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Protocol summary
The purpose of this study is comparing the effect of adding acupuncture to medication with medication alone on cardiac and autonomic function in patients with heart failure. 72 patients with class II and III heart failure and ejection fraction less than 40% will be entered into this study and will randomly be divided into two groups of intervention (acupuncture and medication) and control (medication alone). The cardiologist and statistician will be blind to the assigned groups. The acupuncturist and patients will not be blind to the type of treatment. Randomization will be done using the Fleiss table. Patients older than 21 years of age with stable and compensated heart failure, class 2 and 3, and left ventricular ejection fraction less than or equal to 40% will be included. The exclusion criteria are history of acupuncture in the last 3 months and coagulative disorders. The duration of the intervention will be 4 weeks. In the intervention group, acupuncture will be performed three times a week. The primary outcome is cardiac and autonomic function based on electrocardiography, echocardiography, 6-minute walk test, heart rate and blood pressure that will be evaluated before the study and at week 8. Secondary outcomes include quality of life and symptoms of heart failure that will be examined before the study and at week 8.
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The purpose of this study is comparing the effect of adding acupuncture to medication with medication alone on cardiac and autonomic function in patients with heart failure. 72 patients with class II and III heart failure and ejection fraction less than 40% will be entered into this study and will randomly be divided into two groups of intervention (acupuncture and medication) and control (medication alone). The cardiologist and statistician will be blind to the assigned groups. The acupuncturist and patients will not be blind to the type of treatment. Randomization will be done using the Fleiss table. Patients older than 21 years of age with stable and compensated heart failure, class 2 and 3, and left ventricular ejection fraction less than or equal to 40% will be included. The exclusion criteria are history of acupuncture in the last 3 months and coagulative disorders. The duration of the intervention will be 4 weeks. In the intervention group, acupuncture will be performed three times a week. The primary outcome is cardiac and autonomic function based on electrocardiography, echocardiography, 6-minute walk test, heart rate and blood pressure that will be evaluated before the study and at week 8. Secondary outcomes include quality of life and symptoms of heart failure that will be examined before the study and at week 8.
هدف از انجام مطالعه، مقایسه اثر افزودن طب سوزنی به درمان دارویی با درمان دارویی به تنهایی بر عملکرد قلبی و اتونوم در بیماران مبتلا به نارسایی قلبی است.
72 بیمار مبتلا به نارسایی قلبی کلاس 2 و 3 و کسر جهشی کمتر از 40% به این مطالعه وارد می شوند و به صورت تصادفی به دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی) اختصاص خواهند یافت. متخصص قلب و متخصص آمار نسبت به گروه تخصیص یافته، کور خواهند بود. پزشک درمانگر طب سوزنی و بیماران نسبت به نوع درمان کور نخواهند بود. تصادفی سازی با استفاده از جدول Fleiss انجام شد.
بیماران با سن بیشتر یا مساوی 21 سال با نارسایی مزمن قلبی پایدار و جبران شده کلاس 2 و 3 و کسر جهشی بطن چپ کمتر یا مساوی 40% وارد مطالعه خواهند شد. معیارهای عدم ورود، سابقه ی طب سوزنی در 3 ماه اخیر و اختلالات انعقادی است.
مدت زمان انجام مداخله 4 هفته خواهد بود. در گروه مداخله، طب سوزنی سه بار در هفته برای بیماران انجام خواهد شد.
پیامد اولیه، عملکرد قلبی و اتونوم بر اساس الکتروکاردیوگرافی، اکوکاردیوگرافی، تست پیاده روی 6 دقیقه ای، ضربان قلب و فشار خون است که قبل از مطالعه و در هفته 8 ارزیابی خواهند شد. پیامد های ثانویه شامل کیفیت زندگی و علایم نارسایی قلبی است که قبل از مطالعه و در هفته 8 بررسی خواهند شد.
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هدف از انجام مطالعه، مقایسه اثر افزودن طب سوزنی به درمان دارویی با درمان دارویی به تنهایی بر عملکرد قلبی و اتونوم در بیماران مبتلا به نارسایی قلبی است. 72 بیمار مبتلا به نارسایی قلبی کلاس 2 و 3 و کسر جهشی کمتر از 40% به این مطالعه وارد می شوند و به صورت تصادفی به دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی) اختصاص خواهند یافت. متخصص قلب و متخصص آمار نسبت به گروه تخصیص یافته، کور خواهند بود. پزشک درمانگر طب سوزنی و بیماران نسبت به نوع درمان کور نخواهند بود. تصادفی سازی با استفاده از جدول Fleiss انجام شد. بیماران با سن بیشتر یا مساوی 21 سال با نارسایی مزمن قلبی پایدار و جبران شده کلاس 2 و 3 و کسر جهشی بطن چپ کمتر یا مساوی 40% وارد مطالعه خواهند شد. معیارهای عدم ورود، سابقه ی طب سوزنی در 3 ماه اخیر و اختلالات انعقادی است. مدت زمان انجام مداخله 4 هفته خواهد بود. در گروه مداخله، طب سوزنی سه بار در هفته برای بیماران انجام خواهد شد. پیامد اولیه، عملکرد قلبی و اتونوم بر اساس الکتروکاردیوگرافی، اکوکاردیوگرافی، تست پیاده روی 6 دقیقه ای، ضربان قلب و فشار خون است که قبل از مطالعه و در هفته 8 ارزیابی خواهند شد. پیامد های ثانویه شامل کیفیت زندگی و علایم نارسایی قلبی است که قبل از مطالعه و در هفته 8 بررسی خواهند شد.
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The purpose of this study is comparing the effect of adding acupuncture to medication with medication alone on cardiac and autonomic function in patients with heart failure.
The purpose of this study is comparing the effect of adding acupuncture to medication with medication alone on cardiac and autonomic function in patients with heart failure.
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هدف از انجام مطالعه، مقایسه اثر افزودن طب سوزنی به درمان دارویی با درمان دارویی به تنهایی بر عملکرد قلبی و اتونوم در بیماران مبتلا به نارسایی قلبی است.
هدف از انجام مطالعه، مقایسه اثر افزودن طب سوزنی به درمان دارویی با درمان دارویی به تنهایی بر عملکرد قلبی و اتونوم در بیماران مبتلا به نارسایی قلبی است.
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clinical trial with intervention and control group, single blind randomized trial with fleiss table, each groupncontain 36 member
clinical trial with intervention and control group, single blind randomized trial with fleiss table, each groupncontain 36 member
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کارآزمایی بالینی دارای گروه مداخله و کنترل، یک سو کور، تصادفی شده با استفاده از جدول fleiss، هر گروه شامل 36 عضو
کارآزمایی بالینی دارای گروه مداخله و کنترل، یک سو کور، تصادفی شده با استفاده از جدول fleiss، هر گروه شامل 36 عضو
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heart failure clinic of Imam Reza Hospital, Mashhad
72 patients with class II and III heart failure and ejection fraction less than 40% will be entered into this study and will randomly be divided into two groups of intervention (acupuncture and medication) and control (medication alone).
In the intervention group, acupuncture will be performed three times a week.
The cardiologist and statistician will be blind to the assigned groups. The acupuncturist and patients will not be blind to the type of treatment.
heart failure clinic of Imam Reza Hospital, Mashhad 72 patients with class II and III heart failure and ejection fraction less than 40% will be entered into this study and will randomly be divided into two groups of intervention (acupuncture and medication) and control (medication alone). In the intervention group, acupuncture will be performed three times a week. The cardiologist and statistician will be blind to the assigned groups. The acupuncturist and patients will not be blind to the type of treatment.
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بيمارستان امام رضا (ع)، درمانگاه نارسایی قلب و طب سوزنی
72 بیمار مبتلا به نارسایی قلبی کلاس 2 و 3 و کسر جهشی کمتر از 40% به این مطالعه وارد می شوند و به صورت تصادفی به دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی) اختصاص خواهند یافت.
در گروه مداخله، طب سوزنی سه بار در هفته برای بیماران انجام خواهد شد.
متخصص قلب و متخصص آمار نسبت به گروه تخصیص یافته، کور خواهند بود. پزشک درمانگر طب سوزنی و بیماران نسبت به نوع درمان کور نخواهند بود.
بيمارستان امام رضا (ع)، درمانگاه نارسایی قلب و طب سوزنی 72 بیمار مبتلا به نارسایی قلبی کلاس 2 و 3 و کسر جهشی کمتر از 40% به این مطالعه وارد می شوند و به صورت تصادفی به دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی) اختصاص خواهند یافت. در گروه مداخله، طب سوزنی سه بار در هفته برای بیماران انجام خواهد شد. متخصص قلب و متخصص آمار نسبت به گروه تخصیص یافته، کور خواهند بود. پزشک درمانگر طب سوزنی و بیماران نسبت به نوع درمان کور نخواهند بود.
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Patients older than 21 years of age with stable and compensated heart failure, class 2 and 3, and left ventricular ejection fraction less than or equal to 40% will be included.
Patients older than 21 years of age with stable and compensated heart failure, class 2 and 3, and left ventricular ejection fraction less than or equal to 40% will be included.
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بیماران با سن بیشتر یا مساوی 21 سال با نارسایی مزمن قلبی پایدار و جبران شده کلاس 2 و 3 و کسر جهشی بطن چپ کمتر یا مساوی 40% وارد مطالعه خواهند شد.
بیماران با سن بیشتر یا مساوی 21 سال با نارسایی مزمن قلبی پایدار و جبران شده کلاس 2 و 3 و کسر جهشی بطن چپ کمتر یا مساوی 40% وارد مطالعه خواهند شد.
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Two groups of intervention (acupuncture and medication) and control (medication alone)
Two groups of intervention (acupuncture and medication) and control (medication alone)
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دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی)
دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی به تنهایی)
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electrocardiography, echocardiography, 6-minute walk test, heart rate and blood pressure
electrocardiography, echocardiography, 6-minute walk test, heart rate and blood pressure
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الکتروکاردیوگرافی، اکوکاردیوگرافی، تست پیاده روی 6 دقیقه ای، ضربان قلب و فشار خون
الکتروکاردیوگرافی، اکوکاردیوگرافی، تست پیاده روی 6 دقیقه ای، ضربان قلب و فشار خون
General information
2017-08-01, 1396/05/10
2017-10-22, 1396/07/30
2017-0810-0122 00:00:00
2017-10-01, 1396/07/09
2018-03-11, 1396/12/20
20172018-1003-0111 00:00:00
Age>= 21
Heart failure with reduced ejection fraction (LVEF ≤40%)
New York Heart Association class II-III
sinus rhythm
patient consent
Age>= 21 Heart failure with reduced ejection fraction (LVEF ≤40%) New York Heart Association class II-III sinus rhythm patient consent
سن ≥ 21 سال
نارسایی مزمن قلبی با کسر جهشی کاهش یافته (LVEF ≤40%)
New York Heart Association class II-III
ریتم سینوسی
رضایت بیمار
سن ≥ 21 سال نارسایی مزمن قلبی با کسر جهشی کاهش یافته (LVEF ≤40%) New York Heart Association class II-III ریتم سینوسی رضایت بیمار
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Patients randomized into intervention group (real acupuncture + medication) and control group (medication) by random allocation with Fleiss table.
Patients randomized into intervention group (real acupuncture + medication) and control group (medication) by random allocation with Fleiss table.
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بیماران در دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی) با استفادهّ از جدول Fleiss به صورت تصادفی وارد شدند.
بیماران در دو گروه مداخله (طب سوزنی و درمان دارویی) و کنترل (درمان دارویی) با استفادهّ از جدول Fleiss به صورت تصادفی وارد شدند.
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In this study patients were not blind. the cardiologist was blind about study groups but it was not possible about acupuncturist. the questioner was not blind but the analyzer was blind.
In this study patients were not blind. the cardiologist was blind about study groups but it was not possible about acupuncturist. the questioner was not blind but the analyzer was blind.
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در این مطالعه بیماران نسبت به نوع درمان کور نبودند. متخصص قلب و عروق نسبت به گروههای مطالعه کورسازی شد اما امکان کورسازی متخصص طب سوزنی میسر نبود. کمک پژوهشگر (پرسشگر) نیز کور نبود اما تحلیل گر آماری نسبت به گروههای مطالعه کورسازی شد
در این مطالعه بیماران نسبت به نوع درمان کور نبودند. متخصص قلب و عروق نسبت به گروههای مطالعه کورسازی شد اما امکان کورسازی متخصص طب سوزنی میسر نبود. کمک پژوهشگر (پرسشگر) نیز کور نبود اما تحلیل گر آماری نسبت به گروههای مطالعه کورسازی شد
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Recruitment centers
#1
Name of recruitment center - English: Cardiology clinic, Imam Reza Hospital
Name of recruitment center - Persian: درمانگاه قلب بیمارستان امام رضا (ع)
Full name of responsible person - English: Dr. Farveh Vakilian
Full name of responsible person - Persian: دکتر فروه وکیلیان
Street address - English: Cardiology clinic, Imam Reza Hospital, Ibn Sina street, Mashhad
Street address - Persian: مشهد، خیابان ابن سینا، بیمارستان امام رضا (ع)، درمانگاه قلب
City - English: Mashhahd
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Cardiology clinic, Imam Reza Hospital
Name of recruitment center - Persian: درمانگاه قلب بیمارستان امام رضا (ع)
Full name of responsible person - English: Dr. Farveh Vakilian
Full name of responsible person - Persian: دکتر فروه وکیلیان
Street address - English: Cardiology clinic, Imam Reza Hospital, Ibn Sina street, Mashhad
Street address - Persian: مشهد، خیابان ابن سینا، بیمارستان امام رضا (ع)، درمانگاه قلب
City - English: Mashhahd
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone:
Fax:
Email: vakilianf@mums.ac.ir
Web page address:
Name of recruitment center - English: Cardiology clinic, Imam Reza Hospital Name of recruitment center - Persian: درمانگاه قلب بیمارستان امام رضا (ع) Full name of responsible person - English: Dr. Farveh Vakilian Full name of responsible person - Persian: دکتر فروه وکیلیان Street address - English: Cardiology clinic, Imam Reza Hospital, Ibn Sina street, Mashhad Street address - Persian: مشهد، خیابان ابن سینا، بیمارستان امام رضا (ع)، درمانگاه قلب City - English: Mashhahd City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: Fax: Email: vakilianf@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for research of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: University Central building, Daneshgah street
Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه
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 of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: University Central building, Daneshgah street
Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone:
Fax:
Email: tafaghodim@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for research of Mashhad University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr Mohsen Tafaghodi Full name of responsible person - Persian: دکتر محسن تفقدی Street address - English: University Central building, Daneshgah street Street address - Persian: خیابان دانشگاه، سازمان مرکزی دانشگاه City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: Fax: Email: tafaghodim@mums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Department of Cardiology, School of Medicine, Mashhad University of Medical Sciences
Name of organization / entity - Persian: گروه قلب و عروق، دانشکده پزشکی، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Farveh Vakilian
Full name of responsible person - Persian: دکتر فروه وکیلیان
Position - English: Associate Professor/Cardiologist
Position - Persian: دانشیار/متخصص قلب و عروق
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Cardiology, Imam Reza Hospital, Ibn Sina street
Street address - Persian: خیابان ابن سینا، بیمارستان امام رضا (ع)، بخش قلب و عروق
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 3854 3031
Mobile: +98 915 316 2670
Fax:
Email: vakilianf@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Cardiology, School of Medicine, Mashhad University of Medical Sciences
Name of organization / entity - Persian: گروه قلب و عروق، دانشکده پزشکی، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Farveh Vakilian
Full name of responsible person - Persian: دکتر فروه وکیلیان
Position - English: Associate Professor/Cardiologist
Position - Persian: دانشیار/متخصص قلب و عروق
Latest degree: specialist
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Cardiology, Imam Reza Hospital, Ibn Sina street
Street address - Persian: خیابان ابن سینا، بیمارستان امام رضا (ع)، بخش قلب و عروق
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 3854 3031
Mobile: +98 915 316 2670
Fax:
Email: vakilianf@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Cardiology, School of Medicine, Mashhad University of Medical Sciences Name of organization / entity - Persian: گروه قلب و عروق، دانشکده پزشکی، دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr. Farveh Vakilian Full name of responsible person - Persian: دکتر فروه وکیلیان Position - English: Associate Professor/Cardiologist Position - Persian: دانشیار/متخصص قلب و عروق Latest degree: specialist Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Cardiology, Imam Reza Hospital, Ibn Sina street Street address - Persian: خیابان ابن سینا، بیمارستان امام رضا (ع)، بخش قلب و عروق 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 3854 3031 Mobile: +98 915 316 2670 Fax: Email: vakilianf@mums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine,
Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: Clinical PhD, Assistant professor
Position - Persian: دکترای تخصصی بالینی/استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Traditional and Complementary Medicine, university campus, Azadi square
Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده طب سنتی و مکمل
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: +98 915 314 9363
Fax:
Email: Azizih@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine,
Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Hoda Azizi
Full name of responsible person - Persian: دکتر هدا عزیزی
Position - English: Clinical PhD, Assistant professor
Position - Persian: دکترای تخصصی بالینی/استادیار
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Traditional and Complementary Medicine, university campus, Azadi square
Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده طب سنتی 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 3855 2188
Mobile: +98 915 314 9363
Fax:
Email: Azizih@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine, Name of organization / entity - Persian: گروه طب چینی و مکمل، دانشکده طب سنتی و مکمل، دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr. Hoda Azizi Full name of responsible person - Persian: دکتر هدا عزیزی Position - English: Clinical PhD, Assistant professor Position - Persian: دکترای تخصصی بالینی/استادیار Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Traditional and Complementary Medicine, university campus, Azadi square Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده طب سنتی 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 3855 2188 Mobile: +98 915 314 9363 Fax: Email: Azizih@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: School of Medicine, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشکده پزشکی، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Farzaneh Norouzi
Full name of responsible person - Persian: دکتر فرزانه نوروزی
Position - English: Medical student
Position - Persian: دانشجوی پزشکی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Medicine, university campus, Azadi square
Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده پزشکی
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 3622 2163
Mobile: 00
Fax:
Email: Fnsb9190@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: School of Medicine, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشکده پزشکی، دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Farzaneh Norouzi
Full name of responsible person - Persian: دکتر فرزانه نوروزی
Position - English: Medical student
Position - Persian: دانشجوی پزشکی
Latest degree: med_doctor
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Medicine, university campus, Azadi square
Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده پزشکی
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 3622 2163
Mobile: 00
Fax:
Email: Fnsb9190@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: School of Medicine, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشکده پزشکی، دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr. Farzaneh Norouzi Full name of responsible person - Persian: دکتر فرزانه نوروزی Position - English: Medical student Position - Persian: دانشجوی پزشکی Latest degree: med_doctor Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Medicine, university campus, Azadi square Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده پزشکی 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 3622 2163 Mobile: 00 Fax: Email: Fnsb9190@gmail.com Web page address:
Sharing plan
no
no
no
no
no
no
no
no
no
no
no
no
no
no
empty
No more data is available.
No more data is available.
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
The purpose of this study is comparing the effect of adding acupuncture to medication with medication alone on cardiac and autonomic function in patients with heart failure.
Design
clinical trial with intervention and control group, single blind randomized trial with fleiss table, each groupncontain 36 member
Settings and conduct
heart failure clinic of Imam Reza Hospital, Mashhad
72 patients with class II and III heart failure and ejection fraction less than 40% will be entered into this study and will randomly be divided into two groups of intervention (acupuncture and medication) and control (medication alone).
In the intervention group, acupuncture will be performed three times a week.
The cardiologist and statistician will be blind to the assigned groups. The acupuncturist and patients will not be blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Patients older than 21 years of age with stable and compensated heart failure, class 2 and 3, and left ventricular ejection fraction less than or equal to 40% will be included.
Intervention groups
Two groups of intervention (acupuncture and medication) and control (medication alone)
Main outcome variables
electrocardiography, echocardiography, 6-minute walk test, heart rate and blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201706087265N8
Registration date:2017-09-22, 1396/06/31
Registration timing:prospective
Last update:2019-07-01, 1398/04/10
Update count:1
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupuncture and medication on cardiac and autonomic function in patients with heart failure
Public title
Effect of acupuncture on cardiac function and autonomic nervous system in heart failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age>= 21
Heart failure with reduced ejection fraction (LVEF ≤40%)
New York Heart Association class II-III
sinus rhythm
patient consent
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomized into intervention group (real acupuncture + medication) and control group (medication) by random allocation with Fleiss table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients were not blind. the cardiologist was blind about study groups but it was not possible about acupuncturist. the questioner was not blind but the analyzer was blind.
Placebo
Not used
Assignment
Parallel
Other design features
The list of random numbers will be provided for the two groups using the Fleiss table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qorashi building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MUMS.REC.1394.214
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Blood pressure
Timepoint
before study and at week 8
Method of measurement
Using sphygmomanometer
2
Description
Heart Rate
Timepoint
before study and at week 8
Method of measurement
Examination of pulse and counting the pulses per minute
3
Description
6 minute walk test
Timepoint
before study and at week 8
Method of measurement
Measuring the patient's walking distance on a specified path within 6 minutes.
4
Description
PR wave
Timepoint
before study and at week 8
Method of measurement
Time distance of PR wave in electrocardiogram (seconds)
5
Description
QRS wave
Timepoint
before study and at week 8
Method of measurement
Time distance of QRS wave in electrocardiogram (seconds)
6
Description
Ejection Fraction
Timepoint
before study and at week 8
Method of measurement
Percentage of cardiac ejection fraction in echocardiography
7
Description
Righ ventricular end diastolic diameter
Timepoint
before study and at week 8
Method of measurement
Righ ventricular end diastolic diameter in echocardiography (cm)
8
Description
left ventricular end diastolic diameter
Timepoint
before study and at week 8
Method of measurement
left ventricular end diastolic diameter in echocardiography (cm)
9
Description
Tricuspid annular plane systolic excursion
Timepoint
Before study and at week 8
Method of measurement
Measuring by echocardiography (mm)
10
Description
End Systolic Volume
Timepoint
before study and at week 8
Method of measurement
End Systolic Volume in echocardiography (ml)
11
Description
NYHA class
Timepoint
before study and at week 8
Method of measurement
The amount of activity that dyspnea occures according to the patient's history (a 4 points scale)
Secondary outcomes
1
Description
Quality of life
Timepoint
before study and at week 8
Method of measurement
The score of patient's quality of life according to SF36 questionnaire
Intervention groups
1
Description
Intervention group: 12 sessions of acupuncture (3 times per week) and medication
Category
Treatment - Other
2
Description
Control group: medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology clinic, Imam Reza Hospital
Full name of responsible person
Dr. Farveh Vakilian
Street address
Cardiology clinic, Imam Reza Hospital, Ibn Sina street, Mashhad
City
Mashhahd
Province
Razavi Khorasan
Postal code
9177948564
Email
vakilianf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
University Central building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Email
tafaghodim@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 of 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
Department of Cardiology, School of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farveh Vakilian
Position
Associate Professor/Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Street address
Department of Cardiology, Imam Reza Hospital, Ibn Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3854 3031
Fax
Email
vakilianf@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine,
Full name of responsible person
Dr. Hoda Azizi
Position
Clinical PhD, Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Traditional and Complementary Medicine, university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3855 2188
Fax
Email
Azizih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Norouzi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
School of Medicine, university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3622 2163
Fax
Email
Fnsb9190@gmail.com
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