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Protocol summary
Purpose: The effect of Specific Dietary Interventions in Postprandial Distress Syndrome. Design: This study is a randomized without placebo-controlled. People in study: Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital. Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding. Target sample size: 60. Intervention: This study will include Two groups. Each group will consist of 30 Postprandial Distress Syndrome patients, One group with adlibitum diet and intervention group with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes will be performed. Primary outcome: severity of Functional Dyspepsia.
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Purpose: The effect of Specific Dietary Interventions in Postprandial Distress Syndrome. Design: This study is a randomized without placebo-controlled. People in study: Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital. Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding. Target sample size: 60. Intervention: This study will include Two groups. Each group will consist of 30 Postprandial Distress Syndrome patients, One group with adlibitum diet and intervention group with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes will be performed. Primary outcome: severity of Functional Dyspepsia.
هدف مطالعه: تعیین تأثیر رژیم غذایی خاص بر بیماران مبتلا به سوء هاضمۀ عملکردي نوع نفاخ (PDS). طراحی انجام مطالعه: کارآزمایی بالینی تصادفی، بدون کنترل دارونما. جمعیت مورد مطالعه: زنان و مردان 75-18 سالۀ مبتلا به سوء هاضمه عملکردی نوع نفاخ (PDS) مراجعه کننده به درمانگاه گوارش بیمارستان آیت الله طالقانی. معیارهای ورود: بیماران با علائم احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه. معیارهای خروج: داشتن بيماري های عضوي و سیستمیک؛ حاملگی و شیردهی. حجم نمونه: 60. مداخله: این مطالعه شامل دو گروه می باشد. در هر گروه 30 بیمار دارای علایم سوءهاضمه عملکردی نوع نفّاخ (PDS) قرار دارند، یک گروه بدون مداخله و با رژیم غذایی معمول می باشد و به گروه مداخله به مدت دو هفته رژیم غذایی خاص بر پایۀ توصیه های طب سنتی ایران داده می شود. پیگیری علائم بیماران تا 8 هفته می باشد. پیامد اولیه: شدت سوء هاضمه عملکردی.
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هدف مطالعه: تعیین تأثیر رژیم غذایی خاص بر بیماران مبتلا به سوء هاضمۀ عملکردي نوع نفاخ (PDS). طراحی انجام مطالعه: کارآزمایی بالینی تصادفی، بدون کنترل دارونما. جمعیت مورد مطالعه: زنان و مردان 75-18 سالۀ مبتلا به سوء هاضمه عملکردی نوع نفاخ (PDS) مراجعه کننده به درمانگاه گوارش بیمارستان آیت الله طالقانی. معیارهای ورود: بیماران با علائم احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه. معیارهای خروج: داشتن بيماري های عضوي و سیستمیک؛ حاملگی و شیردهی. حجم نمونه: 60. مداخله: این مطالعه شامل دو گروه می باشد. در هر گروه 30 بیمار دارای علایم سوءهاضمه عملکردی نوع نفّاخ (PDS) قرار دارند، یک گروه بدون مداخله و با رژیم غذایی معمول می باشد و به گروه مداخله به مدت دو هفته رژیم غذایی خاص بر پایۀ توصیه های طب سنتی ایران داده می شود. پیگیری علائم بیماران تا 8 هفته می باشد. پیامد اولیه: شدت سوء هاضمه عملکردی.
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The effect of Specific Dietary Interventions in Postprandial Distress Syndrome.
The effect of Specific Dietary Interventions in Postprandial Distress Syndrome.
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تعیین تأثیر رژیم غذایی خاص بر بیماران مبتلا به سوء هاضمۀ عملکردي نوع نفاخ (PDS)
تعیین تأثیر رژیم غذایی خاص بر بیماران مبتلا به سوء هاضمۀ عملکردي نوع نفاخ (PDS)
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This study is a randomized without placebo-controlled.
This study is a randomized without placebo-controlled.
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کارآزمایی بالینی تصادفی، بدون کنترل دارونما.
کارآزمایی بالینی تصادفی، بدون کنترل دارونما.
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This study include Two groups. Each group consist of Postprandial Distress Syndrome patients, One group with adlibitum diet (27 patients) and intervention group (29 patients) with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes performed.
This study include Two groups. Each group consist of Postprandial Distress Syndrome patients, One group with adlibitum diet (27 patients) and intervention group (29 patients) with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes performed.
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این مطالعه شامل دو گروه می باشد. در هر گروه بیماران دارای علایم سوءهاضمه عملکردی نوع نفّاخ (PDS) قرار دارند، یک گروه بدون مداخله (27بيمار) و با رژیم غذایی معمول می باشد و به گروه مداخله (29 بيمار) به مدت دو هفته رژیم غذایی خاص بر پایۀ توصیه های طب سنتی ایران داده شد. پیگیری علائم بیماران تا 8 هفته انجام شد
این مطالعه شامل دو گروه می باشد. در هر گروه بیماران دارای علایم سوءهاضمه عملکردی نوع نفّاخ (PDS) قرار دارند، یک گروه بدون مداخله (27بيمار) و با رژیم غذایی معمول می باشد و به گروه مداخله (29 بيمار) به مدت دو هفته رژیم غذایی خاص بر پایۀ توصیه های طب سنتی ایران داده شد. پیگیری علائم بیماران تا 8 هفته انجام شد
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Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding.
Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding.
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معیارهای ورود: بیماران با علائم احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه. معیارهای خروج: داشتن بيماري های عضوي و سیستمیک؛ حاملگی و شیردهی
معیارهای ورود: بیماران با علائم احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه. معیارهای خروج: داشتن بيماري های عضوي و سیستمیک؛ حاملگی و شیردهی
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Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital.
Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital.
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زنان و مردان 75-18 سالۀ مبتلا به سوء هاضمه عملکردی نوع نفاخ (PDS) مراجعه کننده به درمانگاه گوارش بیمارستان آیت الله طالقانی.
زنان و مردان 75-18 سالۀ مبتلا به سوء هاضمه عملکردی نوع نفاخ (PDS) مراجعه کننده به درمانگاه گوارش بیمارستان آیت الله طالقانی.
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severity of Functional Dyspepsia.
severity of Functional Dyspepsia.
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شدت سوء هاضمه عملکردی.
شدت سوء هاضمه عملکردی.
General information
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56
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2017-04-08, 1396/01/19
2017-04-08 00:00:00
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2018-10-29, 1397/08/07
2018-10-29 00:00:00
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2018-10-29, 1397/08/07
2018-10-29 00:00:00
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Updates are performed to fill in the blanks
Updates are performed to fill in the blanks
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جهت تكميل قسمت هاي خالي بروزرساني انجام مي شود.
جهت تكميل قسمت هاي خالي بروزرساني انجام مي شود.
patients with 18-75 years old;
Willing to cooperate;
Early Satiety or bothersome postprandial fullness more than 3 months;
Without Organic Disorders on physical examination;
normal Endoscopic.
patients with 18-75 years old; Willing to cooperate; Early Satiety or bothersome postprandial fullness more than 3 months; Without Organic Disorders on physical examination; normal Endoscopic.
بیماران 75-18 سال؛
متمایل به همکاری؛
احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه؛
سالم از نظر ارگانیک؛
وجود آندوسکوپی نرمال.
بیماران 75-18 سال؛ متمایل به همکاری؛ احساس سيري زودرس یا احساس سنگيني مزاحم بعد از غذا بیش از سه ماه؛ سالم از نظر ارگانیک؛ وجود آندوسکوپی نرمال.
Patients with organic disorders; T
he use of Chemicals and Herbals any other medication;
History of Abdominal surgeries;
History of bloody diarrhea;
Pregnancy and breast feeding;
Lack of interest in work;
Not sign the consent.
Patients with organic disorders; T he use of Chemicals and Herbals any other medication; History of Abdominal surgeries; History of bloody diarrhea; Pregnancy and breast feeding; Lack of interest in work; Not sign the consent.
داشتن بيماري عضوي؛
استفاده هر نوع داروی شیمیایی و گیاهی دیگر؛
سابقه عمل جراحی شکمی؛
اسهال خونی؛
دوران حاملگی و شیردهی؛
عدم علاقه به ادامه کار؛
عدم امضای رضایت نامه.
داشتن بيماري عضوي؛ استفاده هر نوع داروی شیمیایی و گیاهی دیگر؛ سابقه عمل جراحی شکمی؛ اسهال خونی؛ دوران حاملگی و شیردهی؛ عدم علاقه به ادامه کار؛ عدم امضای رضایت نامه.
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Randomization method: blocking
Randomization unit: individual
In this method, each person was considered as a block.
Because there were two groups of intervention (a) and control (b), it was determined based on quadruple blocks and by drawing blocks, and thus each person was placed in the intervention and control group. for example:
A B A B
B A A B
B B A A ,......
Random allocation software was used for randomization.
Randomization method: blocking Randomization unit: individual In this method, each person was considered as a block. Because there were two groups of intervention (a) and control (b), it was determined based on quadruple blocks and by drawing blocks, and thus each person was placed in the intervention and control group. for example: A B A B B A A B B B A A ,...... Random allocation software was used for randomization.
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روش تصادفی سازی : بلوک بندي
واحد تصادفی سازی: فردی
در اين روش هر فرد به عنوان يك بلوك در نظر گرفته شد. چون دو گروه مداخله (الف) و كنترل (ب) وجود داشت بر اساس بلوك هاي چهارتايي و با قرعه بلوك ها مشخص گرديد و به اين ترتيب هر فرد مراجعه كننده در گروه مداخله و كنترل قرار مي گرفت. بطور مثال :
الف ب الف ب
ب الف الف ب
ب ب الف الف و .....
براي تصادفی سازی، از نرم افزارهاي توليد توالي تصادفي ( Random allocation software ) استفاده شد.
روش تصادفی سازی : بلوک بندي واحد تصادفی سازی: فردی در اين روش هر فرد به عنوان يك بلوك در نظر گرفته شد. چون دو گروه مداخله (الف) و كنترل (ب) وجود داشت بر اساس بلوك هاي چهارتايي و با قرعه بلوك ها مشخص گرديد و به اين ترتيب هر فرد مراجعه كننده در گروه مداخله و كنترل قرار مي گرفت. بطور مثال : الف ب الف ب ب الف الف ب ب ب الف الف و ..... براي تصادفی سازی، از نرم افزارهاي توليد توالي تصادفي ( Random allocation software ) استفاده شد.
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Intervention groups
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Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks
Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks. In this diet, based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks.
Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks. In this diet, based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks.
گروه مداخله: رژیم غذایی خاص بر پایۀ طب سنتی ایران به مدت دو هفته
گروه مداخله: رژیم غذایی خاص بر پایۀ طب سنتی ایران به مدت دو هفته . در اين رژيم غذايي بر اساس گروه هاي غذايي هرم غذایی نوین و با رعايت اصل تنوع و تعادل، غذاهای سرد و تر، سنگین، دیرهضم یا بدهضم، و مضرّ معده بر پايه منابع معتبر طب سنتي ايران از رژیم غذایی بیماران، حذف و ماده غذایی مناسب و معادل آن در همان گروه جایگزین مي شود. اين رژيم به مدت دو هفته به بيماران گروه مداخله داده مي شود.
گروه مداخله: رژیم غذایی خاص بر پایۀ طب سنتی ایران به مدت دو هفته . در اين رژيم غذايي بر اساس گروه هاي غذايي هرم غذایی نوین و با رعايت اصل تنوع و تعادل، غذاهای سرد و تر، سنگین، دیرهضم یا بدهضم، و مضرّ معده بر پايه منابع معتبر طب سنتي ايران از رژیم غذایی بیماران، حذف و ماده غذایی مناسب و معادل آن در همان گروه جایگزین مي شود. اين رژيم به مدت دو هفته به بيماران گروه مداخله داده مي شود.
#2
گروه کنترل: ادامه رژیم غذایی قبلی بدون محدودیت
گروه کنترل: ادامه رژیم غذایی قبلی بدون محدودیت.
گروه کنترل: ادامه رژیم غذایی قبلی بدون محدودیت.
Recruitment centers
#1
Name of recruitment center - English: Ayatollah Taleghani Hospital
Name of recruitment center - Persian: بیمارستان آیت الله طالقانی
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Street address - English: Velenjak St., Shahid Chamran Highway
Street address - Persian: ولنجک، بزرگراه شهید چمران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ayatollah Taleghani Hospital
Name of recruitment center - Persian: بیمارستان آیت الله طالقانی
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Street address - English: Velenjak St., Shahid Chamran Highway
Street address - Persian: ولنجک، بزرگراه شهید چمران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985711151
Phone: +98 21 2243 2560
Fax:
Email: taleghanihospital@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Ayatollah Taleghani Hospital Name of recruitment center - Persian: بیمارستان آیت الله طالقانی Full name of responsible person - English: Fereshteh Nouri Full name of responsible person - Persian: فرشته نوری Street address - English: Velenjak St., Shahid Chamran Highway Street address - Persian: ولنجک، بزرگراه شهید چمران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985711151 Phone: +98 21 2243 2560 Fax: Email: taleghanihospital@sbmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Mohsen Naseri
Full name of responsible person - Persian: دکتر محسن ناصری
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Mohsen Naseri
Full name of responsible person - Persian: دکتر محسن ناصری
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 3319118651
Phone: +98 21 5121 5080
Fax:
Email: info@shahed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shahed University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد Full name of responsible person - English: Mohsen Naseri Full name of responsible person - Persian: دکتر محسن ناصری Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave. Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 3319118651 Phone: +98 21 5121 5080 Fax: Email: info@shahed.ac.ir 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: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Position - English: Traditional Iranian Medicine PHD student
Position - Persian: دستیار تخصصی طب سنتی ایران
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2288 2521
Mobile: +98 919 550 6260
Fax:
Email: fdr.nouri@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Position - English: Traditional Iranian Medicine PHD student
Position - Persian: دستیار تخصصی طب سنتی ایران
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3319118651
Phone: +98 21 2288 2521
Mobile: +98 919 550 6260
Fax:
Email: fdr.nouri@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahed University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد Full name of responsible person - English: Fereshteh Nouri Full name of responsible person - Persian: فرشته نوری Position - English: Traditional Iranian Medicine PHD student Position - Persian: دستیار تخصصی طب سنتی ایران Latest degree: phd Area of specialty/work: 058 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave. Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3319118651 Phone: +98 21 2288 2521 Mobile: +98 919 550 6260 Fax: Email: fdr.nouri@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Saeed Abdi
Full name of responsible person - Persian: دکتر سعید عبدی
Position - English: Gastroenterologist
Position - Persian: فوق تخصص گوارش
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ayatollah Taleghani Hospital
Street address - Persian: بیمارستان آیت الله طالقانی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2243 2561
Mobile:
Fax:
Email: saeedabdi75@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Saeed Abdi
Full name of responsible person - Persian: دکتر سعید عبدی
Position - English: Gastroenterologist
Position - Persian: فوق تخصص گوارش
Latest degree: sub_specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ayatollah Taleghani Hospital
Street address - Persian: بیمارستان آیت الله طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985711151
Phone: +98 21 2243 2561
Mobile: +98 912 137 3692
Fax:
Email: saeedabdi75@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Saeed Abdi Full name of responsible person - Persian: دکتر سعید عبدی Position - English: Gastroenterologist Position - Persian: فوق تخصص گوارش Latest degree: sub_specialist Area of specialty/work: 040 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ayatollah Taleghani Hospital Street address - Persian: بیمارستان آیت الله طالقانی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985711151 Phone: +98 21 2243 2561 Mobile: +98 912 137 3692 Fax: Email: saeedabdi75@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Position - English: Traditional Iranian Medicine PHD student
Position - Persian: دستیار تخصصی طب سنتی ایران
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2288 2521
Mobile: +98 919 550 6260
Fax:
Email: fdr.nouri@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahed University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد
Full name of responsible person - English: Fereshteh Nouri
Full name of responsible person - Persian: فرشته نوری
Position - English: Traditional Iranian Medicine PHD student
Position - Persian: دستیار تخصصی طب سنتی ایران
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave.
Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3319118651
Phone: +98 21 2288 2521
Mobile: +98 919 550 6260
Fax:
Email: fdr.nouri@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahed University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهد Full name of responsible person - English: Fereshteh Nouri Full name of responsible person - Persian: فرشته نوری Position - English: Traditional Iranian Medicine PHD student Position - Persian: دستیار تخصصی طب سنتی ایران Latest degree: phd Area of specialty/work: 058 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tim Health care, Third Dashtestan Ave, Shariati Ave. Street address - Persian: خیابان شریعتی، دشتستان سوم، سلامتگاه طب سنتی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3319118651 Phone: +98 21 2288 2521 Mobile: +98 919 550 6260 Fax: Email: fdr.nouri@gmail.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
Some data, such as information about the main outcome or the like, can be shared.
Some data, such as information about the main outcome or the like, can be shared.
empty
بخشی از داده ها نظیر اطلاعات مربوط به پیامد اصلی یا امثال آن امکان اشتراک گذاری دارد.
بخشی از داده ها نظیر اطلاعات مربوط به پیامد اصلی یا امثال آن امکان اشتراک گذاری دارد.
empty
The description includes both the time period and the start date of the access
The description includes both the time period and the start date of the access
empty
توصیف هم بازه زمانی و هم تاریخ شروع دسترسی را شامل مي شود
توصیف هم بازه زمانی و هم تاریخ شروع دسترسی را شامل مي شود
empty
Researchers working in academic and scientific institutions
Researchers working in academic and scientific institutions
empty
محققین شاغل در موسسات دانشگاهی و علمي
محققین شاغل در موسسات دانشگاهی و علمي
empty
In the form of publication of an article
In the form of publication of an article
empty
به صورت چاپ و انتشار مقاله
به صورت چاپ و انتشار مقاله
empty
To the site of reputable domestic and foreign magazines
To the site of reputable domestic and foreign magazines
empty
به سايت مجلات معتبر داخلي و خارجي
به سايت مجلات معتبر داخلي و خارجي
empty
It depends on the acceptance and publication of the article in the intended journal
It depends on the acceptance and publication of the article in the intended journal
empty
بستگي به پذيرش و انتشار مقاله در مجله موردنظر دارد
بستگي به پذيرش و انتشار مقاله در مجله موردنظر دارد
Protocol summary
Study aim
The effect of Specific Dietary Interventions in Postprandial Distress Syndrome.
Design
This study is a randomized without placebo-controlled.
Settings and conduct
This study include Two groups. Each group consist of Postprandial Distress Syndrome patients, One group with adlibitum diet (27 patients) and intervention group (29 patients) with special diet based on the recommendations of the Traditional Iranian Medicine for two weeks. During the subsequent 8 weeks, follow-up observations of primary and secondary outcomes performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Early Satiety or bothersome postprandial fullness more than 3 months. Exclusion criteria: Patients with organic and systemic disorders; pregnancy and breast feeding.
Intervention groups
Mails and femails 18-75 years old who Referred to gastrointestinal Clinic in Ayatollah Taleghani Hospital.
Main outcome variables
severity of Functional Dyspepsia.
General information
Reason for update
Updates are performed to fill in the blanks
Acronym
IRCT registration information
IRCT registration number:IRCT2015050322049N1
Registration date:2015-08-06, 1394/05/15
Registration timing:prospective
Last update:2020-07-28, 1399/05/07
Update count:1
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Fereshteh Nouri
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3333
Email address
fdr.nouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahed University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
2017-04-08, 1396/01/19
Actual recruitment end date
2018-10-29, 1397/08/07
Trial completion date
2018-10-29, 1397/08/07
Scientific title
Assessment of effect of Specific Dietary Interventions on severity of Dyspepsia in patients with Postprandial Distress Syndrom
Public title
The effect of Specific Dietary Interventions in Postprandial Distress Syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with 18-75 years old;
Willing to cooperate;
Early Satiety or bothersome postprandial fullness more than 3 months;
Without Organic Disorders on physical examination;
normal Endoscopic.
Exclusion criteria:
Patients with organic disorders; T
he use of Chemicals and Herbals any other medication;
History of Abdominal surgeries;
History of bloody diarrhea;
Pregnancy and breast feeding;
Lack of interest in work;
Not sign the consent.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: blocking
Randomization unit: individual
In this method, each person was considered as a block.
Because there were two groups of intervention (a) and control (b), it was determined based on quadruple blocks and by drawing blocks, and thus each person was placed in the intervention and control group. for example:
A B A B
B A A B
B B A A ,......
Random allocation software was used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University of Medical Sciences
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
Shahed.REC.1393.45
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
k30
ICD-10 code description
Indigestion
Primary outcomes
1
Description
Severity Assessment of Dyspepsia
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
Secondary outcomes
1
Description
Postprandial fullness
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
2
Description
Early Satiety
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
3
Description
Bloating
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
4
Description
Nausea
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
5
Description
Belching
Timepoint
At baseline, 2 and 8 weeks after starting the intervention
Method of measurement
The Gastrointestinal Symptom Scale
Intervention groups
1
Description
Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks. In this diet, based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks.
Category
Lifestyle
2
Description
Control group: continue previous diet without restriction
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Fereshteh Nouri
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Mohsen Naseri
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed 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
Shahed University of Medical Sciences
Full name of responsible person
Fereshteh Nouri
Position
Traditional Iranian Medicine PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 2288 2521
Fax
Email
fdr.nouri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Abdi
Position
Gastroenterologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2561
Fax
Email
saeedabdi75@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Fereshteh Nouri
Position
Traditional Iranian Medicine PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tim Health care, Third Dashtestan Ave, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 2288 2521
Fax
Email
fdr.nouri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
The description includes both the time period and the start date of the access
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In the form of publication of an article
From where data/document is obtainable
To the site of reputable domestic and foreign magazines
What processes are involved for a request to access data/document
It depends on the acceptance and publication of the article in the intended journal