History
# Registration date Revision Id
3 2017-12-03, 1396/09/12 36116
2 2016-12-29, 1395/10/09 23417
1
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  • Protocol summary

    This is a randomized, double-blind clinical trial with the aim to study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Functional dyspepsia. Study population is the patients that referred to gastroenterology clinic and sample size for study is 50 person. The inclusion criteria are written consent, complete knowledge about the study and being diagnosed with Irritable bowel syndrome based on the ROME III criteria. The exclusion criteria are the participants’ lack of consent to continue their participation in the study, warning symptoms and signs of gastric and intestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease, also, kidney or liver diseases based on patient history, physical examination and medical records. The study will last for 14 days, and the participants will be randomly divided into two groups; namely, the intervention group (receiving capsules containing the essential oil of the plant), and the control group (receiving hyoscine 20 mg tablet three times a day for 2 weeks). Moreover, patient characteristics such as severity of disease symptoms, and quality of life will enter into a form ( prepared in advance) at the beginning, at the end, and two weeks after completion of treatment in order to assess treatment outcome. After completion of the treatment, the safety of the treatment regimen will also be assessed by doing laboratory tests and through recording adverse drug reactions.
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    مطالعه‌ی حاضر به صورت کارآزمایی بالینی دو سوکور با هدف بررسی میزان اثربخشی داروی گیاهی حاوی اسانس آویشن شیرازی، زنیان و شوید در بهبود سندرم روده تحریک پذیر میباشد. جمعیت مورد مطالعه بیمارن مراجعه کننده به درمانگاه گوارش و حجم نمونه مورد مطالعه 50 نفر می باشد. معیار ورود به مطالعه رضایت کتبی و آگاهی کامل از مطالعه و شناخته شدن به عنوان مورد سندرم روده تحریک پذیر بر اساس معیار Rome III می باشد،معیار خروج از مطالعه عدم رضایت اشخاص به ادامه همکاری در مطالعه، وجود علائم خطر به نفع بدخیمی معده و روده، سایر بیماری های مزمن گوارشی و زخم پپتیک و همچنین بیماری کلیوی و کبدی بر اساس شرح حال، معاینه و سوابق پزشکی بیمار میباشد. مدت مطالعه 14 روز خواهد بود، و افراد به صورت تصادفی در یکی از دو گروه : مداخله (دریافت کپسول حاوی اسانس گیاهی) و کنترل (دریافت قرص هیوسین) قرار خواهند گرفت. همچنین اطلاعات بیماران از جمله شدت علائم بیماری و کیفیت زندگی بیماران نیز جهت ارزیابی پیامد درمان در ابتدای دوره درمانی، انتهای دوره درمانی و 2 هفته پس از اتمام دوره درمان در یک فرم از پیش تهیه شده وارد خواهد شد. ارزیابی ایمنی رژیم درمانی نیز با انجام تست های آزمایشگاهی پس از اتمام دوره درمان و با ثبت عوارض دارویی انجام خواهد شد.
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    Study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of irritable bowel syndrome.
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    بررسی میزان اثربخشی داروی گیاهی حاوی اسانس آویشن شیرازی، زنیان و شوید در بهبود سندرم روده تحریک پذیر.
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    Study population is the patients that referred to gastroenterology clinic and sample size for study is 60 person. patients are divided into two control and intervention groups by simple randomization and using the Random Allocation software.
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    جمعیت مورد مطالعه، بیمارن مراجعه کننده به درمانگاه گوارش و حجم نمونه 60 نفر میباشد. بیماران به روش تصادفی ساده و با استفاده از نرم افزار Random Allocation به دو گروه مداخله و کنترل تقسیم میشوند.
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    This is a randomized, double-blind clinical trial that is done in gastrointestinal clinic of Shahid Mohammadi Hospial in Bandar Abbas city. In this study, blind persons are participants, clinical caregiver and responsible individual for evaluating the outcome of treatment.
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    مطالعه‌ی حاضر به صورت کارآزمایی بالینی دو سوکور و در درمانگاه گوارش بیمارستان شهید محمدی شهر بندر عباس انجام میشود. در این مطالعه شرکت کنندگان، مراقب بالینی و فرد مسئول ارزیابی پیامد درمان کور میباشند.
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    The inclusion criteria are written consent, complete knowledge about the study and being diagnosed with Irritable bowel syndrome based on the ROME III criteria. The exclusion criteria are the lack of consent to continue their participation, kidney or liver diseases, warning symptoms of gastrointestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease based on patient history, physical examination and medical records.
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    معیار ورود به مطالعه رضایت کتبی و آگاهی کامل از مطالعه و شناخته شدن به عنوان مورد سندرم روده تحریک پذیر بر اساس معیار Rome III می باشد. معیار خروج از مطالعه عدم رضایت اشخاص به ادامه همکاری ، وجود بیماری کلیوی و کبدی، وجود علائم خطر به نفع بدخیمی معده و روده، سایر بیماری های مزمن گوارشی و زخم پپتیک بر اساس شرح حال، معاینه و سوابق پزشکی بیمار میباشد.
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    The study will last for 14 days, the patients of intervention group are received capsules containing the essential oil of the plant twice times a day, and the control group are received Hyoscine tablet three times a day.
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    مدت مطالعه 14 روز خواهد بود. بیماران گروه مداخله روزانه دو کپسول حاوی اسانس گیاهی و بیماران گروه کنترل روزانه سه قرص هیوسین دریافت میکنند.
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    Patient characteristics such as severity of disease symptoms, and quality of life will enter into a form at the beginning, at the end, and two weeks after completion of treatment. After completion of the treatment, the safety of the treatment regimen will also be assessed by laboratory tests and through recording adverse drug reactions.
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    اطلاعات بیماران از جمله شدت علائم بیماری و کیفیت زندگی جهت ارزیابی پیامد درمان در ابتدای دوره درمانی، انتهای دوره درمانی و 2 هفته پس از اتمام دوره درمان در یک فرم وارد خواهد شد. ارزیابی ایمنی رژیم درمانی با تست های آزمایشگاهی پس از اتمام دوره درمان و با ثبت عوارض دارویی انجام میشود.
  • General information

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    15
    50
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    Year
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    No
    Yes
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    1
    1
    Used
    Not used
    2
    2-3
    50
    60
    2017-01-14, 1395/10/25
    2017-09-16, 1396/06/25
    Written consent and complete knowledge about the study.
    Being diagnosed with Irritable bowel syndrome based on the ROME III criteria.
    رضایت کتبی و آگاهی کامل از مطالعه.
    شناخته شدن به عنوان مورد سندرم روده تحریک پذیر بر اساس معیار Rome III.
    The participants’ lack of consent to continue their participation in the study.
    Kidney and liver diseases based on laboratory tests.
    Warning symptoms of gastric and intestinal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination and medical records.
    عدم رضایت اشخاص به ادامه همکاری در مطالعه.
    بیماری کلیوی و کبدی بر اساس تست های آزمایشگاهی.
    وجود علائم خطر به نفع بدخیمی معده و روده، سایر بیماری های مزمن گوارشی و زخم پپتیک بر اساس شرح حال، معاینه و سوابق پزشکی بیمار.
    The randomization method in this study will be simple randomization and by using the random number table.
    روش تصادفی سازی در این مطالعه روش تصادفی ساده و با استفاده از جدول اعداد تصادفی میباشد.
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    simple randomization method and using the Random Allocation software.
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    روش تصادفی ساده و با استفاده از نرم افزار Random Allocation.
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    After the patient is visited and proved by gastroenterologist to have required conditions ,the informed consent is obtained from the patients and they will be referred to GP to receive the drug. By simple randomization method and using the random Allocation, GP puts the patients in two equal group of control and interference.The patients in the control group receive medicinal regimen of type A and the patients in the interference group receive the medicinal regimen of type B. The drugs are placed in the containers with the same shape and appearance with code of A and B on them by the way the patients are uninformed about the regimen type. Finally the assessment is done by a third individual (a trained medical student) that is uninformed about the type of regimen A and B.
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    بعد از ویزیت بیماران توسط متخصص گوارش و وجود شرایط ورود به مطالعه، توضیحات لازم در مورد مطالعه به بیمار داده شده و پس از جلب رضایت آگاهانه، بیمار به پزشک عمومی در اتاق دیگری جهت تجویز دارو ارجاع داده خواهد شد. پزشک عمومی بیمارن را به روش تصادفی ساده تصادفی و با استفاده از نرم افزار random Allocation در 2 گروه مساوی کنترل و مداخله قرار داده و به گروه کنترل رژیم دارویی A و به گروه مداخله رژیم دارویی B خواهد داد. دارو ها در ظرف های یک شکل با کد A یا B قرار داده شده و بیماران از نوع رژیم درمانی بی اطلاع میباشند. در نهایت ارزیابی درمان از جمله ثبت علائم بالینی توسط فرد سومی که از نوع رژیم های A و B بی اطلاع بود انجام میپذیرد.
  • Primary outcomes

    #1
    کیفیت زندگی افراد
    کیفیت زندگی
    Before intervention, end of intervention, 2 weeks after intervention
    Before intervention, end of intervention and 2 weeks after intervention
    ابتدا و اتنهای و 2 هفته پس از اتمام دوره درمان
    ابتدا، انتها و 2 هفته پس از اتمام دوره درمان
    (IBS-QOL)
    IBS Quality of life(IBS-QOL)
    پرسشنامه کیفیت زندگی بیماران(IBS-QOL)
    پرسشنامه کیفیت زندگی بیماران سندرم روده تحریک پذیر
    #2
    end of intervention, 2 weeks after intervention
    End of intervention and 2 weeks after intervention
    اتنهای و 2 هفته پس از اتمام دوره درمان
    انتها و 2 هفته پس از اتمام دوره درمان
    IBS Adequate relief(IBS-AR
    IBS Adequate relief(IBS-AR)
    #3
    end of intervention, 2 weeks after intervention
    End of intervention and 2 weeks after intervention
    اتنهای و 2 هفته پس از اتمام دوره درمان
    انتها و 2 هفته پس از اتمام دوره درمان
    #4
    average score of Irritable bowel syndrom
    Average score of IBS Symptom Severity Scale(IBS-SSS)
    Before intervention, end of intervention, 2 weeks after intervention
    Before intervention, end of intervention and 2 weeks after intervention
    ابتدا و اتنهای و 2 هفته پس از اتمام دوره درمان
    ابتدا، انتها و 2 هفته پس از اتمام دوره درمان
    (IBS-SSS)IBS Symptom Severity Scale
    IBS Symptom Severity Scale(IBS-SSS)
    مقایس شدت علائم گوارشی بیماران سندرم روده تحریک پذیر(IBS-SSS)
    مقایس شدت علائم گوارشی بیماران سندرم روده تحریک پذیر
  • Secondary outcomes

    #1
    after intervention
    After intervention
    با بررسی میزان داروی باقی مانده دز انتهای دوره درمانی
    با بررسی میزان داروی باقی مانده در انتهای دوره درمانی
    #2
    Elevation of liver enzymes
    Liver enzymes disorder
    افزایش آنزیم های کبدی
    اختلال آنزیم های کبدی
    after intervention
    Before and after intervention
    بعد از اتمام دوره درمان
    ابتدا و بعد از اتمام دوره درمان
    labratory test(AST,ALT,ALP,Billi T,D)
    Labratory test(AST,ALT,ALP,Billi T,D)
    #3
    Dysfunction of kidney
    Renal dysfunction
    اختلال در عملکرد کلیوی
    اختلال عملکرد کلیوی
    after intervention
    Before and after intervention
    بعد از اتمام دوره درمان
    ابتدا و بعد از اتمام دوره درمان
    labratory tests (BUN,Cr)
    Labratory test(BUN,Cr)
    #4
    Entry the side effects by patient and Responsible for study in side effects form
    Entry the side effects by patient and clinical caregiver in side effects form
    ثبت عوارض توسط فرد و مسئول مطالعه در فرم عوارض دارویی
    ثبت عوارض توسط بیمار و مراقب بالینی در فرم عوارض دارویی
  • Intervention groups

    #1
    Intervention group: Prescription of edible capsule containing 60mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 4 times a day for 2 weeks.
    ntervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks.
    گروه مداخله: تجویز کپسول خوراکی حاوی 60 میلیگرم اسانس میوه گیاه زنیان، گیاه آویشن شیرازی و بذز شوید ، 4 بار در روز به مدت 2 هفته.
    گروه مداخله: تجویز کپسول خوراکی حاوی 180 میلیگرم اسانس میوه زنیان، آویشن شیرازی و شوید ، 2 بار در روز به مدت 2 هفته.
    #2
    Control group: Prescription of hyoscine 20 mg tablet three times a day for 2 weeks.
    Control group: Prescription of hyoscine 10 mg tablet three times a day for 2 weeks.
    گروه کنترل: تجویز 20 میلیگرم قرص هیوسن 3 باز در روز به مدت 2 هفته.
    گروه کنترل: تجویز 10 میلیگرم قرص هیوسن 3 باز در روز به مدت 2 هفته.
  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Mohamadi hospital
    Name of recruitment center - Persian: بیمارستان شهید محمدی
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Street address - English: Shahid Mohamadi hospital, Bandar abbas, Hormozgan, Iran
    Street address - Persian: ایران، هرمزگان، بندر عباس، بیمارستان شهید محمدی
    City - English: Bandar abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Shahid Mohamadi hospital
    Name of recruitment center - Persian: بیمارستان شهید محمدی
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Street address - English: Shahid Mohamadi hospital, Bandar abbas, Hormozgan, Iran
    Street address - Persian: ایران، هرمزگان، بندر عباس، بیمارستان شهید محمدی
    City - English: Bandar abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Fax:
    Email: research@hums.ac.ir
    Web page address: http://www.resv.hums.ac.ir/
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Hormozgan Science & Technology Park
    Name of organization / entity - Persian: پارک علم و فناوری هرمزگان
    Full name of responsible person - English: Majid Sarnay zade
    Full name of responsible person - Persian: مجید سرنی زاده
    Street address - English: Health Technology Incubation Center, Azadegan, Bandar Abbas, Iran.
    Street address - Persian: بندر عباس، آزادگان، مرکز رشد فناوری سلامت
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Hormozgan Science & Technology Park
    Name of organization / entity - Persian: پارک علم و فناوری هرمزگان
    Full name of responsible person - English: Majid Sarnay zade
    Full name of responsible person - Persian: مجید سرنی زاده
    Street address - English: Health Technology Incubation Center, Azadegan, Bandar Abbas, Iran.
    Street address - Persian: بندر عباس، آزادگان، مرکز رشد فناوری سلامت
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: ۷۹۱۴۹۵۴۵۶۱
    Phone: +98 76 3333 4016
    Fax:
    Email: incubator.hmstp@gmail.com
    Web page address:
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    Other
    #2
    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Majid Sarnay zade
    Full name of responsible person - Persian: مجید سرنی زاده
    Street address - English: Vice Chancellor for research of Hormozgan University of Medical Sciences, Shahid Mohamadi hospital,Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی دانشگاه علوم پزشکی هرمزگان
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Majid Sarnay zade
    Full name of responsible person - Persian: مجید سرنی زاده
    Street address - English: Vice Chancellor for research of Hormozgan University of Medical Sciences, Shahid Mohamadi hospital,Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی دانشگاه علوم پزشکی هرمزگان
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Fax:
    Email: research@hums.ac.ir
    Web page address: http://www.resv.hums.ac.ir/
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Iran.
    Street address - Persian: بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی، کمیته تحقیقات دانشجویی
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: bordbarghasem1@yahoo.com.ghasem.bordbar@hums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Iran.
    Street address - Persian: بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی، کمیته تحقیقات دانشجویی
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: ghasem.bordbar@hums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Student research comitte, Vice-chancellery for research, Hormozgan University of Medical Siences.
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان، معاونت پژوهشی، کمیته تحقیقات دانشجویی
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی،کمیته تحقیقات دانشجویی.
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: bordbarghasem1@yahoo.com.ghasem.bordbar@hums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Student research comitte, Vice-chancellery for research, Hormozgan University of Medical Siences.
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان، معاونت پژوهشی، کمیته تحقیقات دانشجویی
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی،کمیته تحقیقات دانشجویی.
    City - English: Bandar Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: ghasem.bordbar@hums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Student research comitte, Vice-chancellery for research, Hormozgan university of Medical Science.
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان، معاونت پژوهشی، کمیته تحقیقات دانشجویی.
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی،کمیته تحقیقات دانشجویی.
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: bordbarghasem1@yahoo.com.ghasem.bordbar@hums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Student research comitte, Vice-chancellery for research, Hormozgan university of Medical Science.
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان، معاونت پژوهشی، کمیته تحقیقات دانشجویی.
    Full name of responsible person - English: Ghasem Bordbar
    Full name of responsible person - Persian: قاسم بردبار
    Position - English: Medical student
    Position - Persian: دانشجوی پزشکی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، معاونت پژوهشی،کمیته تحقیقات دانشجویی.
    City - English: Bandar Abbas
    City - Persian: بندر عباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7915915517
    Phone: +98 76 3333 7192
    Mobile: +98 939 491 6962
    Fax: +98 76 3333 7192
    Email: ghasem.bordbar@hums.ac.ir
    Web page address:
  • Sharing plan

    no
    no
    no
    no
    no
    no
    no
    empty
    According to the subject of the study, which is about an invention. To prevent misuse of the details of the study information, there is currently no way to publish information.
    empty
    با توجه به موضوع مطالعه که پیرامون یک اختراع میباشد. جهت جلوگیری از سوءاستفاده از جزییات اطلاعات مطالعهٰٰٰ، در حال حاضر امکان انتشار اطلاعات وجود ندارد.

Protocol summary

Study aim
Study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of irritable bowel syndrome.
Design
Study population is the patients that referred to gastroenterology clinic and sample size for study is 60 person. patients are divided into two control and intervention groups by simple randomization and using the Random Allocation software.
Settings and conduct
This is a randomized, double-blind clinical trial that is done in gastrointestinal clinic of Shahid Mohammadi Hospial in Bandar Abbas city. In this study, blind persons are participants, clinical caregiver and responsible individual for evaluating the outcome of treatment.
Participants/Inclusion and exclusion criteria
The inclusion criteria are written consent, complete knowledge about the study and being diagnosed with Irritable bowel syndrome based on the ROME III criteria. The exclusion criteria are the lack of consent to continue their participation, kidney or liver diseases, warning symptoms of gastrointestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease based on patient history, physical examination and medical records.
Intervention groups
The study will last for 14 days, the patients of intervention group are received capsules containing the essential oil of the plant twice times a day, and the control group are received Hyoscine tablet three times a day.
Main outcome variables
Patient characteristics such as severity of disease symptoms, and quality of life will enter into a form at the beginning, at the end, and two weeks after completion of treatment. After completion of the treatment, the safety of the treatment regimen will also be assessed by laboratory tests and through recording adverse drug reactions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016072629026N3
Registration date: 2016-12-29, 1395/10/09
Registration timing: registered_while_recruiting

Last update: 2018-02-06, 1396/11/17
Update count: 1
Registration date
2016-12-29, 1395/10/09
Registrant information
Name
Ghasem Bordbar
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
ghasem.bordbar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences.Hormozgan Science & Technology Park.
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2017-09-16, 1396/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Irritable bowel syndrome (IBS).
Public title
Herbal drug for treatment of Irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent and complete knowledge about the study. Being diagnosed with Irritable bowel syndrome based on the ROME III criteria.
Exclusion criteria:
The participants’ lack of consent to continue their participation in the study. Kidney and liver diseases based on laboratory tests. Warning symptoms of gastric and intestinal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination and medical records.
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization method and using the Random Allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the patient is visited and proved by gastroenterologist to have required conditions ,the informed consent is obtained from the patients and they will be referred to GP to receive the drug. By simple randomization method and using the random Allocation, GP puts the patients in two equal group of control and interference.The patients in the control group receive medicinal regimen of type A and the patients in the interference group receive the medicinal regimen of type B. The drugs are placed in the containers with the same shape and appearance with code of A and B on them by the way the patients are uninformed about the regimen type. Finally the assessment is done by a third individual (a trained medical student) that is uninformed about the type of regimen A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellery for research of Hormozgan University of Medical Science.
Street address
Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
HUMS.REC.1394.012

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Quality of life
Timepoint
Before intervention, end of intervention and 2 weeks after intervention
Method of measurement
IBS Quality of life(IBS-QOL)

2

Description
Relife of symptoms
Timepoint
End of intervention and 2 weeks after intervention
Method of measurement
IBS Adequate relief (IBS-AR)

3

Description
Relife of symptoms
Timepoint
End of intervention and 2 weeks after intervention
Method of measurement
IBS Global Assessment improvement(IBS-GAI)

4

Description
Average score of IBS Symptom Severity Scale(IBS-SSS)
Timepoint
Before intervention, end of intervention and 2 weeks after intervention
Method of measurement
IBS Symptom Severity Scale(IBS-SSS)

Secondary outcomes

1

Description
Amount of drug consumption
Timepoint
After intervention
Method of measurement
By checking the residual amount of drug after intervention

2

Description
Liver enzymes disorder
Timepoint
Before and after intervention
Method of measurement
Labratory test(AST,ALT,ALP,Billi T,D)

3

Description
Renal dysfunction
Timepoint
Before and after intervention
Method of measurement
Labratory test(BUN,Cr)

4

Description
Drug side effects
Timepoint
During and after intervention
Method of measurement
Entry the side effects by patient and clinical caregiver in side effects form

Intervention groups

1

Description
ntervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: Prescription of hyoscine 10 mg tablet three times a day for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohamadi hospital
Full name of responsible person
Ghasem Bordbar
Street address
Shahid Mohamadi hospital, Bandar abbas, Hormozgan, Iran
City
Bandar abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
http://www.resv.hums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hormozgan Science & Technology Park
Full name of responsible person
Majid Sarnay zade
Street address
Health Technology Incubation Center, Azadegan, Bandar Abbas, Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
۷۹۱۴۹۵۴۵۶۱
Phone
+98 76 3333 4016
Email
incubator.hmstp@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan Science & Technology Park
Proportion provided by this source
80
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
Other

2

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Majid Sarnay zade
Street address
Vice Chancellor for research of Hormozgan University of Medical Sciences, Shahid Mohamadi hospital,Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Web page address
http://www.resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences
Proportion provided by this source
20
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
Hormozgan University of Medical Science
Full name of responsible person
Ghasem Bordbar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
ghasem.bordbar@hums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Student research comitte, Vice-chancellery for research, Hormozgan University of Medical Siences.
Full name of responsible person
Ghasem Bordbar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
ghasem.bordbar@hums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student research comitte, Vice-chancellery for research, Hormozgan university of Medical Science.
Full name of responsible person
Ghasem Bordbar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915915517
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
ghasem.bordbar@hums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the subject of the study, which is about an invention. To prevent misuse of the details of the study information, there is currently no way to publish information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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