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Protocol summary
Due to the increasing population of postmenopausal women and high prevalence of sleep disorders in these people, beside the general trend in the use of herbal medicines, careful consideration in order to achieve low risk and also more effective treatment for sleep disorders is essential.
This study is a triple-blind clinical trial (samples, the distributor of the drug and the person who will do analysis of data will not be aware of drugs) in which subjects according to inclusion criteria selected by Convenient sampling , and randomly placed in one of group.
Study will be done on 110 postmenopausal 50-60 years old women. Intended intervention is consumption of lemon balm capsules(capsules containing 250 mg extract of lemon balm twice a day) in one of group and consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for a month.
Instruments of this study are demographic questionnaire and Pittsburgh Sleep Quality Index that before and one month after starting taking medication in order to evaluate the symptoms of sleep disorders will be completed by the symptoms and finally data will be analyzed using of statistical tests.
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Due to the increasing population of postmenopausal women and high prevalence of sleep disorders in these people, beside the general trend in the use of herbal medicines, careful consideration in order to achieve low risk and also more effective treatment for sleep disorders is essential. This study is a triple-blind clinical trial (samples, the distributor of the drug and the person who will do analysis of data will not be aware of drugs) in which subjects according to inclusion criteria selected by Convenient sampling , and randomly placed in one of group. Study will be done on 110 postmenopausal 50-60 years old women. Intended intervention is consumption of lemon balm capsules(capsules containing 250 mg extract of lemon balm twice a day) in one of group and consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for a month. Instruments of this study are demographic questionnaire and Pittsburgh Sleep Quality Index that before and one month after starting taking medication in order to evaluate the symptoms of sleep disorders will be completed by the symptoms and finally data will be analyzed using of statistical tests.
با توجه به افزایش جمعیت زنان یائسه و شیوع بالای اختلال خواب در این افراد، از طرفی گرایش عمومی به استفاده از داروهای گیاهی، بررسی دقیق جهت دستیابی به درمان کم عارضه تر و درعین حال موثرتر جهت اختلالات خواب ضروری می باشد. لذا این مطالعه با هدف مقایسه تأثیر داروی گیاهی باد رنجبویه و بابونه بر اختلال خواب زنان یائسه طراحی شده است .
این پژوهش از نوع کارآزمایی بالینی سه سو کور (نمونه ها، فرد توزیع کننده دارو و فردی که تجزیه تحلیل داده ها را انجام خواهد داد از نوع دارو اطلاعی نخواهد داشت) می باشد که در آن افراد مورد پژوهش با توجه به معیارهای ورود با روش نمونه گیری در دسترس انتخاب شده و به صورت تصادفی در یکی از گروه ها قرار می گیرند.
پژوهش بر روی 110 زن یائسه 60-50 ساله در دو گروه انجام خواهد شد. مداخله مورد نظرمصرف کپسول بادرنجبویه(کپسول 250 میلی گرمی عصاره بادرنجبویه روزی دو بار) دریک گروه و کپسول بابونه(کپسول 400 میلی گرمی عصاره بابونه روزی دو بار) در گروه دیگر به مدت یک ماه می باشد. ابزار پژوهش فرم اطلاعات دموگرافیک و شاخص کیفیت خواب پیتزبرگ می باشد که قبل از انجام پژوهش و یک ماه بعد از شروع مصرف داروها جهت بررسی میزان بهبود علایم اختلال خواب توسط افراد تکمیل خواهدشد و در نهایت اطلاعات به دست آمده با استفاده از آزمون های آماری تجزیه و تحلیل خواهد شد.
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با توجه به افزایش جمعیت زنان یائسه و شیوع بالای اختلال خواب در این افراد، از طرفی گرایش عمومی به استفاده از داروهای گیاهی، بررسی دقیق جهت دستیابی به درمان کم عارضه تر و درعین حال موثرتر جهت اختلالات خواب ضروری می باشد. لذا این مطالعه با هدف مقایسه تأثیر داروی گیاهی باد رنجبویه و بابونه بر اختلال خواب زنان یائسه طراحی شده است . این پژوهش از نوع کارآزمایی بالینی سه سو کور (نمونه ها، فرد توزیع کننده دارو و فردی که تجزیه تحلیل داده ها را انجام خواهد داد از نوع دارو اطلاعی نخواهد داشت) می باشد که در آن افراد مورد پژوهش با توجه به معیارهای ورود با روش نمونه گیری در دسترس انتخاب شده و به صورت تصادفی در یکی از گروه ها قرار می گیرند. پژوهش بر روی 110 زن یائسه 60-50 ساله در دو گروه انجام خواهد شد. مداخله مورد نظرمصرف کپسول بادرنجبویه(کپسول 250 میلی گرمی عصاره بادرنجبویه روزی دو بار) دریک گروه و کپسول بابونه(کپسول 400 میلی گرمی عصاره بابونه روزی دو بار) در گروه دیگر به مدت یک ماه می باشد. ابزار پژوهش فرم اطلاعات دموگرافیک و شاخص کیفیت خواب پیتزبرگ می باشد که قبل از انجام پژوهش و یک ماه بعد از شروع مصرف داروها جهت بررسی میزان بهبود علایم اختلال خواب توسط افراد تکمیل خواهدشد و در نهایت اطلاعات به دست آمده با استفاده از آزمون های آماری تجزیه و تحلیل خواهد شد.
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Comparison of lemon Balm and chamomile on sleep disorders of menopausal women
Comparison of lemon Balm and chamomile on sleep disorders of menopausal women
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مقایسه تأثیر باد رنجبویه و بابونه بر اختلال خواب زنان یائسه
مقایسه تأثیر باد رنجبویه و بابونه بر اختلال خواب زنان یائسه
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This study is a triple-blind clinical trial.subjects will be selected by convenience sampling method then they will be randomly assigned to one of the groups. study will be conducted on 110 postmenopausal 50-60 years old women. intervention includes taking lemon balm capsule in one group and chamomile capsule in other group for one month. one month after starting medication, Pittsburgh Sleep Quality Index will be completed by subjects and finally, data will be analyzed using statistical tests.
This study is a triple-blind clinical trial.subjects will be selected by convenience sampling method then they will be randomly assigned to one of the groups. study will be conducted on 110 postmenopausal 50-60 years old women. intervention includes taking lemon balm capsule in one group and chamomile capsule in other group for one month. one month after starting medication, Pittsburgh Sleep Quality Index will be completed by subjects and finally, data will be analyzed using statistical tests.
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این پژوهش از نوع کارآزمایی بالینی سه سو کور می باشد. افراد مورد پژوهش با روش نمونه گیری در دسترس انتخاب شده سپس به صورت تصادفی در یکی از گروه ها قرار خواهند گرفت. پژوهش بر روی 110 زن یائسه 60-50 ساله انجام خواهد شد. مداخله شامل مصرف کپسول بادرنجبویه دریک گروه و کپسول بابونهدر گروه دیگر به مدت یک ماه می باشد. یک ماه بعد از شروع مصرف داروها شاخص کیفیت خواب پیتزبرگ توسط نمونه ها تکمیل خواهدشد و در نهایت اطلاعات با استفاده از آزمون های آماری تجزیه و تحلیل خواهد شد.
این پژوهش از نوع کارآزمایی بالینی سه سو کور می باشد. افراد مورد پژوهش با روش نمونه گیری در دسترس انتخاب شده سپس به صورت تصادفی در یکی از گروه ها قرار خواهند گرفت. پژوهش بر روی 110 زن یائسه 60-50 ساله انجام خواهد شد. مداخله شامل مصرف کپسول بادرنجبویه دریک گروه و کپسول بابونهدر گروه دیگر به مدت یک ماه می باشد. یک ماه بعد از شروع مصرف داروها شاخص کیفیت خواب پیتزبرگ توسط نمونه ها تکمیل خواهدشد و در نهایت اطلاعات با استفاده از آزمون های آماری تجزیه و تحلیل خواهد شد.
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The study will be conducted on 110 postmenopausal 50-60 years old women referred to Arak health centers. intervention includes taking lemon balm capsule(250 mg extract of lemon balm) in one group and chamomile capsule(400 mg extract of Chamomile) in other group for one month
and twice a day.
The study will be conducted on 110 postmenopausal 50-60 years old women referred to Arak health centers. intervention includes taking lemon balm capsule(250 mg extract of lemon balm) in one group and chamomile capsule(400 mg extract of Chamomile) in other group for one month and twice a day.
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مطالعه بر روی 110 زن یائسه 60-50 ساله مراجعه کننده به مراکز بهداشت اراک انجام خواهد شد. مداخله شامل مصرف کپسول بادرنجبویه(250 میلی گرم عصاره بادرنجبویه) دریک گروه و کپسول بابونه( 400 میلی گرم عصاره بابونه) در گروه دیگر روزی دو بار به مدت یک ماه می باشد.
مطالعه بر روی 110 زن یائسه 60-50 ساله مراجعه کننده به مراکز بهداشت اراک انجام خواهد شد. مداخله شامل مصرف کپسول بادرنجبویه(250 میلی گرم عصاره بادرنجبویه) دریک گروه و کپسول بابونه( 400 میلی گرم عصاره بابونه) در گروه دیگر روزی دو بار به مدت یک ماه می باشد.
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Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire,lack of physical and mental illness affecting sleep,not taking drugs that affect sleep quality.
Unpredictably significant change in sleep conditions Including travelling
Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire,lack of physical and mental illness affecting sleep,not taking drugs that affect sleep quality. Unpredictably significant change in sleep conditions Including travelling
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معیارهای ورود: اختلال خواب خفیف و متوسط بر اساس پرسشنامه کیفیت خواب پیتزبرگ، فقدان بیماری جسمی و روانی موثر بر روی کیفیت خواب ، عدم مصرف داروهای موثر بر کیفیت خواب
معیارهای خروج: تغییر قابل توجه شرایط خواب به صورت غیر قابل پیش بینی از جمله مسافرت
معیارهای ورود: اختلال خواب خفیف و متوسط بر اساس پرسشنامه کیفیت خواب پیتزبرگ، فقدان بیماری جسمی و روانی موثر بر روی کیفیت خواب ، عدم مصرف داروهای موثر بر کیفیت خواب معیارهای خروج: تغییر قابل توجه شرایط خواب به صورت غیر قابل پیش بینی از جمله مسافرت
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Consumption of lemon balm in group 1 and chamomile in group 2
Consumption of lemon balm in group 1 and chamomile in group 2
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مصرف بادرنجبویه در گروه 1و بابونه در گروه 2
مصرف بادرنجبویه در گروه 1و بابونه در گروه 2
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sleep hygiene
sleep hygiene
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کیفیت خواب
کیفیت خواب
General information
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2015-08-23, 1394/06/01
2015-08-23 00:00:00
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2015-12-22, 1394/10/01
2015-12-22 00:00:00
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2015-12-22, 1394/10/01
2015-12-22 00:00:00
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To correct title spelling mistake
To correct title spelling mistake
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برای اصلاح اشتباه املایی عنوان
برای اصلاح اشتباه املایی عنوان
Comparison of Lemon Blam and chamomile effect on sleep disorders in menopausal women
Comparison of Lemon Balm and chamomile effect on sleep disorders in menopausal women
Comparison of Lemon BlamBalm and chamomile effect on sleep disorders in menopausal women
Comparison of effectiveness of lemon Blam and chamomile on sleep disorders in menopausal women
Comparison of effectiveness of lemon Balm and chamomile on sleep disorders in menopausal women
Comparison of effectiveness of lemon BlamBalm and chamomile on sleep disorders in menopausal women
menopause women
Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire
lack of physical and mental illness affecting sleep
not taking drugs that affect sleep quality
menopause women Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire lack of physical and mental illness affecting sleep not taking drugs that affect sleep quality
زنان یائسه
اختلال خواب خفیف و متوسط بر اساس پرسشنامه کیفیت خواب پیتزبرگ
فقدان بیماری جسمی و روانی موثر بر روی کیفیت خواب
عدم مصرف داروهای موثر بر کیفیت خواب
زنان یائسه اختلال خواب خفیف و متوسط بر اساس پرسشنامه کیفیت خواب پیتزبرگ فقدان بیماری جسمی و روانی موثر بر روی کیفیت خواب عدم مصرف داروهای موثر بر کیفیت خواب
Unpredictably significant change in sleep conditions Including travelling, relocation
Unpredictably significant change in sleep conditions Including travelling, relocation
تغییر قابل توجه شرایط خواب به صورت غیر قابل پیش بینی از جمله مسافرت
تغییر قابل توجه شرایط خواب به صورت غیر قابل پیش بینی از جمله مسافرت
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Samples were selected by convenience sampling and were randomly divided into intervention and control groups using random number table.
Samples were selected by convenience sampling and were randomly divided into intervention and control groups using random number table.
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ابتدا نمونه ها به روش در دسترس انتخاب شدند و به روش تصادفی ساده با استفاده از جدول اعداد تصادفی در دو گروه مداخله و کنترل قرار گرفتند.
ابتدا نمونه ها به روش در دسترس انتخاب شدند و به روش تصادفی ساده با استفاده از جدول اعداد تصادفی در دو گروه مداخله و کنترل قرار گرفتند.
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Subjects, researcher and data analyser were blinded
Subjects, researcher and data analyser were blinded
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نمونه ها، محقق و آنالیز کننده داده ها کورسازی شدند
نمونه ها، محقق و آنالیز کننده داده ها کورسازی شدند
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Recruitment centers
#1
Name of recruitment center - English: Clinics in Arak affiliated to Arak university of Medical Sciences
Name of recruitment center - Persian: درمانگاه های وابسته به دانشگاه علوم پزشکی اراک شهر اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Street address - English: Arak
Street address - Persian: اراک
City - English: arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Health centers in Arak
Name of recruitment center - Persian: مراکز بهداشت اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Street address - English: Arak
Street address - Persian: اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 6055
Fax: +98 86 3313 3147
Email: zeinab_alizadeh88@yahoo.com
Web page address:
Name of recruitment center - English: ClinicsHealth centers in Arak affiliated to Arak university of Medical Sciences Name of recruitment center - Persian: درمانگاه های وابسته به دانشگاه علوم پزشکی اراک شهرمراکز بهداشت اراک Full name of responsible person - English: Zeinab Alizadeh Full name of responsible person - Persian: زینب علیزاده Street address - English: Arak Street address - Persian: اراک City - English: arakArak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3313 6055 Fax: +98 86 3313 3147 Email: zeinab_alizadeh88@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for research of Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Dr Ghazavi
Full name of responsible person - Persian: آقای دکتر قضاوی
Street address - English: Department Of research&Technology, Sardasht, Arak
Street address - Persian: اراک - سردشت- معاونت تحقیقات و فن آوری
City - English: Arak
City - Persian: اراک
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 of Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Dr Ghazavi
Full name of responsible person - Persian: آقای دکتر قضاوی
Street address - English: Department Of research&Technology, Sardasht, Arak
Street address - Persian: اراک - سردشت- معاونت تحقیقات و فن آوری
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 6055
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for research of Arak University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک Full name of responsible person - English: Dr Ghazavi Full name of responsible person - Persian: آقای دکتر قضاوی Street address - English: Department Of research&Technology, Sardasht, Arak Street address - Persian: اراک - سردشت- معاونت تحقیقات و فن آوری City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3313 6055 Fax: Email: zeinab_alizadeh88@yahoo.com Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSC in Nursing
Position - Persian: کارشناسی ارشد پرستاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak
Street address - Persian: اراک- سردشت، دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +86 34173503
Mobile: +91 43237870
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSC in Nursing
Position - Persian: کارشناسی ارشد پرستاری
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak
Street address - Persian: اراک- سردشت، دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +86 34173503
Mobile: +91 43237870
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arak University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک Full name of responsible person - English: Zeinab Alizadeh Full name of responsible person - Persian: زینب علیزاده Position - English: MSC in Nursing Position - Persian: کارشناسی ارشد پرستاری Latest degree: master Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak Street address - Persian: اراک- سردشت، دانشکده پرستاری و مامایی City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +86 34173503 Mobile: +91 43237870 Fax: Email: zeinab_alizadeh88@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSc in Nursing
Position - Persian: کارشناسی ارشد پرستاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery faculty, Sardasht, Arak
Street address - Persian: اراک- سردشت- دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 86 3417 3503
Mobile: +98 914 323 7870
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSc in Nursing
Position - Persian: کارشناسی ارشد پرستاری
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery faculty, Sardasht, Arak
Street address - Persian: اراک- سردشت- دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3503
Mobile: +98 914 323 7870
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arak University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک Full name of responsible person - English: Zeinab Alizadeh Full name of responsible person - Persian: زینب علیزاده Position - English: MSc in Nursing Position - Persian: کارشناسی ارشد پرستاری Latest degree: master Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing&Midwifery faculty, Sardasht, Arak Street address - Persian: اراک- سردشت- دانشکده پرستاری و مامایی City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3503 Mobile: +98 914 323 7870 Fax: Email: zeinab_alizadeh88@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSc in Nursing
Position - Persian: کارشناسی ارشد پرستاری/ عضو هیئت علمی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak
Street address - Persian: اراک سردشت دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 86 3417 3503
Mobile: +98 914 323 7870
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Arak University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Zeinab Alizadeh
Full name of responsible person - Persian: زینب علیزاده
Position - English: MSc in Nursing
Position - Persian: کارشناسی ارشد پرستاری/ عضو هیئت علمی
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak
Street address - Persian: اراک سردشت دانشکده پرستاری و مامایی
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3503
Mobile: +98 914 323 7870
Fax:
Email: zeinab_alizadeh88@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arak University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک Full name of responsible person - English: Zeinab Alizadeh Full name of responsible person - Persian: زینب علیزاده Position - English: MSc in Nursing Position - Persian: کارشناسی ارشد پرستاری/ عضو هیئت علمی Latest degree: master Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing&Midwifery Faculty, Sardasht, Arak Street address - Persian: اراک سردشت دانشکده پرستاری و مامایی City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3503 Mobile: +98 914 323 7870 Fax: Email: zeinab_alizadeh88@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
yes
yes
yes
yes
na
na
na
na
empty
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empty
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Protocol summary
Study aim
Comparison of lemon Balm and chamomile on sleep disorders of menopausal women
Design
This study is a triple-blind clinical trial.subjects will be selected by convenience sampling method then they will be randomly assigned to one of the groups. study will be conducted on 110 postmenopausal 50-60 years old women. intervention includes taking lemon balm capsule in one group and chamomile capsule in other group for one month. one month after starting medication, Pittsburgh Sleep Quality Index will be completed by subjects and finally, data will be analyzed using statistical tests.
Settings and conduct
The study will be conducted on 110 postmenopausal 50-60 years old women referred to Arak health centers. intervention includes taking lemon balm capsule(250 mg extract of lemon balm) in one group and chamomile capsule(400 mg extract of Chamomile) in other group for one month
and twice a day.
Participants/Inclusion and exclusion criteria
Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire,lack of physical and mental illness affecting sleep,not taking drugs that affect sleep quality.
Unpredictably significant change in sleep conditions Including travelling
Intervention groups
Consumption of lemon balm in group 1 and chamomile in group 2
Main outcome variables
sleep hygiene
General information
Reason for update
To correct title spelling mistake
Acronym
IRCT registration information
IRCT registration number:IRCT2015073110076N5
Registration date:2015-09-04, 1394/06/13
Registration timing:registered_while_recruiting
Last update:2019-11-05, 1398/08/14
Update count:1
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Maryam Saeedi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
m.saeedi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
2015-08-23, 1394/06/01
Actual recruitment end date
2015-12-22, 1394/10/01
Trial completion date
2015-12-22, 1394/10/01
Scientific title
Comparison of effectiveness of lemon Balm and chamomile on sleep disorders in menopausal women
Public title
Comparison of Lemon Balm and chamomile effect on sleep disorders in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
menopause women
Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire
lack of physical and mental illness affecting sleep
not taking drugs that affect sleep quality
Exclusion criteria:
Unpredictably significant change in sleep conditions Including travelling, relocation
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by convenience sampling and were randomly divided into intervention and control groups using random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Subjects, researcher and data analyser were blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University Of Medical Sciences
Street address
Vice Chancellor for research of Arak University of Medical Sciences, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
IR.ARAKMU.REC.1394.78
Health conditions studied
1
Description of health condition studied
Seep disorder
ICD-10 code
G47
ICD-10 code description
Other sleep disorders
Primary outcomes
1
Description
sleep disorder
Timepoint
after study and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
" Intervention group1": Consumption of lemon balm capsules(capsules Containing 250 mg extract of lemon balm twice a day) in one of group for one month
Category
Treatment - Drugs
2
Description
"Intervention group 2": Consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Arak
Full name of responsible person
Zeinab Alizadeh
Street address
Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
zeinab_alizadeh88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr Ghazavi
Street address
Department Of research&Technology, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
zeinab_alizadeh88@yahoo.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 of Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSC in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing&Midwifery Faculty, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+86 34173503
Fax
Email
zeinab_alizadeh88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing&Midwifery faculty, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
Email
zeinab_alizadeh88@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing&Midwifery Faculty, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
Email
zeinab_alizadeh88@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document