Investigation the effects of Arctium Lappa root powder on some markers of oxidative stress and inflammation in women with polycystic ovary syndrome: a randomized double blind clinical trial study
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Protocol summary
The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients will not be aware of the type of drug and the statistician will not be aware of the type of groups.
The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients and specialist will not be aware of the type of groups.
The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients will not be aware of the type of drug and the statisticianspecialist will not be aware of the type of groups.
هدف از مطالعه و نحوه انجام آن به بیماران توضیح داده خواهد شد و رضایت نامه کتبی جهت شرکت در مطالعه، در بیمارستان طالقانی اراک از آنها اخذ خواهد شد. در ابتدای مطالعه از بیماران نمونه خون گرفته می شود (نمونه گیری در کلینیک صورت می گیرد) و فاکتورهایی نظیر چربی خون و غیره اندازه گیری می شوند (اندازه گیری فاکتورها در آزمایشگاه دانشگاه علوم پزشکی اراک صورت می گیرد). سپس داروی گیاهی در افراد شرکت کننده در مطالعه به مدت 12هفته مورد استفاده قرار گرفته و پس از این مدت نیز مجددا خونگیری و اندازه گیری فاکتورها به منظور ارزیابی میزان تاثیر دارو انجام خواهد شد. بیماران از نوع داروی مصرفی و متخصص آمار از گروه بندی انجام شده اطلاع نخواهند داشت.
هدف از مطالعه و نحوه انجام آن به بیماران توضیح داده خواهد شد و رضایت نامه کتبی جهت شرکت در مطالعه، در بیمارستان طالقانی اراک از آنها اخذ خواهد شد. در ابتدای مطالعه از بیماران نمونه خون گرفته می شود (نمونه گیری در کلینیک صورت می گیرد) و فاکتورهایی نظیر چربی خون و غیره اندازه گیری می شوند (اندازه گیری فاکتورها در آزمایشگاه دانشگاه علوم پزشکی اراک صورت می گیرد). سپس داروی گیاهی در افراد شرکت کننده در مطالعه به مدت 12هفته مورد استفاده قرار گرفته و پس از این مدت نیز مجددا خونگیری و اندازه گیری فاکتورها به منظور ارزیابی میزان تاثیر دارو انجام خواهد شد. بیماران و پزشک متخصص از گروه بندی انجام شده اطلاع نخواهند داشت.
هدف از مطالعه و نحوه انجام آن به بیماران توضیح داده خواهد شد و رضایت نامه کتبی جهت شرکت در مطالعه، در بیمارستان طالقانی اراک از آنها اخذ خواهد شد. در ابتدای مطالعه از بیماران نمونه خون گرفته می شود (نمونه گیری در کلینیک صورت می گیرد) و فاکتورهایی نظیر چربی خون و غیره اندازه گیری می شوند (اندازه گیری فاکتورها در آزمایشگاه دانشگاه علوم پزشکی اراک صورت می گیرد). سپس داروی گیاهی در افراد شرکت کننده در مطالعه به مدت 12هفته مورد استفاده قرار گرفته و پس از این مدت نیز مجددا خونگیری و اندازه گیری فاکتورها به منظور ارزیابی میزان تاثیر دارو انجام خواهد شد. بیماران از نوع داروی مصرفی و پزشک متخصص آمار از گروه بندی انجام شده اطلاع نخواهند داشت.
women in the age range of 18-45 years;whose PCOS has been confirmed by a specialist doctor;Only patients who do not intend to become pregnant are allowed to enter our study because the profile of therapeutic drugs of people who intend to become pregnant is different from those who do not intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.
women in the age range of 18-45 years;whose PCOS has been confirmed by a specialist based on Rotterdam criteria;Only patients who do not intend to become pregnant are allowed to enter our study because the profile of therapeutic drugs of them is different from those who intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.
women in the age range of 18-45 years;whose PCOS has been confirmed by a specialist doctorbased on Rotterdam criteria;Only patients who do not intend to become pregnant are allowed to enter our study because the profile of therapeutic drugs of people who intend to become pregnantthem is different from those who do not intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.
زنان در محدوده ی سنی 45-18 سال که ابتلای آنها به PCOS توسط پزشک متخصص تایید شده است؛ فقط بیمارانی اجازه ی ورود به مطالعه ی ما را دارند که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی افرادی که قصد بارداری دارند با افرادی که قصد بارداری ندارند متفاوت است.
معیار های عدم ورود عبارت اند از: مصرف داروهای ضد انعقادی و مکمل های آنتی اکسیدانی و ضد التهابی به فاصله‌ی 3 ماه قبل از مطالعه؛ ابتلای فرد به دیابت؛ اختلالات تیروئید و هایپرپرولاکتینمی.
زنان در محدوده ی سنی 45-18 سال که ابتلای آنها به PCOS توسط متخصص بر اساس معیار روتردام تایید شده است؛ فقط بیمارانی اجازه ی ورود به مطالعه ی ما را دارند که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی آنها با افرادی که قصد بارداری دارند متفاوت است.
معیار های عدم ورود عبارت اند از: مصرف داروهای ضد انعقادی و مکمل های آنتی اکسیدانی و ضد التهابی به فاصله‌ی 3 ماه قبل از مطالعه؛ ابتلای فرد به دیابت؛ اختلالات تیروئید و هایپرپرولاکتینمی.
زنان در محدوده ی سنی 45-18 سال که ابتلای آنها به PCOS توسط پزشک متخصص بر اساس معیار روتردام تایید شده است؛ فقط بیمارانی اجازه ی ورود به مطالعه ی ما را دارند که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی افرادی که قصد بارداری دارندآنها با افرادی که قصد بارداری ندارنددارند متفاوت است. معیار های عدم ورود عبارت اند از: مصرف داروهای ضد انعقادی و مکمل های آنتی اکسیدانی و ضد التهابی به فاصله‌ی 3 ماه قبل از مطالعه؛ ابتلای فرد به دیابت؛ اختلالات تیروئید و هایپرپرولاکتینمی.
General information
1
1
Adding a new ethics committee reference number for the research plan defined on this clinical trial and adding the factors to be measured in this plan(TNF-α, IL6 and AMH).
Additional clarification and rectification of these items: Inclusion criteria (adding Rotterdam criteria), blinding method description, timepoint of measurement, and also measurement method of the variable "menstrual frequency".
Adding a new ethics committee reference number forAdditional clarification and rectification of these items: Inclusion criteria (adding Rotterdam criteria), blinding method description, timepoint of measurement, and also measurement method of the research plan defined on this clinical trial and adding the factors to be measured in this plan(TNF-α, IL6 and AMH)variable "menstrual frequency".
افزودن کد کمیته اخلاق جدید جهت طرح تحقیقاتی تعریف شده بر روی این کارآزمایی بالینی و افزودن فاکتور های مورد سنجش در این طرح(IL6، TNF-α و AMH).
توضیح بیشتر و اصلاح این بخش ها: معیار ورود (افزودن معیار روتردام)، توصیف نحوه کور سازی، مقاطع زمانی اندازه گیری و همچنین نحوه اندازه گیری متغیر "فرکانس قاعدگی".
افزودن کد کمیته اخلاق جدید جهت طرح تحقیقاتی تعریف شده بر رویتوضیح بیشتر و اصلاح این کارآزمایی بالینیبخش ها: معیار ورود (افزودن معیار روتردام)، توصیف نحوه کور سازی، مقاطع زمانی اندازه گیری و افزودن فاکتور های مورد سنجش در این طرح(IL6، TNF-α و AMH)همچنین نحوه اندازه گیری متغیر "فرکانس قاعدگی".
Women in the age range of 18-45 years
Confirmation of PCOS by a specialist doctor
Patient satisfaction to enter the study
Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant
Women in the age range of 18-45 years
Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria
Patient satisfaction to enter the study
Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant
Women in the age range of 18-45 years Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria Patient satisfaction to enter the study Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant
زنان در محدوده ی سنی 45-18 سال
تایید ابتلا به PCOS توسط پزشک متخصص
رضایت بیماران جهت ورود به مطالعه
بیمارانی که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی افرادی که قصد بارداری دارند با افرادی که قصد بارداری ندارند متفاوت است
زنان در محدوده ی سنی 45-18 سال
تایید ابتلا به PCOS توسط پزشک متخصص بر اساس معیار روتردام
رضایت بیماران جهت ورود به مطالعه
بیمارانی که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی افرادی که قصد بارداری دارند با افرادی که قصد بارداری ندارند متفاوت است
زنان در محدوده ی سنی 45-18 سال تایید ابتلا به PCOS توسط پزشک متخصص بر اساس معیار روتردام رضایت بیماران جهت ورود به مطالعه بیمارانی که قصد بارداری نداشته باشند زیرا پروفایل داروهای درمانی افرادی که قصد بارداری دارند با افرادی که قصد بارداری ندارند متفاوت است
Participants, healthcare providers, and outcome assessors are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive. The statistician will not be informed about the grouping done.
Participants and healthcare providers are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive.
Participants, and healthcare providers, and outcome assessors are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive. The statistician will not be informed about the grouping done.
شرکت کنندگان، پرسنل بهداشتی درمانی و افرادی که پیامد را ارزیابی می کنند کور نگه داشته می شوند. دارو و دارو نما در بسته های مشابه بسته بندی می شوند. گروه درمان و گروه دارو نما از نوع مداخله ای که دریافت می کنند مطلع نخواهند بود. متخصص آمار نیز از گروه بندی انجام شده مطلع نخواهد بود.
شرکت کنندگان و پرسنل بهداشتی درمانی کور نگه داشته می شوند. دارو و دارو نما در بسته های مشابه بسته بندی می شوند. گروه درمان و گروه دارو نما از نوع مداخله ای که دریافت می کنند مطلع نخواهند بود.
شرکت کنندگان، و پرسنل بهداشتی درمانی و افرادی که پیامد را ارزیابی می کنند کور نگه داشته می شوند. دارو و دارو نما در بسته های مشابه بسته بندی می شوند. گروه درمان و گروه دارو نما از نوع مداخله ای که دریافت می کنند مطلع نخواهند بود. متخصص آمار نیز از گروه بندی انجام شده مطلع نخواهد بود.
Primary outcomes
#1
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#2
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#3
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#4
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#5
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#6
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#7
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#8
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#9
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#10
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#11
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#12
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#13
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#14
High-sensitivity C-reactive protein
C-reactive protein
High-sensitivity C-reactive protein
پروتئین واکنشی C با حساسیت بالا
پروتئین واکنشی C
پروتئین واکنشی C با حساسیت بالا
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
Immunoturbidimetry
Turbidimetry
ImmunoturbidimetryTurbidimetry
ایمونوتوربیدیمتری
توربیدیمتری
ایمونوتوربیدیمتریتوربیدیمتری
#15
The ratio of high-sensitivity C-reactive protein to albumin
The ratio of C-reactive protein to albumin
The ratio of high-sensitivity C-reactive protein to albumin
نسبت پروتئین واکنشی C با حساسیت بالا به آلبومین
نسبت پروتئین واکنشی C به آلبومین
نسبت پروتئین واکنشی C با حساسیت بالا به آلبومین
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#16
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#17
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#18
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#19
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#20
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
Ferriman-Gallwey scoring scale
Modified Ferriman-Gallwey scoring scale
Modified Ferriman-Gallwey scoring scale
مقیاس نمره دهی فریمن-گالوی
مقیاس نمره دهی فریمن-گالوی تعدیل شده
مقیاس نمره دهی فریمن-گالوی تعدیل شده
#21
Number of periods
Menstrual frequency
Number of periodsMenstrual frequency
تعداد قاعدگی
فرکانس قاعدگی
تعدادفرکانس قاعدگی
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
To ask the patient
To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).
To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).
پرسش از بیمار
پرسش از بیمار و تقسیم تعداد قاعدگی اتفاق افتاده در سه ماه بر تعداد قاعدگی مورد انتظار ( سه بار در سه ماه)
پرسش از بیمار و تقسیم تعداد قاعدگی اتفاق افتاده در سه ماه بر تعداد قاعدگی مورد انتظار ( سه بار در سه ماه)
#22
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Before and after 12 weeks after the start of the intervention(measuring on 40 patients)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته پس از شروع مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعدپس از شروع مداخله(سنجش بر روی 40 بیمار)
#23
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Before and after 12 weeks after the start of the intervention(measuring on 40 patients)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته پس از شروع مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعدپس از شروع مداخله(سنجش بر روی 40 بیمار)
#24
Before and after 12 weeks of intervention(measuring on 40 patients)
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Before and after 12 weeks after the start of the intervention(measuring on 40 patients)
قبل از مداخله و 12 هفته بعد از مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته پس از شروع مداخله(سنجش بر روی 40 بیمار)
قبل از مداخله و 12 هفته بعدپس از شروع مداخله(سنجش بر روی 40 بیمار)
#25
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#26
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#27
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#28
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#29
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#30
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
#31
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
Secondary outcomes
#1
Before and after 12 weeks of intervention
Before and 12 weeks after the start of the intervention
Before and after 12 weeks after the start of the intervention
قبل از مداخله و 12 هفته بعد از مداخله
قبل از مداخله و 12 هفته پس از شروع مداخله
قبل از مداخله و 12 هفته بعدپس از شروع مداخله
Protocol summary
Study aim
Effects of Arctium Lappa root on serum levels of some biochemical variables in women with polycystic ovary syndrome
Design
In this randomized, double-blind, phase 2 study, a total number of 60 people with polycystic ovary syndrome will be selected. They will be divided into two groups of Arctium Lappa root and placebo by block randomization method. They will be matched in age and BMI.
Settings and conduct
The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients and specialist will not be aware of the type of groups.
Participants/Inclusion and exclusion criteria
women in the age range of 18-45 years;whose PCOS has been confirmed by a specialist based on Rotterdam criteria;Only patients who do not intend to become pregnant are allowed to enter our study because the profile of therapeutic drugs of them is different from those who intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.
Intervention groups
Recipient group of Arctium Lappa root(One 460 mg capsule per day)and recipient group contains starch with the same dose.
Main outcome variables
Markers of oxidative stress and inflammation
General information
Reason for update
Additional clarification and rectification of these items: Inclusion criteria (adding Rotterdam criteria), blinding method description, timepoint of measurement, and also measurement method of the variable "menstrual frequency".
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057492N1
Registration date:2023-03-29, 1402/01/09
Registration timing:prospective
Last update:2025-02-09, 1403/11/21
Update count:4
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Hanieh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8278
Email address
hanieh.taheri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
2023-04-04, 1402/01/15
Actual recruitment end date
2024-01-20, 1402/10/30
Trial completion date
empty
Scientific title
Investigation the effects of Arctium Lappa root powder on some markers of oxidative stress and inflammation in women with polycystic ovary syndrome: a randomized double blind clinical trial study
Public title
Investigation the effects of Arctium Lappa root powder in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age range of 18-45 years
Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria
Patient satisfaction to enter the study
Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant
Exclusion criteria:
Smoking
consumption of anticoagulant drugs and antioxidant and anti-inflammatory supplements for 3 months before the study.
Pregnancy
Breastfeeding
Diabetes
Thyroid disorders
Hyperprolactinemia
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method will be used and the patients are placed in the intervention or control group using the block random allocation method with blocks of four. By assigning the letter A to the intervention group and the letter B to the control group, six states AABB, BBAA, BABA, ABBA, BAAB, and ABAB are written on separate sheets and are thrown into a container, and each time one of the sheets is taken out and it's written composition is noted and the sheet is thrown into the container again. Since the sample size in this study is 60, this procedure is repeated 15 times and each time the combination written on each sheet is noted in the sequence of the previous sheet. Then, a number from one to sixty is assigned to each of the letters in the order of the letters noted one after the other, and each of the letters are placed in an envelope and the specific number of each letter is written on the envelope. Every time which a subject is selected, one of the envelopes is opened. According to the number written on the envelope, the patient is introduced into the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and healthcare providers are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.ARAKMU.REC.1401.334
2
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.ARAKMU.REC.1403.060
3
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-10-06, 1403/07/15
Ethics committee reference number
IR.ARAKMU.REC.1403.224
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Superoxide dismutase
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
2
Description
Catalase
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
3
Description
Glutathione peroxidase
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
4
Description
Reduced glutathione
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
5
Description
Oxidized glutathione
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
6
Description
The ratio of reduced glutathione to oxidized glutathione
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
7
Description
Total antioxidant capacity
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
8
Description
Total oxidant status
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
9
Description
Oxidative stress index
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
10
Description
Malondialdehyde
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
11
Description
Ratio of malondialdehyde to total antioxidant capacity
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
12
Description
Total antioxidant gap
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
13
Description
Total Thiol
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
14
Description
C-reactive protein
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Turbidimetry
15
Description
The ratio of C-reactive protein to albumin
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
16
Description
The ratio of blood urea nitrogen to albumin
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
17
Description
Albumin bilirubin score
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
18
Description
Triglyceride-Glucose index
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
19
Description
Ovary volume
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Ultrasonography
20
Description
The rate of hirsutism
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Modified Ferriman-Gallwey scoring scale
21
Description
Menstrual frequency
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).
22
Description
Tumor necrosis factor-alpha
Timepoint
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Method of measurement
ELISA
23
Description
Interleukin-6
Timepoint
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Method of measurement
ELISA
24
Description
Anti-Mullerian Hormone
Timepoint
Before and 12 weeks after the start of the intervention(measuring on 40 patients)
Method of measurement
ELISA
25
Description
Triglyceride
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
26
Description
Cholesterol
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
27
Description
High Density Lipoprotein
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
28
Description
low Density Lipoprotein
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Colorimetric
29
Description
Cholesterol to high density lipoprotein ratio
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
30
Description
Triglyceride to high density lipoprotein ratio
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
31
Description
The ratio of low-density lipoprotein to high-density lipoprotein
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
Secondary outcomes
1
Description
Body mass index
Timepoint
Before and 12 weeks after the start of the intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: One capsule Arctium Lappa root powder (460 mg) per day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: One capsule placebo starch (460 mg) per day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Hanieh Taheri
Street address
Imam Khomeini Street, Shora Square, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 4001
Email
haniehtaheri1997@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3638
Email
Research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hanieh Taheri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
haniehtaheri1997@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanieh Taheri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
haniehtaheri1997@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanieh Taheri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
haniehtaheri1997@yahoo.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
Only results of main outcomes
When the data will become available and for how long
Six months after publishing of the results
To whom data/document is available
Only for academic staffs and universities researches
Under which criteria data/document could be used
Only for international and between universities researches
From where data/document is obtainable
Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir
What processes are involved for a request to access data/document
1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial.