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Protocol summary
This study is a clinical trial to evaluate the effects of oral propolis supplement and topical propolis treatment on diabetic foot ulcers. In this randomized trial, 80 patients with diabetic foot ulcers grade 1 and 2, based on the University of Texas Foot Wound Classification System who are under the standard treatment, will be included. Eligible patients will randomly be divided into four groups using a table of random numbers. The first group will receive oral capsules containing five hundred milligram propolis, 3 times a day. The second group will receive propolis ointment, 1.5 g a day. Group 3 will receive both Propolis oral capsule and Propolis ointment and Group IV will receive conventional treatment of diabetic foot ulcers including rinse with saline daily. In this study, diabetic foot ulcer area, the leukocytes and pathogenic bacteria present in the wound are the main outcomes.
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This study is a clinical trial to evaluate the effects of oral propolis supplement and topical propolis treatment on diabetic foot ulcers. In this randomized trial, 80 patients with diabetic foot ulcers grade 1 and 2, based on the University of Texas Foot Wound Classification System who are under the standard treatment, will be included. Eligible patients will randomly be divided into four groups using a table of random numbers. The first group will receive oral capsules containing five hundred milligram propolis, 3 times a day. The second group will receive propolis ointment, 1.5 g a day. Group 3 will receive both Propolis oral capsule and Propolis ointment and Group IV will receive conventional treatment of diabetic foot ulcers including rinse with saline daily. In this study, diabetic foot ulcer area, the leukocytes and pathogenic bacteria present in the wound are the main outcomes.
این مطالعه از نوع کارآزمایی بالینی به منظور ارزیابی و مقایسه اثرات بره موم خوراکی با بره موم موضعی در درمان زخم پای دیابتی طراحی شده است. طی این کارآزمایی اتفاقی شده، 80 بیمار با زخم پای دیابتی با گرید 1 و 2 که بر اساس University of Texas Foot Wound Classification System می باشند و تنها درمان استاندارد و متداول را دریافت می کنند مورد مطالعه قرار میگیرند.
افراد واجد شرایط به طور تصادفی و با استفاده از جدول اعداد تصادفي به چهار گروه تقسیم بندی خواهند شد. به گروه اول روزی سه عدد کپسول پانصد میلی گرمی حاوی بره موم، گروه دوم بره موم به صورت پماد(روزانه 1/5 گرم)، گروه سوم کپسول و بره موم به صورت پماد و گروه چهارم درمان معمولی زخم پا شامل شستشو با سرم فیزیولوژی را دریافت خواهند کرد. طی این مطالعه، مساحت زخم پای دیابتی، میزان لکوسیت ها و باکتری های پاتوژن موجود در زخم مورد ارزیابی قرار می گیرند.
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این مطالعه از نوع کارآزمایی بالینی به منظور ارزیابی و مقایسه اثرات بره موم خوراکی با بره موم موضعی در درمان زخم پای دیابتی طراحی شده است. طی این کارآزمایی اتفاقی شده، 80 بیمار با زخم پای دیابتی با گرید 1 و 2 که بر اساس University of Texas Foot Wound Classification System می باشند و تنها درمان استاندارد و متداول را دریافت می کنند مورد مطالعه قرار میگیرند. افراد واجد شرایط به طور تصادفی و با استفاده از جدول اعداد تصادفي به چهار گروه تقسیم بندی خواهند شد. به گروه اول روزی سه عدد کپسول پانصد میلی گرمی حاوی بره موم، گروه دوم بره موم به صورت پماد(روزانه 1/5 گرم)، گروه سوم کپسول و بره موم به صورت پماد و گروه چهارم درمان معمولی زخم پا شامل شستشو با سرم فیزیولوژی را دریافت خواهند کرد. طی این مطالعه، مساحت زخم پای دیابتی، میزان لکوسیت ها و باکتری های پاتوژن موجود در زخم مورد ارزیابی قرار می گیرند.
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Determination and comparison of the effects of oral and topical propolis on the area of foot ulcer, leukocyte count, pathogenic bacteria, total antioxidant capacity and malondialdehyde
Determination and comparison of the effects of oral and topical propolis on the area of foot ulcer, leukocyte count, pathogenic bacteria, total antioxidant capacity and malondialdehyde
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تعیین و مقایسه اثرات بره موم خوراکی و موضعی بر مساحت زخم پا، میزان لکوسیت ها، باکتری های پاتوژن، ظرفیت آنتی اکسیدانی تام و مالون دی آلدئید
تعیین و مقایسه اثرات بره موم خوراکی و موضعی بر مساحت زخم پا، میزان لکوسیت ها، باکتری های پاتوژن، ظرفیت آنتی اکسیدانی تام و مالون دی آلدئید
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In this trial, 80 patients with diabetic foot ulcers with Grade 1 and 2, which are based on the University of Texas Foot Wound Classification System, are only being studied for standard and common treatment. Qualified individuals will be randomly assigned to four groups using the random numbers table.
In this trial, 80 patients with diabetic foot ulcers with Grade 1 and 2, which are based on the University of Texas Foot Wound Classification System, are only being studied for standard and common treatment. Qualified individuals will be randomly assigned to four groups using the random numbers table.
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در این کارآزمایی، 80 بیمار با زخم پای دیابتی با گرید 1 و 2 که بر اساس University of Texas Foot Wound Classification System می باشند و تنها درمان استاندارد و متداول را دریافت می کنند مورد مطالعه قرار میگیرند. افراد واجد شرایط به طور تصادفی و با استفاده از جدول اعداد تصادفي به چهار گروه تقسیم بندی خواهند شد.
در این کارآزمایی، 80 بیمار با زخم پای دیابتی با گرید 1 و 2 که بر اساس University of Texas Foot Wound Classification System می باشند و تنها درمان استاندارد و متداول را دریافت می کنند مورد مطالعه قرار میگیرند. افراد واجد شرایط به طور تصادفی و با استفاده از جدول اعداد تصادفي به چهار گروه تقسیم بندی خواهند شد.
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This study is a clinical trial. In this trial, diabetic patients with diabetic foot ulcers referred to Shahid Beheshti Clinic of Qom University of Medical Sciences are enrolled. Then, 80 patients were randomly assigned to four intervention and control groups.
This study is a clinical trial. In this trial, diabetic patients with diabetic foot ulcers referred to Shahid Beheshti Clinic of Qom University of Medical Sciences are enrolled. Then, 80 patients were randomly assigned to four intervention and control groups.
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این مطالعه از نوع کارآزمایی بالینی می باشد. در این کارآزمایی، افراد دیابتی با زخم پای دیابتی مراجعه کننده به کلینیک فوق تخصصی شهید بهشتی دانشگاه علوم پزشکی قم وارد مطالعه می شوند. سپس 80 بیمار انتخاب شده و بصورت تصادفی به چهار گروه مداخله و کنترل تقسیم میشوند.
این مطالعه از نوع کارآزمایی بالینی می باشد. در این کارآزمایی، افراد دیابتی با زخم پای دیابتی مراجعه کننده به کلینیک فوق تخصصی شهید بهشتی دانشگاه علوم پزشکی قم وارد مطالعه می شوند. سپس 80 بیمار انتخاب شده و بصورت تصادفی به چهار گروه مداخله و کنترل تقسیم میشوند.
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Diabetic people with foot ulcer
Diabetic people with foot ulcer
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افراد دیابتی مبتلا به زخم پا
افراد دیابتی مبتلا به زخم پا
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First intervention group: Three capsules of 500 mg of propolis (daily), Second intervention group: Propolis ointment (1.5 g daily), Third intervention group: Propolis (1500 mg daily) and propolis Ointment (1.5 g daily), Control group: Regular foot wound treatment includes washing with serum physiology
First intervention group: Three capsules of 500 mg of propolis (daily), Second intervention group: Propolis ointment (1.5 g daily), Third intervention group: Propolis (1500 mg daily) and propolis Ointment (1.5 g daily), Control group: Regular foot wound treatment includes washing with serum physiology
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گروه مداخله اول: سه عدد کپسول پانصد میلی گرمی بره موم (روزانه)، گروه مداخله دوم: بره موم به صورت پماد(روزانه 1/5گرم)، گروه مداخله سوم: کپسول بره موم (روزانه 1500 میلی گرم) و بره موم به صورت پماد (روزانه 1/5گرم)، گروه کنترل: درمان معمولی زخم پا شامل شستشو با سرم فیزیولوژی
گروه مداخله اول: سه عدد کپسول پانصد میلی گرمی بره موم (روزانه)، گروه مداخله دوم: بره موم به صورت پماد(روزانه 1/5گرم)، گروه مداخله سوم: کپسول بره موم (روزانه 1500 میلی گرم) و بره موم به صورت پماد (روزانه 1/5گرم)، گروه کنترل: درمان معمولی زخم پا شامل شستشو با سرم فیزیولوژی
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Area of foot ulcer, leukocyte count, pathogenic bacteria
Area of foot ulcer, leukocyte count, pathogenic bacteria
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مساحت زخم پا، تعداد لوکوسیت ها، باکتری های پاتوژن
مساحت زخم پا، تعداد لوکوسیت ها، باکتری های پاتوژن
General information
Patients with diabetic foot ulcers grade 1 and 2
Willingness to cooperate
Patients with diabetic foot ulcers grade 1 and 2 Willingness to cooperate
بيماران با زخم پای دیابتی با گرید 1 و 2
تمایل به همکاری
بيماران با زخم پای دیابتی با گرید 1 و 2 تمایل به همکاری
Patients with wounds functions deep grade and step higher than 1 and 2
Sensitivity to topical formulation
Patients with wounds functions deep grade and step higher than 1 and 2 Sensitivity to topical formulation
بيماران با زخمھاي عمقي درجه و مرحله بالاتر از 1 و 2
حساسيت به فورمولاسيون موضعي
بيماران با زخمھاي عمقي درجه و مرحله بالاتر از 1 و 2 حساسيت به فورمولاسيون موضعي
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Simple randomization
Simple randomization
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تصادفی سازی ساده
تصادفی سازی ساده
Primary outcomes
#1
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Total Antioxidant Capacity
Total Antioxidant Capacity
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ظرفیت تام آنتی اکسیدانی
ظرفیت تام آنتی اکسیدانی
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The beginning and End of the study
The beginning and End of the study
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اول و آخر مطالعه
اول و آخر مطالعه
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Eliza kit
Eliza kit
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کیت الیزا
کیت الیزا
#2
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ُserum Malondialdehyde
ُserum Malondialdehyde
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مالون دی آلدئید سرم
مالون دی آلدئید سرم
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The beginning and End of the study
The beginning and End of the study
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اول و آخر مطالعه
اول و آخر مطالعه
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Eliza kit
Eliza kit
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کیت الیزا
کیت الیزا
Recruitment centers
#1
Name of recruitment center - English: Metabolism and Endocrinology clinic martyr Beheshti Hospital in Qom
Name of recruitment center - Persian: کلینیک فوق تخصصی متابولیسم و غدد بیمارستان شهید بهشتی قم
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar blvd.
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qom
City - Persian: قم
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Metabolism and Endocrinology clinic martyr Beheshti Hospital in Qom
Name of recruitment center - Persian: کلینیک فوق تخصصی متابولیسم و غدد بیمارستان شهید بهشتی قم
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar blvd.
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qom
City - Persian: قم
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34197-59811
Phone: +98 28 3333 6001
Fax:
Email: khademnut@yahoo.com
Web page address:
Name of recruitment center - English: Metabolism and Endocrinology clinic martyr Beheshti Hospital in Qom Name of recruitment center - Persian: کلینیک فوق تخصصی متابولیسم و غدد بیمارستان شهید بهشتی قم Full name of responsible person - English: Dr. Hossein Khadem Haghighian Full name of responsible person - Persian: دکتر حسین خادم حقیقیان Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar blvd. Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین City - English: Qom City - Persian: قم Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 34197-59811 Phone: +98 28 3333 6001 Fax: Email: khademnut@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Qazvin University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Taghi Naserpour
Full name of responsible person - Persian: دکتر تقی ناصرپور
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
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, Qazvin University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Taghi Naserpour
Full name of responsible person - Persian: دکتر تقی ناصرپور
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 34197-59811
Phone: +98 28 3333 6001
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Qazvin University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Dr. Taghi Naserpour Full name of responsible person - Persian: دکتر تقی ناصرپور Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین City - English: Qazvin City - Persian: قزوین Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 34197-59811 Phone: +98 28 3333 6001 Fax: Email: khademnut@yahoo.com Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
Position - English: Ph.D in Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 28 3732 7650
Mobile: 00
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
Position - English: Ph.D in Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34197-59811
Phone: +98 28 3732 7650
Mobile: +98 914 837 5283
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Qazvin University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Dr. Hossein Khadem Haghighian Full name of responsible person - Persian: دکتر حسین خادم حقیقیان Position - English: Ph.D in Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34197-59811 Phone: +98 28 3732 7650 Mobile: 00+98 914 837 5283 Fax: Email: khademnut@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر جسین خادم حقیقیان
Position - English: Ph.D in Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 28 3732 7650
Mobile: 00
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر جسین خادم حقیقیان
Position - English: Ph.D in Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34197-59811
Phone: +98 28 3732 7650
Mobile: +98 914 837 5283
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Qazvin University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Dr. Hossein Khadem Haghighian Full name of responsible person - Persian: دکتر جسین خادم حقیقیان Position - English: Ph.D in Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34197-59811 Phone: +98 28 3732 7650 Mobile: 00+98 914 837 5283 Fax: Email: khademnut@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
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: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 28 3732 7650
Mobile: 00
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Dr. Hossein Khadem Haghighian
Full name of responsible person - Persian: دکتر حسین خادم حقیقیان
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34197-59811
Phone: +98 28 3732 7650
Mobile: +98 914 837 5283
Fax:
Email: khademnut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Qazvin University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Dr. Hossein Khadem Haghighian Full name of responsible person - Persian: دکتر حسین خادم حقیقیان Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin Street address - Persian: قزوین، بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34197-59811 Phone: +98 28 3732 7650 Mobile: 00+98 914 837 5283 Fax: Email: khademnut@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
no
no
yes
yes
yes
yes
no
no
yes
yes
empty
Data on primary and secondary outcomes will be published.
Data on primary and secondary outcomes will be published.
empty
داده های مربوط به پیامدهای اولیه و ثانویه منتشر خواهند شد.
داده های مربوط به پیامدهای اولیه و ثانویه منتشر خواهند شد.
empty
After completing the study and analyzing the data
After completing the study and analyzing the data
empty
بعد از اتمام مطالعه و آنالیز داده ها
بعد از اتمام مطالعه و آنالیز داده ها
empty
All researchers
All researchers
empty
همه محققین
همه محققین
empty
There is no objection to the use of data provided the source of the resource.
There is no objection to the use of data provided the source of the resource.
empty
استفاده از داده ها به شرط ذکر منبع ایرادی ندارد.
استفاده از داده ها به شرط ذکر منبع ایرادی ندارد.
empty
IRCT site
IRCT site
empty
به سایت IRCT
به سایت IRCT
empty
There is no objection to the use of data provided the source of the resource.
There is no objection to the use of data provided the source of the resource.
empty
استفاده از داده ها به شرط ذکر منبع ایرادی ندارد
استفاده از داده ها به شرط ذکر منبع ایرادی ندارد
Protocol summary
Study aim
Determination and comparison of the effects of oral and topical propolis on the area of foot ulcer, leukocyte count, pathogenic bacteria, total antioxidant capacity and malondialdehyde
Design
In this trial, 80 patients with diabetic foot ulcers with Grade 1 and 2, which are based on the University of Texas Foot Wound Classification System, are only being studied for standard and common treatment. Qualified individuals will be randomly assigned to four groups using the random numbers table.
Settings and conduct
This study is a clinical trial. In this trial, diabetic patients with diabetic foot ulcers referred to Shahid Beheshti Clinic of Qom University of Medical Sciences are enrolled. Then, 80 patients were randomly assigned to four intervention and control groups.
Participants/Inclusion and exclusion criteria
Diabetic people with foot ulcer
Intervention groups
First intervention group: Three capsules of 500 mg of propolis (daily), Second intervention group: Propolis ointment (1.5 g daily), Third intervention group: Propolis (1500 mg daily) and propolis Ointment (1.5 g daily), Control group: Regular foot wound treatment includes washing with serum physiology
Main outcome variables
Area of foot ulcer, leukocyte count, pathogenic bacteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017040419669N3
Registration date:2017-04-15, 1396/01/26
Registration timing:registered_while_recruiting
Last update:2018-05-02, 1397/02/12
Update count:1
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of oral propolis with topical propolis on diabetic foot ulcer
Public title
Effects of propolis on diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcers grade 1 and 2
Willingness to cooperate
Exclusion criteria:
Patients with wounds functions deep grade and step higher than 1 and 2
Sensitivity to topical formulation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.QUMS.REC.1395.294
Health conditions studied
1
Description of health condition studied
Diabetic food ulcers
ICD-10 code
L97
ICD-10 code description
Ulcer of lower limb, not elsewhere classified
Primary outcomes
1
Description
Area of diabetic foot ulcers
Timepoint
The beginning and End of the study
Method of measurement
With AutoCAD software
2
Description
Average leukocytes in diabetic foot ulcers
Timepoint
The beginning and End of the study
Method of measurement
The sampling
3
Description
The number of pathogenic bacteria
Timepoint
The beginning and End of the study
Method of measurement
The Sampling and culture
4
Description
Total Antioxidant Capacity
Timepoint
The beginning and End of the study
Method of measurement
Eliza kit
5
Description
ُserum Malondialdehyde
Timepoint
The beginning and End of the study
Method of measurement
Eliza kit
Secondary outcomes
empty
Intervention groups
1
Description
Control group : Rinse with saline daily
Category
Treatment - Drugs
2
Description
Intervention group 3: 1500 mg Propolis ointment for topical use on the ulcer and 1500 mg Propolis capsules (three 500 mg capsules), daily for 4 weeks.
Category
Treatment - Drugs
3
Description
Intervention group 2: 1500 mg Propolis ointment for topical use on the ulcer, daily for 4 weeks.
Category
Treatment - Drugs
4
Description
Intervention group 1: Propolis capsules, 1500 mg(three 500 mg capsules), daily for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Metabolism and Endocrinology clinic martyr Beheshti Hospital in Qom
Full name of responsible person
Dr. Hossein Khadem Haghighian
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qom
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Ph.D in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Ph.D in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on primary and secondary outcomes will be published.
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
IRCT site
What processes are involved for a request to access data/document
There is no objection to the use of data provided the source of the resource.