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Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences

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History
# Registration date Revision Id
2 2022-05-14, 1401/02/24 228111
1 2018-04-24, 1397/02/04 43368
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  • Protocol summary

    Effect of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women
    Effect of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
    بررسی تاثیر کپسول رازیانه بر علائم یائسگی و هورمونهای جنسی در زنان یائسه
    بررسی تاثیر کپسول رازیانه و روغن گل مغربی بر علائم یائسگی و هورمونهای جنسی در زنان یائسه
    Clinical trial with control group, simple sampling and sample size 100, blind, randomized
    Clinical trial with control group, simple sampling and sample size150, blind, randomized
    کارآزمایی بالینی دارای گروه کنترل، نمونه گیری به روش آسان مبتنی بر هدف و حجم نمونه 100 نفر، دو سویه کور ، تصادفی شده
    کارآزمایی بالینی دارای گروه کنترل، نمونه گیری به روش آسان مبتنی بر هدف و حجم نمونه 150نفر، دو سویه کور ، تصادفی شده
    The research population of all postmenopausal women aged 45-60 years old who referred to the clinics of Shiraz University of Medical Sciences were selected and the sampling would be based on the objective based on the criteria of entry and then divided into two groups of intervention and control with a random number table. Took For people with entry criteria and willingness to participate in the research, the demographic questionnaire will be completed, the menopause measurement criteria will be completed and the research samples will be divided into two intervention and control groups of 50 people according to the random numbers table. The intervention group uses fennel capsules and control groups of placebo capsules. All capsules will be placed in the same packages with codes A and B. The contents of capsules A and B will be retained for samples and unidentified clinical caregivers. Therefore, the present study is two-blind
    The study population is all postmenopausal women aged 45-60 years referred to the clinics of Shiraz University of Medical Sciences and sampling will be done in an easy method based on purpose based on inclusion criteria and then divided into two intervention groups and a control group with a table of random numbers. it is going to happen. For people who have the criteria to enter the research and want to participate in the research, the questionnaire of demographic characteristics, the criterion of menopause will be completed and the research samples will be divided into two groups based on a random number table and a control group of 50 people. In this way, the intervention groups will take placebo capsules containing fennel and evening primrose oil and the control group will take placebo capsules. The contents of capsules A, B and C will be preserved for unknown samples and clinical caregivers, so the present study will be double-blind.
    جامعه پژوهش کلیه زنان یائسه 60-45 ساله مراجعه کننده به درمانگاههای دانشگاه علوم پزشکی شیرازمی باشند و نمونه گیری به روش آسان مبتنی بر هدف بر اساس معیار های ورود انجام خواهد شد و سپس تقسیم به دو گروه مداخله و کنترل با جدول اعداد تصادفی صورت خواهد گرفت. برای افرادي كه داراي معيارهاي ورود به پژوهش بوده و تمايل به شركت در پژوهش را دارند پرسشنامه مشخصات فردی، معیار سنجش یائسگی تکمیل خواهد شد و نمونه های پژوهش بر اساس جدول اعداد تصادفی به دو گروه مداخله و کنترل 50 نفره تقسیم خواهند شد. بدين صورت كه گروه مداخله از کپسول های حاوی رازیانه وگروه کنترل از کپسول های دارونما استفاده می نمایند. كليه ي كپسول ها در بسته هاي مشابه و با كد الف و ب قرار خواهند گرفت. محتواي كپسول هاي الف و ب براي نمونه ها و مراقب بالینی ناشناخته حفظ خواهد شد. لذا پژوهش حاضر دو سوكور خواهد بود.
    جامعه پژوهش کلیه زنان یائسه 60-45 ساله مراجعه کننده به درمانگاههای دانشگاه علوم پزشکی شیراز می باشند و نمونه گیری به روش آسان مبتنی بر هدف بر اساس معیار های ورود انجام خواهد شد و سپس تقسیم به دو گروه مداخله و یک گروه کنترل با جدول اعداد تصادفی صورت خواهد گرفت. برای افرادی كه دارای معيارهای ورود به پژوهش بوده و تمايل به شركت در پژوهش را دارند پرسشنامه مشخصات فردی، معیار سنجش یائسگی تکمیل خواهد شد و نمونه های پژوهش بر اساس جدول اعداد تصادفی به دو گروه مداخله و یک گروه کنترل 50 نفره تقسیم خواهند شد. بدين صورت كه گروههای مداخله از کپسول های حاوی رازیانه و روغن گل مغربی و گروه کنترل کپسول های پلاسبو خواهند گرفت. محتوای كپسول های الف و ب و ج برای نمونه ها و مراقب بالینی ناشناخته حفظ خواهد شد، لذا پژوهش حاضر دو سوكور خواهد بود.
    Entry requirements: 1-Failure to receive HRT 2- Not getting breast cancer treatment (hormone therapy) 3-Lack of surgery in ovarian tumors Non-arrival conditions: 1- Sudden increase or decrease of weight in the sample 2- Any reason that increases or decreases the level of estrogen in the body 3- For any reason, a person has to have hormone therapy 4- Any sign indicating that allergy to fennel has manifested itself 5- Examples that can cause menstrual disorder for any reason
    Entry requirements: 1-Failure to receive HRT 2- Not getting breast cancer treatment (hormone therapy) 3-Lack of surgery in ovarian tumors Non-arrival conditions: 1- Sudden increase or decrease of weight in the sample 2- Any reason that increases or decreases the level of estrogen in the body 3- For any reason, a person has to have hormone therapy 4- Any sign indicating that allergy to fennel and evening primrose oil has manifested itself 5- Examples that can cause menstrual disorder for any reason
    شرایط ورود:1- عدم دریافت HRT 2- عدم دریافت درمان سرطان پستان ( درمان هورمونی) 3- عدم جراحی در تومورهای تخمدان شرایط عدم ورود:1- افزایش یا کاهش ناگهانی وزن در نمونه 2- هر دلیلی که باعث افزایش و کاهش سطح استروژن بدن شود 3- به هر دلیلی فرد مجبور به هورمون درمانی باشد 4- هر علامتی دال بر اینکه حساسیت به رازیانه در فرد بروز کرده است 5- نمونه هایی که به هر دلیل اختلال قاعدگی پیدا کنند
    شرایط ورود:1- عدم دریافت HRT 2- عدم دریافت درمان سرطان پستان ( درمان هورمونی) 3- عدم جراحی در تومورهای تخمدان شرایط عدم ورود:1- افزایش یا کاهش ناگهانی وزن در نمونه 2- هر دلیلی که باعث افزایش و کاهش سطح استروژن بدن شود 3- به هر دلیلی فرد مجبور به هورمون درمانی باشد 4- هر علامتی دال بر اینکه حساسیت به رازیانه و روغن گل مغربی در فرد بروز کرده است 5- نمونه هایی که به هر دلیل اختلال قاعدگی پیدا کنند
    The intervention group uses fennel capsules and a control group of placebo capsules
    The intervention groups uses fennel capsules and evening primrose oil and a control group of placebo capsules
    گروه مداخله از کپسول های حاوی رازیانه وگروه کنترل از کپسول های دارونما استفاده می نمایند
    گروههای مداخله از کپسول های حاوی رازیانه و روغن گل مغربی و گروه کنترل از کپسول های دارونما استفاده می نمایند

  • General information

    100
    150
    2018-04-03, 1397/01/14
    2020-05-02, 1399/02/13
    2018-07-20, 1397/04/29
    2020-11-18, 1399/08/28
    empty
    At the time of the project, the conditions for using another herbal medicine, namely evening primrose oil, were available, so a trial was conducted in three groups.
    empty
    در زمان اجرای طرح شرایط استفاده از یک داروی گیاهی دیگر یعنی روغن گل مغربی فراهم بود به همین دلیل کارآزمایی در سه گروه انجام شد.
    Effect of Of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women
    Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
    بررسی تاثیر کپسول رازیانه بر علائم یائسگی و هورمونهای جنسی در زنان یائسه
    بررسی تاثیر کپسول رازیانه و روغن گل مغربی بر علائم یائسگی و هورمونهای جنسی در زنان یائسه
    Effect of Of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
    Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
    بررسی تاثیر کپسول رازیانه بر علائم یائسگی و هورمونهای جنسی در زنان یائسه مراجعه کننده به درمانگاههای دانشگاه علوم پزشکی شیراز
    بررسی تاثیر کپسول رازیانه و روغن گل مغربی بر علائم یائسگی و هورمونهای جنسی در زنان یائسه مراجعه کننده به درمانگاههای دانشگاه علوم پزشکی شیراز
    Sudden increase or decrease of weight in the sample
    Any reason that increases or decreases the level of estrogen in the body
    For any reason, a person has to have hormone therapy
    Any sign indicating that allergy to fennel has manifested itself
    Examples that can cause menstrual disorder for any reason
    Sudden increase or decrease of weight in the sample
    Any reason that increases or decreases the level of estrogen in the body
    For any reason, a person has to have hormone therapy
    Any sign indicating that allergy to fennel and evening primrose oil has manifested itself
    Examples that can cause menstrual disorder for any reason
    افزایش یا کاهش ناگهانی وزن در نمونه
    هر دلیلی که باعث افزایش و کاهش سطح استروژن بدن شود
    به هر دلیلی فرد مجبور به هورمون درمانی باشد
    هر علامتی دال بر اینکه حساسیت به رازیانه در فرد بروز کرده است
    نمونه هایی که به هر دلیل اختلال قاعدگی پیدا کنند
    افزایش یا کاهش ناگهانی وزن در نمونه
    هر دلیلی که باعث افزایش و کاهش سطح استروژن بدن شود
    به هر دلیلی فرد مجبور به هورمون درمانی باشد
    هر علامتی دال بر اینکه حساسیت به رازیانه و روغن گل مغربی در فرد بروز کرده است
    نمونه هایی که به هر دلیل اختلال قاعدگی پیدا کنند
    Sampling was done in a simple method based on purpose based on entry criteria and then divided into two groups: intervention and control using random numbers
    Sampling was performed by easy method based on purpose based on inclusion criteria and then divided into two groups of intervention and a control group using a table of random numbers.
    نمونه گیری به روش آسان مبتنی بر هدف بر اساس معیار های ورود انجام و سپس به دو گروه مداخله و کنترل با استفاده ازجدول اعداد تصادفی تقسیم شد
    نمونه گیری به روش آسان مبتنی بر هدف بر اساس معیار های ورود انجام و سپس به دو گروه مداخله و یک گروه کنترل با استفاده ازجدول اعداد تصادفی تقسیم شد.
    The intervention group uses fennel capsules and a control group of placebo capsules. All capsules will be placed in the same packages with codes A and B. The contents of capsules A and B will be retained for samples and unidentified clinical caregivers. Therefore, the present study will be two-blind
    The intervention groups use capsules containing fennel and evening primrose oil and the control group used placebo capsules. All capsules will be in similar packages with codes A, B and C. The contents of capsules A, B, and C will be preserved for unknown samples and clinical caregivers. Therefore, the present study will be two blinds.
    گروه مداخله از کپسول های حاوی رازیانه وگروه کنترل از کپسول های دارونما استفاده می نمایند. كليه ي كپسول ها در بسته هاي مشابه و با كد الف و ب قرار خواهند گرفت. محتواي كپسول هاي الف و ب براي نمونه ها و مراقب بالینی ناشناخته حفظ خواهد شد. لذا پژوهش حاضر دو سوكور خواهد بود
    گروههای مداخله از کپسول های حاوی رازیانه و روغن گل مغربی وگروه کنترل از کپسول های دارونما استفاده می نمایند. كليه ی كپسول ها در بسته های مشابه و با كد الف و ب و ج قرار خواهند گرفت. محتوای كپسول های الف و ب و ج برای نمونه ها و مراقب بالینی ناشناخته حفظ خواهد شد. لذا پژوهش حاضر دو سوكور خواهد بود.

  • Health conditions studied

    #1
    N95.1
    empty
    Menopausal and female climacteric states
    empty
    Menopause
    Menopausal and female climacteric states
    منوپوز
    یائسگی و علائم یائسگی در زنان

  • Secondary outcomes

    #1
    ابزار مختص ارزشیابی شدت علائم زنان یائسهMRS
    ابزار مختص ارزشیابی شدت علائم زنان یائسه MRS

  • Intervention groups

    #1
    Intervention group: Oral capsules of 100 mg Fennle for 2 months twice a day
    Intervention groups one: The first group of 30 mg capsules of fennel extract for two months and orally twice a day.
    گروه مداخله: کپسولهای 100 میلی گرمی عصاره رازیانه برای مدت سه ماه و به صورت خوراکی دو بار در روز
    گروههای مداخله یک : گروه اول کپسولهای 30 میلی گرمی عصاره رازیانه برای مدت دو ماه و به صورت خوراکی دو بار در روز
    #2
    Placebo
    Prevention
    Control group: Oral capsules of 100 mg placebo for 2 months twice a day
    Intervention group two: 1000 mg capsules of evening primrose oil for two months and orally twice a day.
    گروه کنترل: کپسولهای 100 میلی گرمی دارونما برای مدت دو ماه و به صورت خوراکی دو بار در روز
    گروه مداخله دو : کپسولهای 1000 میلی گرمی روغن گل مغربی برای مدت دو ماه و به صورت خوراکی دو بار در روز
    #3
    empty
    Placebo
    empty
    Control group: Oral capsules of 100 mg placebo for 2 months twice a day.
    empty
    گروه کنترل: کپسولهای 100 میلی گرمی دارونما برای مدت دو ماه و به صورت خوراکی دو بار در روز

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr janghorban Roxana
    Full name of responsible person - Persian: دکتر رکسانا جان قربان
    Street address - English: Shiraz University of Medical Sciences, Setad Blvd., Shiraz
    Street address - Persian: شیراز، خیابان ستاد، دانشگاه علوم پزشکی شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 71944
    Phone: +98 71 3230 5410
    Fax: +98 71 3647 4252
    Email: researchnu@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Janghorban Roxana
    Full name of responsible person - Persian: دکتر رکسانا جان قربان
    Street address - English: Shiraz University of Medical Sciences, Setad Blvd., Shiraz
    Street address - Persian: شیراز، خیابان ستاد، دانشگاه علوم پزشکی شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 71944
    Phone: +98 71 3230 5410
    Fax: +98 71 3647 4252
    Email: researchnu@sums.ac.ir
    Web page address:

Protocol summary

Study aim
Effect of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
Design
Clinical trial with control group, simple sampling and sample size150, blind, randomized
Settings and conduct
The study population is all postmenopausal women aged 45-60 years referred to the clinics of Shiraz University of Medical Sciences and sampling will be done in an easy method based on purpose based on inclusion criteria and then divided into two intervention groups and a control group with a table of random numbers. it is going to happen. For people who have the criteria to enter the research and want to participate in the research, the questionnaire of demographic characteristics, the criterion of menopause will be completed and the research samples will be divided into two groups based on a random number table and a control group of 50 people. In this way, the intervention groups will take placebo capsules containing fennel and evening primrose oil and the control group will take placebo capsules. The contents of capsules A, B and C will be preserved for unknown samples and clinical caregivers, so the present study will be double-blind.
Participants/Inclusion and exclusion criteria
Entry requirements: 1-Failure to receive HRT 2- Not getting breast cancer treatment (hormone therapy) 3-Lack of surgery in ovarian tumors Non-arrival conditions: 1- Sudden increase or decrease of weight in the sample 2- Any reason that increases or decreases the level of estrogen in the body 3- For any reason, a person has to have hormone therapy 4- Any sign indicating that allergy to fennel and evening primrose oil has manifested itself 5- Examples that can cause menstrual disorder for any reason
Intervention groups
The intervention groups uses fennel capsules and evening primrose oil and a control group of placebo capsules
Main outcome variables
Menopause symptoms

General information

Reason for update
At the time of the project, the conditions for using another herbal medicine, namely evening primrose oil, were available, so a trial was conducted in three groups.
Acronym
IRCT registration information
IRCT registration number: IRCT20160404027207N2
Registration date: 2018-04-24, 1397/02/04
Registration timing: prospective

Last update: 2022-05-30, 1401/03/09
Update count: 1
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Fatemeh Ghavi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71543404059
Email address
ghavi.fatemeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-02, 1399/02/13
Expected recruitment end date
2020-11-18, 1399/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
Public title
Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of surgery in ovarian tumors Not getting breast cancer treatment (hormone therapy) Failure to receive HRT Women aged 45 to 60 years
Exclusion criteria:
Sudden increase or decrease of weight in the sample Any reason that increases or decreases the level of estrogen in the body For any reason, a person has to have hormone therapy Any sign indicating that allergy to fennel and evening primrose oil has manifested itself Examples that can cause menstrual disorder for any reason
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed by easy method based on purpose based on inclusion criteria and then divided into two groups of intervention and a control group using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention groups use capsules containing fennel and evening primrose oil and the control group used placebo capsules. All capsules will be in similar packages with codes A, B and C. The contents of capsules A, B, and C will be preserved for unknown samples and clinical caregivers. Therefore, the present study will be two blinds.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Faculty of Nursing and MidwiferyShiraz., Namazi Sqaure
City
shiraz
Province
Fars
Postal code
71944
Approval date
2017-12-09, 1396/09/18
Ethics committee reference number
IR. SUMS. REC. 1396. 136

Health conditions studied

1

Description of health condition studied
Menopausal and female climacteric states
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Menopause symptoms
Timepoint
Before intervention, two months after the intervention
Method of measurement
Hormones, SF36 General Measurement of Quality of Life, MRS A tool for assessing the severity of postmenopausal women's symptoms

Secondary outcomes

1

Description
Hormonal changes
Timepoint
Before intervention, two months after the intervention
Method of measurement
Elisa Methode

2

Description
Evaluation of the quality of life of postmenopausal women
Timepoint
Before intervention, two months after the intervention
Method of measurement
A general tool for assessing the quality of life SF36

3

Description
Evaluation of severity of symptoms of postmenopausal women
Timepoint
Before intervention, two months after the intervention
Method of measurement
A special tool for assessing the severity of symptoms of postmenopausal women MRS

Intervention groups

1

Description
Intervention groups one: The first group of 30 mg capsules of fennel extract for two months and orally twice a day.
Category
Prevention

2

Description
Intervention group two: 1000 mg capsules of evening primrose oil for two months and orally twice a day.
Category
Prevention

3

Description
Control group: Oral capsules of 100 mg placebo for 2 months twice a day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences clinics
Full name of responsible person
Ghavi Fatemeh
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
71944
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
ghavi.fatemeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Janghorban Roxana
Street address
Shiraz University of Medical Sciences, Setad Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
71944
Phone
+98 71 3230 5410
Fax
+98 71 3647 4252
Email
researchnu@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fatemeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fatemeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fateameh@yahoo.com

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
Not applicable
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Not applicable
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