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Protocol summary
Objective: Determine the efficacy of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma.
Design study: non-randomized, not-blind, non- placebo controlled, multi center, Phase 2 clinical trial
The method of study:
Inclusion criteria: Resistant to treat Asthma in step 4, Dry cough.
Exclusion criteria: Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation, Concurrent use of other immunosuppressive drugs
Target sample size: 25
Interventions: Diagnostic spirometry before and after treatment, Treatment with therapeutic package containing plantain seed and Almond gum.
Time of intervention: 6 weeks.
Outcomes: Reduce or improve in Asthma symptoms regarding spirometry, Asthma control test, and Asthma quality of life questionnaires.
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Objective: Determine the efficacy of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma. Design study: non-randomized, not-blind, non- placebo controlled, multi center, Phase 2 clinical trial The method of study: Inclusion criteria: Resistant to treat Asthma in step 4, Dry cough. Exclusion criteria: Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation, Concurrent use of other immunosuppressive drugs Target sample size: 25 Interventions: Diagnostic spirometry before and after treatment, Treatment with therapeutic package containing plantain seed and Almond gum. Time of intervention: 6 weeks. Outcomes: Reduce or improve in Asthma symptoms regarding spirometry, Asthma control test, and Asthma quality of life questionnaires.
هدف: تعیین اثر بخشی فرآورده ترکیبی از گیاه بارهنگ و صمغ بادام بر علائم بالینی و آزمونهای عملکرد ریوی در بیماران مبتلا به آسم مقاوم به درمان، طراحی انجام مطالعه: غیرتصادفی، کور نشده، بدون کنترل و دارونما، چند مرکزی، مرحله دو کارآزمایی.
روش انجام مطالعه شامل:الف) معیارهای اصلی ورود به مطالعه: بيماران با آسم مقاوم به درمان در مرحله ۴، سرفه های خشک، ب) معیارهای اصلی خروج از مطالعه: آسم ناپایدار،عفونتهای تنفسی حاد، بیماریهای انسدادی روده، بارداری و شیردهی، همزمانی مصرف سایر داروهای ایمنوساپرسیو، ج) حجم نمونه: 25 نفر، د) مداخله یا مداخلات مورد مطالعه: انجام اسپیرومتری تشخیصی قبل و بعد از درمان، درمان دارویی با بسته درمانی حاوی بذر بارهنگ و صمغ بادام، زمان مداخله: 6 هفته، و) پیامد اولیه یا پیامدهای مورد مطالعه: کاهش یا بهبود علایم بیماری بر اساس معیارهای اسپیرومتری، پرسشنامه کنترل آسم و پرسشنامه کیفیت زندگی در آسم.
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هدف: تعیین اثر بخشی فرآورده ترکیبی از گیاه بارهنگ و صمغ بادام بر علائم بالینی و آزمونهای عملکرد ریوی در بیماران مبتلا به آسم مقاوم به درمان، طراحی انجام مطالعه: غیرتصادفی، کور نشده، بدون کنترل و دارونما، چند مرکزی، مرحله دو کارآزمایی. روش انجام مطالعه شامل:الف) معیارهای اصلی ورود به مطالعه: بيماران با آسم مقاوم به درمان در مرحله ۴، سرفه های خشک، ب) معیارهای اصلی خروج از مطالعه: آسم ناپایدار،عفونتهای تنفسی حاد، بیماریهای انسدادی روده، بارداری و شیردهی، همزمانی مصرف سایر داروهای ایمنوساپرسیو، ج) حجم نمونه: 25 نفر، د) مداخله یا مداخلات مورد مطالعه: انجام اسپیرومتری تشخیصی قبل و بعد از درمان، درمان دارویی با بسته درمانی حاوی بذر بارهنگ و صمغ بادام، زمان مداخله: 6 هفته، و) پیامد اولیه یا پیامدهای مورد مطالعه: کاهش یا بهبود علایم بیماری بر اساس معیارهای اسپیرومتری، پرسشنامه کنترل آسم و پرسشنامه کیفیت زندگی در آسم.
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Determine the effect of adding herbal compound based on Plantago major and almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
Determine the effect of adding herbal compound based on Plantago major and almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
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بررسی اثر افزودن فرآورده ترکیبی بر پایه گیاه بارهنگ و صمغ بادام به درمانهای رایج مبتلایان به آسم مقاوم به درمانهای رایج برعلایم بالینی و آزمونهای تنفسی بیماران
بررسی اثر افزودن فرآورده ترکیبی بر پایه گیاه بارهنگ و صمغ بادام به درمانهای رایج مبتلایان به آسم مقاوم به درمانهای رایج برعلایم بالینی و آزمونهای تنفسی بیماران
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In this study, 25 patients with resistant asthma who have inclusion criteria will be admitted to the Ghaem hospital and private clinics will be selected. It is a non-randomized, not-blind, nonplacebo-controlled, multicenter, Phase 2 clinical trial
In this study, 25 patients with resistant asthma who have inclusion criteria will be admitted to the Ghaem hospital and private clinics will be selected. It is a non-randomized, not-blind, nonplacebo-controlled, multicenter, Phase 2 clinical trial
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در این مطالعه 25 بیمار مبتلا به آسم مقاوم و دارای شرایط ورود به مطالعه که به بیمارستان قایم و مطب های خصوصی مراجعه می کنند انتخاب خواهند شد. مطالعه غیرتصادفی، کور نشده، بدون کنترل و دارونما، چند مرکزی، مرحله دو کارآزمایی.
در این مطالعه 25 بیمار مبتلا به آسم مقاوم و دارای شرایط ورود به مطالعه که به بیمارستان قایم و مطب های خصوصی مراجعه می کنند انتخاب خواهند شد. مطالعه غیرتصادفی، کور نشده، بدون کنترل و دارونما، چند مرکزی، مرحله دو کارآزمایی.
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The study is conducted in Ghaem hospital in Mashhad and private clinics and will not have blinding
The study is conducted in Ghaem hospital in Mashhad and private clinics and will not have blinding
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مطالعه در بیمارستان قایم مشهد و مطب های خصوصی انجام می شود و کورسازی نخواهد داشت
مطالعه در بیمارستان قایم مشهد و مطب های خصوصی انجام می شود و کورسازی نخواهد داشت
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Inclusion criteria is Resistant to treat Asthma in step 4 with A dry cough;
Exclusion criteria are patients with Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation and Concurrent use of other immunosuppressive drugs
Inclusion criteria is Resistant to treat Asthma in step 4 with A dry cough; Exclusion criteria are patients with Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation and Concurrent use of other immunosuppressive drugs
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شرایط ورود به مطالعه بيماران با آسم مقاوم به درمان در مرحله 4 و دارای سرفه های خشک می باشد; شرایط عدم ورود به مطالعه شامل آسم ناپایدار،عفونتهای تنفسی حاد، بیماریهای انسدادی روده، بارداری و شیردهی و همزمانی مصرف سایر داروهای ایمنوساپرسیو می باشد
شرایط ورود به مطالعه بيماران با آسم مقاوم به درمان در مرحله 4 و دارای سرفه های خشک می باشد; شرایط عدم ورود به مطالعه شامل آسم ناپایدار،عفونتهای تنفسی حاد، بیماریهای انسدادی روده، بارداری و شیردهی و همزمانی مصرف سایر داروهای ایمنوساپرسیو می باشد
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Intervention is treatment with a therapeutic package containing plantain seed and Almond gum.
Time of intervention is 4 weeks.
Intervention is treatment with a therapeutic package containing plantain seed and Almond gum. Time of intervention is 4 weeks.
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مداخله مورد مطالعه شامل درمان دارویی با بسته درمانی حاوی بذر بارهنگ و صمغ بادام، و زمان مداخله 4 هفته می باشد
مداخله مورد مطالعه شامل درمان دارویی با بسته درمانی حاوی بذر بارهنگ و صمغ بادام، و زمان مداخله 4 هفته می باشد
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The study outcomes are reduction or improvement in Asthma symptoms regarding spirometry parameters, Asthma control test, and Asthma quality of life questionnaires.
The study outcomes are reduction or improvement in Asthma symptoms regarding spirometry parameters, Asthma control test, and Asthma quality of life questionnaires.
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پیامدهای مورد مطالعه شامل کاهش یا بهبود علایم بیماری بر اساس معیارهای اسپیرومتری، پرسشنامه کنترل آسم و پرسشنامه کیفیت زندگی در آسم.
پیامدهای مورد مطالعه شامل کاهش یا بهبود علایم بیماری بر اساس معیارهای اسپیرومتری، پرسشنامه کنترل آسم و پرسشنامه کیفیت زندگی در آسم.
General information
Patients with resistant to treat asthma who had often dry cough in their history
Patients with resistant to treat asthma who had often dry cough in their history
کلیه بیماران مبتلا به آسم مقام به درمان که غالبا دارای سرفه های خشک در شرح حال بودند
کلیه بیماران مبتلا به آسم مقام به درمان که غالبا دارای سرفه های خشک در شرح حال بودند
Primary outcomes
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Before and six weeks after intervention
Before and four weeks after intervention
Before and sixfour weeks after intervention
قبل از مداخله و شش هفته بعد از مداخله
قبل از مداخله و چهار هفته بعد از مداخله
قبل از مداخله و ششچهار هفته بعد از مداخله
Secondary outcomes
#1
Before and 6 weeks after intervention
Before and 4 weeks after intervention
Before and 64 weeks after intervention
قبل از مداخله و 6 هفته پس از شروع مداخله
قبل از مداخله و 4 هفته پس از شروع مداخله
قبل از مداخله و 64 هفته پس از شروع مداخله
Intervention groups
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Intervention group: Oral drug:Powder of almond gum and plantago major seeds;
Dose: 5 grams of pack contains 3 grams of almond gum powder and 2 grams of plantago major seed, every 8 hours, the duration of treatment (consumption): 6 weeks; How to use: Patients should dissolve the content of each pack in 150 cc warm water and consume it after 30 minute by maintaining an hour away from food.
Intervention group: Oral drug:Powder of almond gum and Plantago major seeds; Dose: 5 grams of the pack contains 3 grams of almond gum powder and 2 grams of Plantago major seed, every 8 hours, the duration of treatment (consumption): 4 weeks; How to use: Patients should dissolve the content of each pack in 150 ccs warm water and consume it after 30 minutes by maintaining an hour away from food.
Intervention group: Oral drug:Powder of almond gum and plantagoPlantago major seeds; Dose: 5 grams of the pack contains 3 grams of almond gum powder and 2 grams of plantagoPlantago major seed, every 8 hours, the duration of treatment (consumption): 64 weeks; How to use: Patients should dissolve the content of each pack in 150 ccccs warm water and consume it after 30 minuteminutes by maintaining an hour away from food.
گروه مداخله: داروی خوراکی: پودر حاصل از صمغ بادام به همرا بذر بارهنگ دوز مصرفي: 5 گرم حاوی 3 گرم پودر صمغ بادام و 2 گرم بذر بارهنگ، هر 8 ساعت، مدت زمان مداخله (دوره مصرف): 6 هفته؛ نحوه مصرف: بیمار باید محتویات هر بسته رادر ۱۵۰ سیسی آبجوش ولرم حل نماید و بعد از گذشت ۳۰ دقیقه با حفظ فاصله یکساعته از غذا مصرف نمایند
گروه مداخله: داروی خوراکی: پودر حاصل از صمغ بادام به همرا بذر بارهنگ دوز مصرفي: 5 گرم حاوی 3 گرم پودر صمغ بادام و 2 گرم بذر بارهنگ، هر 8 ساعت، مدت زمان مداخله (دوره مصرف): 4 هفته؛ نحوه مصرف: بیمار باید محتویات هر بسته رادر ۱۵۰ سیسی آبجوش ولرم حل نماید و بعد از گذشت ۳۰ دقیقه با حفظ فاصله یکساعته از غذا مصرف نمایند
گروه مداخله: داروی خوراکی: پودر حاصل از صمغ بادام به همرا بذر بارهنگ دوز مصرفي: 5 گرم حاوی 3 گرم پودر صمغ بادام و 2 گرم بذر بارهنگ، هر 8 ساعت، مدت زمان مداخله (دوره مصرف): 64 هفته؛ نحوه مصرف: بیمار باید محتویات هر بسته رادر ۱۵۰ سیسی آبجوش ولرم حل نماید و بعد از گذشت ۳۰ دقیقه با حفظ فاصله یکساعته از غذا مصرف نمایند
Recruitment centers
#1
Name of recruitment center - English: Ghaem Clinic
Name of recruitment center - Persian: کلینیک تخصصی قائم
Full name of responsible person - English: Dr Farahzad Jabbari Azad, Allergy and Clinical Immunologist, Associate Professor
Full name of responsible person - Persian: دکتر فرحزاد جباری آزاد،فوق تخصص آلرژی و ایمنولوژی بالینی، دانشیار دانشگاه
Street address - English: Special Clinic for Allergic diseases, Dr shariati Sq, Parastar St, Mashhad, Khorasan Razavi
Street address - Persian: مشهد، میدان دکتر شریعتی، خیابان پرستار، درمانگاه تخصصی آلرژی
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ghaem Clinic
Name of recruitment center - Persian: کلینیک تخصصی قائم
Full name of responsible person - English: Dr Farahzad Jabbari Azad, Allergy and Clinical Immunologist, Associate Professor
Full name of responsible person - Persian: دکتر فرحزاد جباری آزاد،فوق تخصص آلرژی و ایمنولوژی بالینی، دانشیار دانشگاه
Street address - English: Special Clinic for Allergic diseases, Dr shariati Sq, Parastar St, Mashhad, Khorasan Razavi
Street address - Persian: مشهد، میدان دکتر شریعتی، خیابان پرستار، درمانگاه تخصصی آلرژی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: +98 51 3840 0000
Fax:
Email: Quaem.Medical.Center@mums.ac.ir
Web page address:
Name of recruitment center - English: Ghaem Clinic Name of recruitment center - Persian: کلینیک تخصصی قائم Full name of responsible person - English: Dr Farahzad Jabbari Azad, Allergy and Clinical Immunologist, Associate Professor Full name of responsible person - Persian: دکتر فرحزاد جباری آزاد،فوق تخصص آلرژی و ایمنولوژی بالینی، دانشیار دانشگاه Street address - English: Special Clinic for Allergic diseases, Dr shariati Sq, Parastar St, Mashhad, Khorasan Razavi Street address - Persian: مشهد، میدان دکتر شریعتی، خیابان پرستار، درمانگاه تخصصی آلرژی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176699199 Phone: +98 51 3840 0000 Fax: Email: Quaem.Medical.Center@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه
Full name of responsible person - English: Dr. Mohsen Tafaghodi, Research Vice Chancellor
Full name of responsible person - Persian: دکتر محسن تفقدی، معاون پژوهش و فناوری دانشگاه علوم پزشکی مشهد
Street address - English: Vice Chancellery for Research of Mashhad University of Medical Sciences, Golestan Crossroad, Daneshgah Ave, Mashhad, Iran
Street address - Persian: خیابان دانشگاه، چهارراه گلستان، دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه مشهد
City - English: Mashhad
City - Persian: مشهد
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, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه
Full name of responsible person - English: Dr. Mohsen Tafaghodi, Research Vice Chancellor
Full name of responsible person - Persian: دکتر محسن تفقدی، معاون پژوهش و فناوری دانشگاه علوم پزشکی مشهد
Street address - English: Vice Chancellery for Research of Mashhad University of Medical Sciences, Golestan Crossroad, Daneshgah Ave, Mashhad, Iran
Street address - Persian: خیابان دانشگاه، چهارراه گلستان، دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 3007
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه Full name of responsible person - English: Dr. Mohsen Tafaghodi, Research Vice Chancellor Full name of responsible person - Persian: دکتر محسن تفقدی، معاون پژوهش و فناوری دانشگاه علوم پزشکی مشهد Street address - English: Vice Chancellery for Research of Mashhad University of Medical Sciences, Golestan Crossroad, Daneshgah Ave, Mashhad, Iran Street address - Persian: خیابان دانشگاه، چهارراه گلستان، دانشگاه علوم پزشکی مشهد، معاونت پژوهش و فناوری دانشگاه مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 3007 Fax: Email: vcresearch@mums.ac.ir Web page address:
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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: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi
Full name of responsible person - Persian: معصومه السادات کابلی فرشچی
Position - English: PhD Student of Traditional and Complementary Medicine
Position - Persian: دانشجوی دکترای طب سنتی و مکمل
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Six Jahad Ave, Mashhad Faculty of Traditional Medicine
Street address - Persian: خیابان جهاد، جهاد 6، دانشکده طب سنتی و مکمل مشهد
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3855 2188
Mobile: +98 915 522 7245
Fax:
Email: kabolifm911@mums.ac.ir
Web page address: www.mums.ac.ir
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi
Full name of responsible person - Persian: معصومه السادات کابلی فرشچی
Position - English: PhD Student of Traditional and Complementary Medicine
Position - Persian: دانشجوی دکترای طب سنتی و مکمل
Latest degree: med_doctor
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
Street address - Persian: میدان آزادی، دانشگاه علوم پزشکی مشهد، دانشکده طب ایرانی و مکمل
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3884 8931
Mobile: +98 915 522 7245
Fax:
Email: kabolifm911@mums.ac.ir
Web page address: http://tim.mums.ac.ir/
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi Full name of responsible person - Persian: معصومه السادات کابلی فرشچی Position - English: PhD Student of Traditional and Complementary Medicine Position - Persian: دانشجوی دکترای طب سنتی و مکمل Latest degree: med_doctor Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Six Jahad AveAzadi Square, Mashhad FacultyUniversity of TraditionalMedical Sciences, School of Persian and Complementary Medicine Street address - Persian: خیابان جهادمیدان آزادی، جهاد 6دانشگاه علوم پزشکی مشهد، دانشکده طب سنتیایرانی و مکمل مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3855 21883884 8931 Mobile: +98 915 522 7245 Fax: Email: kabolifm911@mums.ac.ir Web page address: www.mums.ac.ir http://tim.mums.ac.ir/
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Majid Anushiravani
Full name of responsible person - Persian: مجید انوشیروانی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 6 Jahad Ave, Mashhad Faculty of Traditional Medicine
Street address - Persian: خیابان جهاد، جهاد 6، دانشکده طب سنتی و مکمل مشهد
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 518552188
Mobile:
Fax:
Email: Anushiravanim@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Majid Anushiravani
Full name of responsible person - Persian: مجید انوشیروانی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
Street address - Persian: میدان آزادی، دانشگاه علوم پزشکی مشهد، دانشکده طب ایرانی و مکمل
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 518848931
Mobile: +98 915 321 8505
Fax:
Email: Anushiravanim@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Majid Anushiravani Full name of responsible person - Persian: مجید انوشیروانی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 058 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 6 Jahad AveAzadi Square, Mashhad FacultyUniversity of TraditionalMedical Sciences, School of Persian and Complementary Medicine Street address - Persian: خیابان جهادمیدان آزادی، جهاد 6دانشگاه علوم پزشکی مشهد، دانشکده طب سنتیایرانی و مکمل مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 518552188518848931 Mobile: +98 915 321 8505 Fax: Email: Anushiravanim@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi
Full name of responsible person - Persian: معصومه السادات کابلی فرشچی
Position - English: PhD Student of Traditional and Complementary Medicine
Position - Persian: دانشجوی دکترای طب سنتی و مکمل
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Six Jahad Ave, Mashhad Faculty of Traditional Medicine
Street address - Persian: خیابان جهاد، جهاد 6، دانشکده طب سنتی و مکمل مشهد
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9135913556
Phone: +98 51 3855 2188
Mobile: +98 915 522 7245
Fax: +98 51 3853 5980
Email: kabolifm911@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi
Full name of responsible person - Persian: معصومه السادات کابلی فرشچی
Position - English: PhD Student of Traditional and Complementary Medicine
Position - Persian: دانشجوی دکترای طب سنتی و مکمل
Latest degree: med_doctor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
Street address - Persian: میدان آزادی، دانشگاه علوم پزشکی مشهد، دانشکده طب ایرانی و مکمل
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3884 8931
Mobile: +98 915 522 7245
Fax:
Email: kabolifm911@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Masoumeh Sadat Kaboli Farshchi Full name of responsible person - Persian: معصومه السادات کابلی فرشچی Position - English: PhD Student of Traditional and Complementary Medicine Position - Persian: دانشجوی دکترای طب سنتی و مکمل Latest degree: med_doctor Area of specialty/work: 058 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Six Jahad AveAzadi Square, Mashhad FacultyUniversity of TraditionalMedical Sciences, School of Persian and Complementary Medicine Street address - Persian: خیابان جهادمیدان آزادی، جهاد 6دانشگاه علوم پزشکی مشهد، دانشکده طب سنتیایرانی و مکمل مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91359135569177948564 Phone: +98 51 3855 21883884 8931 Mobile: +98 915 522 7245 Fax: +98 51 3853 5980 Email: kabolifm911@mums.ac.ir Web page address:
Sharing plan
no
no
no
no
no
no
yes
yes
yes
yes
na
na
na
na
empty
Patients' information belongs to the project implementer and Mashhad University of Medical Sciences
Patients' information belongs to the project implementer and Mashhad University of Medical Sciences
empty
اطلاعات بیماران اختصاص به مجری طرح و دانشگاه علوم پزشکی مشهد دارد
اطلاعات بیماران اختصاص به مجری طرح و دانشگاه علوم پزشکی مشهد دارد
empty
The clinical study report will be shared in the form of a paper
The clinical study report will be shared in the form of a paper
empty
گزارش مطالعه بالینی در قالب مقاله به اشتراک قرار خواهد گرفت
گزارش مطالعه بالینی در قالب مقاله به اشتراک قرار خواهد گرفت
empty
The clinical study report will be available 6 months after the publication of the results
The clinical study report will be available 6 months after the publication of the results
empty
گزارش مطالعه بالینی بعد از 6 ماه از چاپ نتایج قابل دسترس خواهد بود
گزارش مطالعه بالینی بعد از 6 ماه از چاپ نتایج قابل دسترس خواهد بود
empty
Academic researchers
Academic researchers
empty
محققین دانشگاهی
محققین دانشگاهی
empty
It is possible to use the results of the study for other research projects in collaboration with the execution research project and Mashhad University of Medical Sciences
It is possible to use the results of the study for other research projects in collaboration with the execution research project and Mashhad University of Medical Sciences
empty
امکان استفاده از نتایج مطالعه جهت طرحهای تحقیاتی دیگرو با همکاری مجری طرح و دانشگاه علوم پزشکی مشهد وجود دارد.
امکان استفاده از نتایج مطالعه جهت طرحهای تحقیاتی دیگرو با همکاری مجری طرح و دانشگاه علوم پزشکی مشهد وجود دارد.
empty
Applicants can contact the execution research project for this purpose
Email address: Anushiravanim@mums.ac.ir
Contact number 00989153218505
Applicants can contact the execution research project for this purpose Email address: Anushiravanim@mums.ac.ir Contact number 00989153218505
empty
متقاضیان می توانند با مجری طرح تحقیقاتی بدین منظور تماس حاصل نمایند
Anushiravanim@mums.ac.ir
تلفن تماس : 00989153218505
متقاضیان می توانند با مجری طرح تحقیقاتی بدین منظور تماس حاصل نمایند Anushiravanim@mums.ac.ir تلفن تماس : 00989153218505
empty
The applicant can contact the execution research project 1 year after the publication of the results
The applicant can contact the execution research project 1 year after the publication of the results
empty
درخواست کننده بعد از گذشت 1سال از چاپ نتایج می تواند با مجری طرح تماس بگیرد
درخواست کننده بعد از گذشت 1سال از چاپ نتایج می تواند با مجری طرح تماس بگیرد
Protocol summary
Study aim
Determine the effect of adding herbal compound based on Plantago major and almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
Design
In this study, 25 patients with resistant asthma who have inclusion criteria will be admitted to the Ghaem hospital and private clinics will be selected. It is a non-randomized, not-blind, nonplacebo-controlled, multicenter, Phase 2 clinical trial
Settings and conduct
The study is conducted in Ghaem hospital in Mashhad and private clinics and will not have blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria is Resistant to treat Asthma in step 4 with A dry cough;
Exclusion criteria are patients with Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation and Concurrent use of other immunosuppressive drugs
Intervention groups
Intervention is treatment with a therapeutic package containing plantain seed and Almond gum.
Time of intervention is 4 weeks.
Main outcome variables
The study outcomes are reduction or improvement in Asthma symptoms regarding spirometry parameters, Asthma control test, and Asthma quality of life questionnaires.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2016012026117N1
Registration date:2017-01-31, 1395/11/12
Registration timing:prospective
Last update:2017-12-10, 1396/09/19
Update count:1
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Masoumeh Kaboli Farshchi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
kabolifm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ُStudy the effect of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
Public title
Effect of a herbal medicine combination in resistant to treat Asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with resistant to treat asthma who had often dry cough in their history
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Avenue, Central Building, Mashhad University of Medical Sciences, University Ethics Committee
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.MUMS.REC.1395.181
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma Allergic: bronchitis NOS rhinitis with asthma Atopic asthma Extrinsic allergic asthma Hay fever with asthma
Primary outcomes
1
Description
Asthma symptoms
Timepoint
Before and four weeks after intervention
Method of measurement
AQLQ and ACT Questionnaires
Secondary outcomes
1
Description
Airway obstruction
Timepoint
Before and 4 weeks after intervention
Method of measurement
Spirometry
Intervention groups
1
Description
Intervention group: Oral drug:Powder of almond gum and Plantago major seeds; Dose: 5 grams of the pack contains 3 grams of almond gum powder and 2 grams of Plantago major seed, every 8 hours, the duration of treatment (consumption): 4 weeks; How to use: Patients should dissolve the content of each pack in 150 ccs warm water and consume it after 30 minutes by maintaining an hour away from food.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Clinic
Full name of responsible person
Dr Farahzad Jabbari Azad, Allergy and Clinical Immunologist, Associate Professor
Street address
Special Clinic for Allergic diseases, Dr shariati Sq, Parastar St, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of Medical Sciences, Golestan Crossroad, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 3007
Email
vcresearch@mums.ac.ir
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, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Sadat Kaboli Farshchi
Position
PhD Student of Traditional and Complementary Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
Email
kabolifm911@mums.ac.ir
Web page address
http://tim.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Anushiravani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 518848931
Fax
Email
Anushiravanim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Sadat Kaboli Farshchi
Position
PhD Student of Traditional and Complementary Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Mashhad University of Medical Sciences, School of Persian and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
Email
kabolifm911@mums.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
Patients' information belongs to the project implementer and Mashhad University of Medical Sciences
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
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
The clinical study report will be shared in the form of a paper
When the data will become available and for how long
The clinical study report will be available 6 months after the publication of the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
It is possible to use the results of the study for other research projects in collaboration with the execution research project and Mashhad University of Medical Sciences
From where data/document is obtainable
Applicants can contact the execution research project for this purpose
Email address: Anushiravanim@mums.ac.ir
Contact number 00989153218505
What processes are involved for a request to access data/document
The applicant can contact the execution research project 1 year after the publication of the results