Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Background and the Purpose of the Study: stomatitis is a disturbing and prevalent side-effect of chemotherapy that disturbs patients and causes difficulties in patient’s drinking, eating and talking, and may results in infection and bleeding and eventually decrease quality of life .This study aimed to investigate the effect of the marshmallow root extract on treatment of Stomatitis due chemotherapy. Materials and Methods: This randomized controlled trial study was conducted during 2016.The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran. In this study, 50 patients diagnosed with cancer that undergoing chemoterapy were randomly assigned into control and experimental groups in similar blocks according to their stomatitis severity. In this study; patient, the nurse that examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solutions. Severity of stomatitis in experimental and control groups is similar.Inclusion criteria:undergoing chemotherapy; age above18 years old;having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness; no use another mouthwash solution during the study;do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants. Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time is be less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study. To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2).Patients 4 times a day,after breakfast,lunch, dinner and before sleeping,first,wash their hands,cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after mouth wash.Oral mucosa of patients and pain mouth of them on the first,seventh and fourteenth days after getting mouthwash checked by researcher or oncology nurse who does not know the mouthwash solution and then stomatitis and stomatiotis induced mouth pain checklist is completed.
empty
Background and the Purpose of the Study: stomatitis is a disturbing and prevalent side-effect of chemotherapy that disturbs patients and causes difficulties in patient’s drinking, eating and talking, and may results in infection and bleeding and eventually decrease quality of life .This study aimed to investigate the effect of the marshmallow root extract on treatment of Stomatitis due chemotherapy. Materials and Methods: This randomized controlled trial study was conducted during 2016.The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran. In this study, 50 patients diagnosed with cancer that undergoing chemoterapy were randomly assigned into control and experimental groups in similar blocks according to their stomatitis severity. In this study; patient, the nurse that examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solutions. Severity of stomatitis in experimental and control groups is similar.Inclusion criteria:undergoing chemotherapy; age above18 years old;having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness; no use another mouthwash solution during the study;do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants. Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time is be less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study. To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2).Patients 4 times a day,after breakfast,lunch, dinner and before sleeping,first,wash their hands,cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after mouth wash.Oral mucosa of patients and pain mouth of them on the first,seventh and fourteenth days after getting mouthwash checked by researcher or oncology nurse who does not know the mouthwash solution and then stomatitis and stomatiotis induced mouth pain checklist is completed.
استوماتیت یک عارضه شایع وناتوان کننده شیمی درمانی می باشد که موجب اختلال دردریافت مواد غذایی- مایعات و صحبت کردن، قطع درمان وکاهش کیفیت ذندگی وافزایش میزان مرگ و میر می شود. روشهای مختلفی جهت بهبود استوماتیت دراین بیماران استفاده می شود.این مطالعه باهدف بررسی اثرمحلول حاوی عصاره ریشه گیاه ختمی بربهبوداستوماتیت ناشی ازشیمی درمانی انجام شد. روش کار: این مطالعه کارآزمایی بالینی دوسوکوردربیماران مبتلا به سرطان مراجعه کننده به بیمارستان شهید بهشتی کاشان در سال 1395 که تحت شیمی درمانی بوده ودچاراستوماتیت دهانی شده اند وتحت درمان با یک داروی ضدالتهابی می باشندانجام می شود. دراین تحقیق 50 بیمار با کمک جدول اعداد تصادفی بر حسب شدت استوماتیت، در بلوک های مشابه قرار می گیرند. معیارهای ورودوخروج مطالعه شامل:قرارداشتن تحت شیمی درمانی، سن بالاتراز18سال،رضایت ازشرکت درمطالعه،نداشتن سابقه حساسیت وبیماریهای اتوایمیون،کبدی،کلیوی،عدم انجام رادیوتراپی،عدم مصرف انتی بیوتیک وضدقارچ سیستمیک درحین مطالعه می باشد به تمامی بیماران بعدازپذیرش شیشه های حاوی دهانشویه داده می شود گروه آزمون محلول حاوی:عصاره آبی ریشه ختمی8 درصد +آمپول لیدوکائین2%،شربت Al-mg-s،شربت دیفن هیدرامین(شیشه1)وگروه کنترل محلول روتین(لیدوکائین2%، شربت Al-mg-s،شربت دیفن هیدرامین وقطره نیستاتین)(شیشه2) دریافت می کنند ییماران 4 باردرروز،پس ازصرف صبحانه،نهار،شام وقبل ازخواب ابتدادستها را شسته،دندان ها رابامسواک نرم ویک نوع خمیردندان ملایم تمیز کرده ودرهربار15 سی سی ازمحلول دهانشویه رابه مدت 3 دقیقه در دهان خود نگه داشته وسپس دورمی ریزند.این بیماران نباید دهان خودرا بشویندوتایک ساعت ازمصرف موادغذایی خودداری کنند.با توجه به دوسوکور بودن مطالعه، مخاط دهان بیماران ودرددهانی آنها درروزهای اول، هفتم وچهاردهم توسط محقق یا پرستاربخش انکولوژی که از نوع دهانشویه بی اطلاع است بررسی شده شدت استوماتیت ودرد دهانی ناشی ازاستوماتیت ارزیابی وچک لیست مربوطه تکمیل می شود.
empty
استوماتیت یک عارضه شایع وناتوان کننده شیمی درمانی می باشد که موجب اختلال دردریافت مواد غذایی- مایعات و صحبت کردن، قطع درمان وکاهش کیفیت ذندگی وافزایش میزان مرگ و میر می شود. روشهای مختلفی جهت بهبود استوماتیت دراین بیماران استفاده می شود.این مطالعه باهدف بررسی اثرمحلول حاوی عصاره ریشه گیاه ختمی بربهبوداستوماتیت ناشی ازشیمی درمانی انجام شد. روش کار: این مطالعه کارآزمایی بالینی دوسوکوردربیماران مبتلا به سرطان مراجعه کننده به بیمارستان شهید بهشتی کاشان در سال 1395 که تحت شیمی درمانی بوده ودچاراستوماتیت دهانی شده اند وتحت درمان با یک داروی ضدالتهابی می باشندانجام می شود. دراین تحقیق 50 بیمار با کمک جدول اعداد تصادفی بر حسب شدت استوماتیت، در بلوک های مشابه قرار می گیرند. معیارهای ورودوخروج مطالعه شامل:قرارداشتن تحت شیمی درمانی، سن بالاتراز18سال،رضایت ازشرکت درمطالعه،نداشتن سابقه حساسیت وبیماریهای اتوایمیون،کبدی،کلیوی،عدم انجام رادیوتراپی،عدم مصرف انتی بیوتیک وضدقارچ سیستمیک درحین مطالعه می باشد به تمامی بیماران بعدازپذیرش شیشه های حاوی دهانشویه داده می شود گروه آزمون محلول حاوی:عصاره آبی ریشه ختمی8 درصد +آمپول لیدوکائین2%،شربت Al-mg-s،شربت دیفن هیدرامین(شیشه1)وگروه کنترل محلول روتین(لیدوکائین2%، شربت Al-mg-s،شربت دیفن هیدرامین وقطره نیستاتین)(شیشه2) دریافت می کنند ییماران 4 باردرروز،پس ازصرف صبحانه،نهار،شام وقبل ازخواب ابتدادستها را شسته،دندان ها رابامسواک نرم ویک نوع خمیردندان ملایم تمیز کرده ودرهربار15 سی سی ازمحلول دهانشویه رابه مدت 3 دقیقه در دهان خود نگه داشته وسپس دورمی ریزند.این بیماران نباید دهان خودرا بشویندوتایک ساعت ازمصرف موادغذایی خودداری کنند.با توجه به دوسوکور بودن مطالعه، مخاط دهان بیماران ودرددهانی آنها درروزهای اول، هفتم وچهاردهم توسط محقق یا پرستاربخش انکولوژی که از نوع دهانشویه بی اطلاع است بررسی شده شدت استوماتیت ودرد دهانی ناشی ازاستوماتیت ارزیابی وچک لیست مربوطه تکمیل می شود.
empty
Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
empty
مقایسه اثر محلول حاوی عصاره ریشه گیاه ختمی و محلول روتین بر بهبود استوماتیت ناشی ازشیمی درمانی
مقایسه اثر محلول حاوی عصاره ریشه گیاه ختمی و محلول روتین بر بهبود استوماتیت ناشی ازشیمی درمانی
empty
the group of routine mouth wash and group of "mouthwash solution" added to routine mouth wash
the group of routine mouth wash and group of "mouthwash solution" added to routine mouth wash
empty
گروه دریافت کننده دهانشویه روتین و دریافت کننده روتین + عصاره هیدروالکلی گل ختمی
گروه دریافت کننده دهانشویه روتین و دریافت کننده روتین + عصاره هیدروالکلی گل ختمی
empty
chemotherapy ward
chemotherapy ward
empty
بخش شیمی درمانی
بخش شیمی درمانی
empty
The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran
The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran
empty
این مطالعه کارآزمایی بالینی دوسوکوردربیماران مبتلا به سرطان مراجعه کننده به بیمارستان شهید بهشتی کاشان در سال 1395 که تحت شیمی درمانی بوده ودچاراستوماتیت دهانی شده اند وتحت درمان با یک داروی ضدالتهابی می باشند
این مطالعه کارآزمایی بالینی دوسوکوردربیماران مبتلا به سرطان مراجعه کننده به بیمارستان شهید بهشتی کاشان در سال 1395 که تحت شیمی درمانی بوده ودچاراستوماتیت دهانی شده اند وتحت درمان با یک داروی ضدالتهابی می باشند
empty
To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2)
To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2)
empty
به تمامی بیماران بعدازپذیرش شیشه های حاوی دهانشویه داده می شود گروه آزمون محلول حاوی:عصاره آبی ریشه ختمی8 درصد +آمپول لیدوکائین2%،شربت Al-mg-s،شربت دیفن هیدرامین(شیشه1)وگروه کنترل محلول روتین(لیدوکائین2%، شربت Al-mg-s،شربت دیفن هیدرامین وقطره نیستاتین)(شیشه2) دریافت می کنند
به تمامی بیماران بعدازپذیرش شیشه های حاوی دهانشویه داده می شود گروه آزمون محلول حاوی:عصاره آبی ریشه ختمی8 درصد +آمپول لیدوکائین2%،شربت Al-mg-s،شربت دیفن هیدرامین(شیشه1)وگروه کنترل محلول روتین(لیدوکائین2%، شربت Al-mg-s،شربت دیفن هیدرامین وقطره نیستاتین)(شیشه2) دریافت می کنند
empty
pain severity (VAS)
stomatitis stage (according to WHO)
pain severity (VAS) stomatitis stage (according to WHO)
empty
شدت درد
درجه استوماتیت
شدت درد درجه استوماتیت
General information
1
1
1
1
undergoing chemotherapy
age above18 years old
having consciousness
undergoing chemotherapy age above18 years old having consciousness
قرارداشتن تحت درمان شیمی درمانی
داشتن هوشیاری کامل
سن 18 سال و بالاتر
قرارداشتن تحت درمان شیمی درمانی داشتن هوشیاری کامل سن 18 سال و بالاتر
empty
sequential patient discharge allocated in 2 group in this study: intervention and control group by computer randomize program (spss)
sequential patient discharge allocated in 2 group in this study: intervention and control group by computer randomize program (spss)
empty
بیمارانی که به تدریج ترخیص میشوند تخصیص تصادفی بر اساس برنامه spss کامپیوتری به دو گروه مداخله و شاهد انجام خواهد شد
بیمارانی که به تدریج ترخیص میشوند تخصیص تصادفی بر اساس برنامه spss کامپیوتری به دو گروه مداخله و شاهد انجام خواهد شد
empty
patients have no information about the kind of consultation that receive
patients have no information about the kind of consultation that receive
empty
بیماران از بسته ای که دریافت می کنند اطلاع ندارند
بیماران از بسته ای که دریافت می کنند اطلاع ندارند
Recruitment centers
#1
Name of recruitment center - English: Shahid beheshti medical education Center of Kashan university of medical Sciences
Name of recruitment center - Persian: lمرکز اموزشی درمانی شهید بهشتی ,وابسته به دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadsi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Street address - English: Kashan University of Medical Sciences -Arctic Blvd Ravandi -
Street address - Persian: کیلومتر5 بلولرقطب راوندی-دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid beheshti medical education Center of Kashan university of medical Sciences
Name of recruitment center - Persian: lمرکز اموزشی درمانی شهید بهشتی ,وابسته به دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadsi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Street address - English: Kashan University of Medical Sciences -Arctic Blvd Ravandi -
Street address - Persian: کیلومتر5 بلولرقطب راوندی-دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Fax:
Email: taghadosi_m@kaums.ac.ir
Web page address:
Name of recruitment center - English: Shahid beheshti medical education Center of Kashan university of medical Sciences Name of recruitment center - Persian: lمرکز اموزشی درمانی شهید بهشتی ,وابسته به دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Taghadsi Mohsen Full name of responsible person - Persian: محسن تقدسی Street address - English: Kashan University of Medical Sciences -Arctic Blvd Ravandi - Street address - Persian: کیلومتر5 بلولرقطب راوندی-دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Fax: Email: taghadosi_m@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Hamidi Gholamali
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Hamidi Gholamali
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Fax:
Email: taghadosi_m@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Hamidi Gholamali Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences Street address - Persian: کیلومتر 5 بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Fax: Email: taghadosi_m@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Vice President of Research of Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadosi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Position - English: PhD -director of journal pheyz Department,Head of medical-surgical group
Position - Persian: دکترای پرستاری - مدیر مجله فیض, رئیس گروه داخلی جراحی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax: +98 31 5554 0021
Email: Taghadosi_m@kaums.ac.ir
Web page address: www.kaums.ac.ir
contact.organization_id:
Name of organization / entity - English: Vice President of Research of Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadosi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Position - English: PhD -Faculty member Assistant professor -director of journal pheyz Department,Head of medical-surgic
Position - Persian: دکترای تخصصی پرستاری داخلی جراحی - مدیر مجله فیض, رئیس گروه داخلی جراحی
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax: +98 31 5554 0021
Email: Taghadosi_m@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice President of Research of Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Taghadosi Mohsen Full name of responsible person - Persian: محسن تقدسی Position - English: PhD -Faculty member Assistant professor -director of journal pheyz Department,Head of medical-surgical groupsurgic Position - Persian: دکترای تخصصی پرستاری داخلی جراحی - مدیر مجله فیض, رئیس گروه داخلی جراحی Latest degree: phd Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Mobile: +98 913 363 4439 Fax: +98 31 5554 0021 Email: Taghadosi_m@kaums.ac.ir Web page address: www.kaums.ac.ir
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری ومامایی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadosi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Position - English: PhD of nursing - director of journal pheyz Department, director of medical surgical group
Position - Persian: دکترای پرستاری - مدیر مجله فیض،مدیرگروه داخلی جراحی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax: +98 31 5554 0021
Email: Taghadosi_m@kaums.ac.ir
Web page address: www.kaums.ac.ir
contact.organization_id:
Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری ومامایی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadosi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Position - English: PhD -Faculty member Assistant professor -director of journal pheyz Department,Head of medical-surgic
Position - Persian: دکترای تخصصی پرستاری داخلی جراحی - مدیر مجله فیض, مدیر گروه داخلی جراحی
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax: +98 31 5554 0021
Email: Taghadosi_m@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences Name of organization / entity - Persian: دانشکده پرستاری ومامایی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Taghadosi Mohsen Full name of responsible person - Persian: محسن تقدسی Position - English: PhD of nursing-Faculty member Assistant professor -director of journal pheyz Department, directorDepartment,Head of medical surgical group-surgic Position - Persian: دکترای تخصصی پرستاری داخلی جراحی - مدیر مجله فیض،مدیرگروه, مدیر گروه داخلی جراحی Latest degree: phd Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences Street address - Persian: کاشان - کیلومتر 5 بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Mobile: +98 913 363 4439 Fax: +98 31 5554 0021 Email: Taghadosi_m@kaums.ac.ir Web page address: www.kaums.ac.ir
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان - دانشکده پرستاری و مامایی
Full name of responsible person - English: ghorbani vadeghani Mohamadsadegh
Full name of responsible person - Persian: محمدصادق فربانی وادقانی
Position - English: MSc Student of Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری مراقبتهای ویژه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کیلومتر 5 بلوار قطب راوندی -دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 36 1555 0021
Mobile: +98 939 200 1864
Fax: +98 36 1555 6633
Email: g.mohamadsadegh@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان - دانشکده پرستاری و مامایی
Full name of responsible person - English: ghorbani vadeghani Mohamadsadegh
Full name of responsible person - Persian: محمدصادق فربانی وادقانی
Position - English: MSc Student of Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری مراقبتهای ویژه
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences
Street address - Persian: کیلومتر 5 بلوار قطب راوندی -دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 36 1555 0021
Mobile: +98 939 200 1864
Fax:
Email: taghadosi_m@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Faculty of Nursing & Midwifery,Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان - دانشکده پرستاری و مامایی Full name of responsible person - English: ghorbani vadeghani Mohamadsadegh Full name of responsible person - Persian: محمدصادق فربانی وادقانی Position - English: MSc Student of Nursing Position - Persian: دانشجوی کارشناسی ارشد پرستاری مراقبتهای ویژه Latest degree: bachelor Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arctic Blvd Ravandi - Kashan University of Medical Sciences Street address - Persian: کیلومتر 5 بلوار قطب راوندی -دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 36 1555 0021 Mobile: +98 939 200 1864 Fax: +98 36 1555 6633 Email: g.mohamadsadeghtaghadosi_m@gmail.comkaums.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no
no
empty
The total potential data can be shared after unidentifiable people
The total potential data can be shared after unidentifiable people
empty
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
empty
Start the access period 6 months after printing the results
Start the access period 6 months after printing the results
empty
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
empty
Only available to scholars working in academia and academia.
Only available to scholars working in academia and academia.
empty
فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
empty
If you observe the trust and mention the source, data is available for researchers.
If you observe the trust and mention the source, data is available for researchers.
empty
در صورت رعایت امانت داری و ذکر منبع، داده ها برای محققین قابل استفاده اند.
در صورت رعایت امانت داری و ذکر منبع، داده ها برای محققین قابل استفاده اند.
empty
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
empty
به آدرس پست الکترونیکی زیر نامه ارسال شود: taghadosi_m@kaums.ac.ir
به آدرس پست الکترونیکی زیر نامه ارسال شود: taghadosi_m@kaums.ac.ir
empty
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.
empty
پس از دریافت نامه از طریق ایمیل درخواست شما طی 2 هفته بررسی و در صورت صلاحدید داده ها برای متقاضی ارسال می گردد.
پس از دریافت نامه از طریق ایمیل درخواست شما طی 2 هفته بررسی و در صورت صلاحدید داده ها برای متقاضی ارسال می گردد.
Protocol summary
Study aim
Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
Design
the group of routine mouth wash and group of "mouthwash solution" added to routine mouth wash
Settings and conduct
chemotherapy ward
Participants/Inclusion and exclusion criteria
The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran
Intervention groups
To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2)
Main outcome variables
pain severity (VAS)
stomatitis stage (according to WHO)
General information
Reason for update
Acronym
Marshmallow root and ostomatitis
IRCT registration information
IRCT registration number:IRCT201307274655N4
Registration date:2016-07-14, 1395/04/24
Registration timing:prospective
Last update:2018-03-01, 1396/12/10
Update count:1
Registration date
2016-07-14, 1395/04/24
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
Public title
Effect of mouth wash contaning marshmallow root extract on improvement stomatitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
undergoing chemotherapy
age above18 years old
having consciousness
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
sequential patient discharge allocated in 2 group in this study: intervention and control group by computer randomize program (spss)
Blinding (investigator's opinion)
Double blinded
Blinding description
patients have no information about the kind of consultation that receive
Placebo
Used
Assignment
Parallel
Other design features
In this study, the following people were blind and did not know of the contents two glass:
1) The person who gave the glass to the patient and examine the patient oral mucosa.
2) Patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences- Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.KAUMS.REC.1395.10
Health conditions studied
1
Description of health condition studied
Stomstitis
ICD-10 code
K12.1
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
ostomatitis
Timepoint
Before and seventh and fourteenth days after the intervention
Method of measurement
Standardized checklist stomatitis WHO
Secondary outcomes
1
Description
Change grade of stomatitis
Timepoint
Beforebefore and seventh and fourteenth days after the intervention
Method of measurement
Standardized checklist stomatitis WHO
Intervention groups
1
Description
The intervention group use solution of routine mouthwash plus hydro alcholic extract of marshmallow root that each 100m.l of that contains :lidocaine 2% 50 mg ,Al-mg-s syrup 25 ml,Diphen hydramine surp12.5cc(31.25mg) and 60 cc hydro alcholic marshmallow extract root 8% (glass 1).Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.
Category
Treatment - Drugs
2
Description
Control group use routine mouthwash solution that100 ml of that containing :lidocaine 2%100mg, Al-mg-s syrup55 ml , Diphenhydramine syrup 28 cc(70mg),nystatin dpop1,200,000 unit(12cc)(glass 2).Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after.oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti medical education Center of Kashan university of medical Sciences
Full name of responsible person
Taghadsi Mohsen
Street address
Kashan University of Medical Sciences -Arctic Blvd Ravandi -
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Vice President of Research of Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD -Faculty member Assistant professor -director of journal pheyz Department,Head of medical-surgic
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD -Faculty member Assistant professor -director of journal pheyz Department,Head of medical-surgic
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
ghorbani vadeghani Mohamadsadegh
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
Email
taghadosi_m@kaums.ac.ir
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
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia and academia.
Under which criteria data/document could be used
If you observe the trust and mention the source, data is available for researchers.
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.