ)

2

Description
Changes in the quality of life in the intervention and control groups
Timepoint
Before and after the intervention
Method of measurement
Short-Form Health Survey questionnaire(SF-36)

3

Description
possible side effects
Timepoint
During the intervention
Method of measurement
Patient report

4

Description
The relationship between general temperament and the type of symptoms
Timepoint
At the beginning of the study
Method of measurement
Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ)

Intervention groups

1

Description
Intervention group: The test group received oral capsules containing Echium and fennel at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, three times a day with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive a placebo capsule containing starch with the conditions of the intervention group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Traditional medicine clinic of Imam Reza Hospital
Full name of responsible person
Simin Sadat Motevalli Haghi
Street address
Margin of Imam Reza (AS) Square, Ibn Sina St.
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
motevalihs961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghadi
Street address
University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Simin Sadat Motevalli Haghi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Maliha Motusalian
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
MotavasselianM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Simin Sadat Motevalli Haghi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.ac.ir

Sharing plan

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