Effects of lemon balm extract on glycemic criteria, lipid profile, apolipoprotein B, apolipoprotein A-1, antioxidant capacity and hs-CRP in comparison with control group in patients with type II diabetes
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Protocol summary
This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes. In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes reffering to the Institute of Endocrinology and Metabolism will be included. Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone. Patients will be randomly assigned to intervention or control groups. In intervention group, patients will receive capsules containing 350 mg Melissa officinalis extract twice per day for 3 months. While, patients at the control group will receive placebo capsules containing 350 mg toasted flour twice daily during 3 months.
All laboratory test including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , in addition blood pressure and anthropometric indices will be measured at baseline and week 12 of the study. Also, the dietary intakes and physical activity will be measured.
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This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes. In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes reffering to the Institute of Endocrinology and Metabolism will be included. Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone. Patients will be randomly assigned to intervention or control groups. In intervention group, patients will receive capsules containing 350 mg Melissa officinalis extract twice per day for 3 months. While, patients at the control group will receive placebo capsules containing 350 mg toasted flour twice daily during 3 months. All laboratory test including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , in addition blood pressure and anthropometric indices will be measured at baseline and week 12 of the study. Also, the dietary intakes and physical activity will be measured.
هدف این مطالعه بررسی اثرات عصاره گیاه بادرنجبویه بر شاخص های گلایسمی، پروفایل لیپیدی، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، ظرفیت تام آنتی اکسیدانی و hs-CRP در بیماران مبتلا به دیابت نوع دو می باشد. در اين کارآزمايي بالینی تصادفی شده (دو سویه کور)، 70 بيمار (در محدوده ی سنی 65-20 سال ) مبتلا به دیابت نوع 2 داوطلب مراجعه کننده به انستیتو غدد درون ریز و متابولیسم دانشگاه علوم پزشکی ایران، انتخاب خواهند شد. معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت (مت فورمین و گلی بنگلامین کلامید). معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی؛ قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی و بیماران مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی می باشند.
پس از تقسیم تصادفی به دو گروه مورد و شاهدی ، به مدت 3 ماه گروه مداخله عصاره هیدروالکلی بادرنجبویه هر روز دو کپسول mg 350 و گروه شاهد روزانه دو کپسول mg 350 دارونما ( آرد سوخاری ) دریافت خواهند کرد. غلظت ليپيدهاي سرم، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، وضعیت گلایسمی، hs-CRP، ظرفیت تام آنتی اکسیدانی و نیز فشارخون و شاخص هاي تن سنجي در ابتدا و انتهای مطالعه اندازه گیری و مورد تجزیه و تحلیل قرار خواهد گرفت. همچنین دريافت هاي غذايي و فعاليت فيزيکي نیز ارزیابی خواهند شد.
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هدف این مطالعه بررسی اثرات عصاره گیاه بادرنجبویه بر شاخص های گلایسمی، پروفایل لیپیدی، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، ظرفیت تام آنتی اکسیدانی و hs-CRP در بیماران مبتلا به دیابت نوع دو می باشد. در اين کارآزمايي بالینی تصادفی شده (دو سویه کور)، 70 بيمار (در محدوده ی سنی 65-20 سال ) مبتلا به دیابت نوع 2 داوطلب مراجعه کننده به انستیتو غدد درون ریز و متابولیسم دانشگاه علوم پزشکی ایران، انتخاب خواهند شد. معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت (مت فورمین و گلی بنگلامین کلامید). معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی؛ قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی و بیماران مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی می باشند. پس از تقسیم تصادفی به دو گروه مورد و شاهدی ، به مدت 3 ماه گروه مداخله عصاره هیدروالکلی بادرنجبویه هر روز دو کپسول mg 350 و گروه شاهد روزانه دو کپسول mg 350 دارونما ( آرد سوخاری ) دریافت خواهند کرد. غلظت ليپيدهاي سرم، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، وضعیت گلایسمی، hs-CRP، ظرفیت تام آنتی اکسیدانی و نیز فشارخون و شاخص هاي تن سنجي در ابتدا و انتهای مطالعه اندازه گیری و مورد تجزیه و تحلیل قرار خواهد گرفت. همچنین دريافت هاي غذايي و فعاليت فيزيکي نیز ارزیابی خواهند شد.
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This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes.
This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes.
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هدف این مطالعه بررسی اثرات عصاره گیاه بادرنجبویه بر شاخص های گلایسمی، پروفایل لیپیدی، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، ظرفیت تام آنتی اکسیدانی و hs-CRP در بیماران مبتلا به دیابت نوع دو می باشد.
هدف این مطالعه بررسی اثرات عصاره گیاه بادرنجبویه بر شاخص های گلایسمی، پروفایل لیپیدی، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، ظرفیت تام آنتی اکسیدانی و hs-CRP در بیماران مبتلا به دیابت نوع دو می باشد.
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Patients will be randomly assigned two groups. In the intervention group, patients will receive two capsules containing 350 mg Melissa officinalis extract per day for 3 months. patients in the control group will receive two capsules containing 350 mg toasted flour twice daily for 3 months.
Laboratory tests including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , also blood pressure and anthropometric indices will be measured at baseline and at the end study. Also, the dietary intakes and physical activity will be measured.
Patients will be randomly assigned two groups. In the intervention group, patients will receive two capsules containing 350 mg Melissa officinalis extract per day for 3 months. patients in the control group will receive two capsules containing 350 mg toasted flour twice daily for 3 months. Laboratory tests including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , also blood pressure and anthropometric indices will be measured at baseline and at the end study. Also, the dietary intakes and physical activity will be measured.
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پس از تقسیم تصادفی به دو گروه، گروه مداخله به مدت 3 ماه گروه مداخله عصاره هیدروالکلی بادرنجبویه هر روز دو کپسول mg 350 و گروه شاهد روزانه دو کپسول mg 350 دارونما ( آرد سوخاری ) دریافت خواهند کرد. غلظت ليپيدهاي سرم، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، وضعیت گلایسمی، hs-CRP، ظرفیت تام آنتی اکسیدانی و نیز فشارخون و شاخص هاي تن سنجي در ابتدا و انتهای مطالعه اندازه گیری و مورد تجزیه و تحلیل قرار خواهد گرفت. همچنین دريافت هاي غذايي و فعاليت فيزيکي نیز ارزیابی خواهند شد.
پس از تقسیم تصادفی به دو گروه، گروه مداخله به مدت 3 ماه گروه مداخله عصاره هیدروالکلی بادرنجبویه هر روز دو کپسول mg 350 و گروه شاهد روزانه دو کپسول mg 350 دارونما ( آرد سوخاری ) دریافت خواهند کرد. غلظت ليپيدهاي سرم، آپولیپوپروتئین B، آپولیپوپروتئین 1-A، وضعیت گلایسمی، hs-CRP، ظرفیت تام آنتی اکسیدانی و نیز فشارخون و شاخص هاي تن سنجي در ابتدا و انتهای مطالعه اندازه گیری و مورد تجزیه و تحلیل قرار خواهد گرفت. همچنین دريافت هاي غذايي و فعاليت فيزيکي نیز ارزیابی خواهند شد.
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In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes referring to the Iranian Diabetes Society and Institute of Endocrinology and Metabolism will be included.
In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes referring to the Iranian Diabetes Society and Institute of Endocrinology and Metabolism will be included.
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در اين کارآزمايي بالینی تصادفی شده (دو سویه کور)، 70 بيمار (در محدوده ی سنی 65-20 سال ) مبتلا به دیابت نوع 2 داوطلب مراجعه کننده به انجمن دیابت ایران و انستیتو غدد درون ریز و متابولیسم دانشگاه علوم پزشکی ایران، انتخاب خواهند شد.
در اين کارآزمايي بالینی تصادفی شده (دو سویه کور)، 70 بيمار (در محدوده ی سنی 65-20 سال ) مبتلا به دیابت نوع 2 داوطلب مراجعه کننده به انجمن دیابت ایران و انستیتو غدد درون ریز و متابولیسم دانشگاه علوم پزشکی ایران، انتخاب خواهند شد.
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Inclusion criteria are: Patients aged 20 to 65 years for both sexes; BMI less than 35 kg/m2; no pregnancy or lactation; TG less than 400 mg/dl; HbA1c < % 8; using oral hypoglycemic agents. Exclusion criteria are: possess of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking NSAIDS drugs or estrogen and progesterone.
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; BMI less than 35 kg/m2; no pregnancy or lactation; TG less than 400 mg/dl; HbA1c < % 8; using oral hypoglycemic agents. Exclusion criteria are: possess of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking NSAIDS drugs or estrogen and progesterone.
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معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت. معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی، قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی، مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی.
معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت. معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی، قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی، مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی.
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Intervention group: Taking orally 2 capsules of 350 mg Mellissa officinalis extract per day for 3 months. Capsules are provided in Institute of Medicinal Plants affiliated with ACECR.
Placebo group: Taking orally 2 similar capsules of toasted flour.
Intervention group: Taking orally 2 capsules of 350 mg Mellissa officinalis extract per day for 3 months. Capsules are provided in Institute of Medicinal Plants affiliated with ACECR. Placebo group: Taking orally 2 similar capsules of toasted flour.
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گروه مداخله: مصرف عصاره هیدروالکلی بادرنجبویه به صورت دو عدد کپسول 350 میلی گرمی بعد از وعده غذایی نهار و شام. کپسول ها توسط پژوهشكده گياهان دارويي جهاد دانشگاهي تهیه میشوند.
گروه دارونما: مصرف کپسول های مشابه با دوزاژ مشابه حاوی آرد سوخاری.
گروه مداخله: مصرف عصاره هیدروالکلی بادرنجبویه به صورت دو عدد کپسول 350 میلی گرمی بعد از وعده غذایی نهار و شام. کپسول ها توسط پژوهشكده گياهان دارويي جهاد دانشگاهي تهیه میشوند. گروه دارونما: مصرف کپسول های مشابه با دوزاژ مشابه حاوی آرد سوخاری.
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FBS, Fasting insulin, Total antioxidant capacity, Apo A-1, Apo B, HbA1c, TG, TC, HDL-C, LDL-C, hs-CRP, Insulin resistance (HOMA-IR)
FBS, Fasting insulin, Total antioxidant capacity, Apo A-1, Apo B, HbA1c, TG, TC, HDL-C, LDL-C, hs-CRP, Insulin resistance (HOMA-IR)
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone.
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone.
معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت (مت فورمین و گلی بنگلامین کلامید). معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی، قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی، مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی.
معیارهای ورود به مطالعه شامل: محدوده سنی 20 تا 65 سال در هر دو جنس؛ میزان نمایه توده بدن آنها کم تر از 35؛ باردار یا شیرده نبودن؛ تری گلیسیرید کمتر از 400؛ HbA1c < %8؛ مصرف داروهای رایج دیابت (مت فورمین و گلی بنگلامین کلامید). معیار های خروج از مطالعه شامل: بیماران مبتلا به اختلالات و بیماری های کلیوی، قلبی عروقی، کبدی، عفونی، تیروئیدی، آلرژی، مبتلا به گلوکوم (آب سیاه چشم)؛ مصرف داروهای ضدالتهاب غیراستروئیدی (NSAIDS)، استروژنی و پروژسترونی.
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The patients will be categorized in two groups by random allocation.
The patients will be categorized in two groups by random allocation.
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تصادفی سازی به صورت تصادفی به دو گروه انجام می پذیرد.
تصادفی سازی به صورت تصادفی به دو گروه انجام می پذیرد.
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The patients will be categorized into three groups by random allocation.
The patients will be categorized into three groups by random allocation.
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تصادفی سازی با استفاده از قرعه کشی انجام می پذیرد.
تصادفی سازی با استفاده از قرعه کشی انجام می پذیرد.
Recruitment centers
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Name of recruitment center - English: The Institute of Endocrinology and Metabolism Research (Iran University Of Medical Sciences)
Name of recruitment center - Persian: مرکز تحقیقات غدد و متابولیسم دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Iraj Heidary
Full name of responsible person - Persian: دکتر ایرج حیدری
Street address - English: Endocrine and Research Center-Firozgar Education Center-Behafarin Avenue-Valiasr Square
Street address - Persian: میدان ولیعصر-خیابان به آفرین -مرکز آموزشی فیروزگر-مرکز تحقیقات غدد و متابولیسم دانشگاه ایران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: The Institute of Endocrinology and Metabolism Research (Iran University Of Medical Sciences)
Name of recruitment center - Persian: مرکز تحقیقات غدد و متابولیسم دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Iraj Heidary
Full name of responsible person - Persian: دکتر ایرج حیدری
Street address - English: Endocrine and Research Center-Firozgar Education Center-Behafarin Avenue-Valiasr Square
Street address - Persian: میدان ولیعصر-خیابان به آفرین -مرکز آموزشی فیروزگر-مرکز تحقیقات غدد و متابولیسم دانشگاه ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 5977146377
Phone: +98 21 8862 2755
Fax:
Email: farzadshidfar@yahoo.com
Web page address:
Name of recruitment center - English: The Institute of Endocrinology and Metabolism Research (Iran University Of Medical Sciences) Name of recruitment center - Persian: مرکز تحقیقات غدد و متابولیسم دانشگاه علوم پزشکی ایران Full name of responsible person - English: Iraj Heidary Full name of responsible person - Persian: دکتر ایرج حیدری Street address - English: Endocrine and Research Center-Firozgar Education Center-Behafarin Avenue-Valiasr Square Street address - Persian: میدان ولیعصر-خیابان به آفرین -مرکز آموزشی فیروزگر-مرکز تحقیقات غدد و متابولیسم دانشگاه ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 5977146377 Phone: +98 21 8862 2755 Fax: Email: farzadshidfar@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research, Iran University Of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. Seyed Ali Javad Moosavi
Full name of responsible person - Persian: دکتر سید علی جواد موسوی
Street address - English: 7th Floor, Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St., Sattarkahn Ave, Tehran, Iran.
Street address - Persian: ایران، تهران، خیابان ستارخان، خیابان نیایش، بیمارستان حضرت رسول اکرم، دانشگاه علوم پزشکی ایران، گروه پزشکی داخلی، طبقه 7
City - English: Tehran
City - Persian: تهران
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, Iran University Of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. Seyed Ali Javad Moosavi
Full name of responsible person - Persian: دکتر سید علی جواد موسوی
Street address - English: 7th Floor, Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St., Sattarkahn Ave, Tehran, Iran.
Street address - Persian: ایران، تهران، خیابان ستارخان، خیابان نیایش، بیمارستان حضرت رسول اکرم، دانشگاه علوم پزشکی ایران، گروه پزشکی داخلی، طبقه 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 5977146377
Phone: +98 21 8862 2755
Fax:
Email: Dr_moosavi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for Research, Iran University Of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران Full name of responsible person - English: Dr. Seyed Ali Javad Moosavi Full name of responsible person - Persian: دکتر سید علی جواد موسوی Street address - English: 7th Floor, Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St., Sattarkahn Ave, Tehran, Iran. Street address - Persian: ایران، تهران، خیابان ستارخان، خیابان نیایش، بیمارستان حضرت رسول اکرم، دانشگاه علوم پزشکی ایران، گروه پزشکی داخلی، طبقه 7 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 5977146377 Phone: +98 21 8862 2755 Fax: Email: Dr_moosavi@yahoo.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Iran University Of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شیدفر
Position - English: Professor
Position - Persian: استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University Of Medical Science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8670 4711
Mobile: +98 912 308 2922
Fax:
Email: shidfar.f@iums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University Of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شیدفر
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University Of Medical Science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 59771346377
Phone: +98 21 8670 4711
Mobile: +98 912 308 2922
Fax:
Email: shidfar.f@iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University Of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Farzad Shidfar Full name of responsible person - Persian: دکتر فرزاد شیدفر Position - English: Professor Position - Persian: استاد Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Iran University Of Medical Science, Hemmat highway,Tehran,Iran Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 59771346377 Phone: +98 21 8670 4711 Mobile: +98 912 308 2922 Fax: Email: shidfar.f@iums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شیدفر
Position - English: Professor
Position - Persian: استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8670 4711
Mobile: +98 912 308 2922
Fax:
Email: shidfar.f@iums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Farzad Shidfar
Full name of responsible person - Persian: دکتر فرزاد شیدفر
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5977146377
Phone: +98 21 8670 4711
Mobile: +98 912 308 2922
Fax:
Email: shidfar.f@iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Farzad Shidfar Full name of responsible person - Persian: دکتر فرزاد شیدفر Position - English: Professor Position - Persian: استاد Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5977146377 Phone: +98 21 8670 4711 Mobile: +98 912 308 2922 Fax: Email: shidfar.f@iums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Iran University Of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Akbar Asadi
Full name of responsible person - Persian: اکبر اسدی
Position - English: MS.c student in Nutrition Science
Position - Persian: دانشجوی کارشناسی ارشد رشته ی علوم تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8862 2755
Mobile: +98 938 119 5824
Fax:
Email: a-m.asadi@tak.iums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University Of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Akbar Asadi
Full name of responsible person - Persian: اکبر اسدی
Position - English: MS.c student in Nutrition Science
Position - Persian: دانشجوی کارشناسی ارشد رشته ی علوم تغذیه
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran
Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5977146377
Phone: +98 21 8862 2755
Mobile: +98 938 119 5824
Fax:
Email: a-m.asadi@tak.iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University Of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Akbar Asadi Full name of responsible person - Persian: اکبر اسدی Position - English: MS.c student in Nutrition Science Position - Persian: دانشجوی کارشناسی ارشد رشته ی علوم تغذیه Latest degree: bachelor Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Iran University of medical science, Hemmat highway,Tehran,Iran Street address - Persian: تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5977146377 Phone: +98 21 8862 2755 Mobile: +98 938 119 5824 Fax: Email: a-m.asadi@tak.iums.ac.ir Web page address:
Sharing plan
undecided
undecided
no
no
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
undecided.
undecided.
empty
تصمیم نگرفته شده است.
تصمیم نگرفته شده است.
Protocol summary
Study aim
This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes.
Design
Patients will be randomly assigned two groups. In the intervention group, patients will receive two capsules containing 350 mg Melissa officinalis extract per day for 3 months. patients in the control group will receive two capsules containing 350 mg toasted flour twice daily for 3 months.
Laboratory tests including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , also blood pressure and anthropometric indices will be measured at baseline and at the end study. Also, the dietary intakes and physical activity will be measured.
Settings and conduct
In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes referring to the Iranian Diabetes Society and Institute of Endocrinology and Metabolism will be included.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; BMI less than 35 kg/m2; no pregnancy or lactation; TG less than 400 mg/dl; HbA1c < % 8; using oral hypoglycemic agents. Exclusion criteria are: possess of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking NSAIDS drugs or estrogen and progesterone.
Intervention groups
Intervention group: Taking orally 2 capsules of 350 mg Mellissa officinalis extract per day for 3 months. Capsules are provided in Institute of Medicinal Plants affiliated with ACECR.
Placebo group: Taking orally 2 similar capsules of toasted flour.
Main outcome variables
FBS, Fasting insulin, Total antioxidant capacity, Apo A-1, Apo B, HbA1c, TG, TC, HDL-C, LDL-C, hs-CRP, Insulin resistance (HOMA-IR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201701162709N41
Registration date:2017-05-17, 1396/02/27
Registration timing:prospective
Last update:2018-03-25, 1397/01/05
Update count:1
Registration date
2017-05-17, 1396/02/27
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University Of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
empty
Scientific title
Effects of lemon balm extract on glycemic criteria, lipid profile, apolipoprotein B, apolipoprotein A-1, antioxidant capacity and hs-CRP in comparison with control group in patients with type II diabetes
Public title
Effects of lemon balm extract on glycemic criteria, lipid profile, hs-CRP and antioxidant status in patients with type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone.
Exclusion criteria:
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be categorized in two groups by random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be categorized into three groups by random allocation.
Placebo
Used
Assignment
Parallel
Other design features
The patients will be categorized in three groups by random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University Of Medical Science, Hemmat highway,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.IUMS.REC 1395.9411468001
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Enzymatic method
2
Description
Fasting insulin
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
ELISA
3
Description
Total antioxidant capacity
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Colorimetry (FRAP)
4
Description
Apo A-1
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Immunoturbidimetry
5
Description
Apo B
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Immunoturbidimetry
6
Description
HbA1c
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
High Performance Liquid Chromatography
7
Description
TG
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Enzymatic method
8
Description
TC
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Enzymatic method
9
Description
HDL-C
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Enzymatic method
10
Description
LDL-C
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Friedewald formula
11
Description
hs-CRP
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
ELISA
12
Description
Insulin resistance (HOMA-IR)
Timepoint
before the experiment and 12 weeks after intervention
Method of measurement
Formula
Secondary outcomes
1
Description
BP
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Mercury sphygmomanometer
2
Description
Body mass index
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Weight (kg) /height2 (m2)
3
Description
Weight
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Seca scale
4
Description
Waist circumference
Timepoint
Before the experiment and 12 weeks after intervention
Method of measurement
Elastic tape
5
Description
Physical activity
Timepoint
Before intervention and 6 and 12 weeks after intervention
Method of measurement
International Physical Activity Questionarre
6
Description
Energy intake
Timepoint
Before intervention and 6 and 12 weeks after intervention
Method of measurement
24-hour dietary recall
Intervention groups
1
Description
Intervention group: Taking orally 2 herbal capsules of 350 mg mellissa officinalis extract per day ( one after Lunch and one after Dinner) for 3 months. Capsules are provided in Institute of Medicinal Plants affiliated with ACECR.
Category
Treatment - Drugs
2
Description
Placebo group: Taking orally 2 similar capsules of toasted flour per day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The Institute of Endocrinology and Metabolism Research (Iran University Of Medical Sciences)
Full name of responsible person
Iraj Heidary
Street address
Endocrine and Research Center-Firozgar Education Center-Behafarin Avenue-Valiasr Square
City
Tehran
Province
Tehran
Postal code
5977146377
Phone
+98 21 8862 2755
Email
farzadshidfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University Of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
7th Floor, Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St., Sattarkahn Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5977146377
Phone
+98 21 8862 2755
Email
Dr_moosavi@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, Iran 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
Iran University Of Medical Science
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University Of Medical Science, Hemmat highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
59771346377
Phone
+98 21 8670 4711
Fax
Email
shidfar.f@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of medical science, Hemmat highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
5977146377
Phone
+98 21 8670 4711
Fax
Email
shidfar.f@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University Of Medical Science
Full name of responsible person
Akbar Asadi
Position
MS.c student in Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Iran University of medical science, Hemmat highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
5977146377
Phone
+98 21 8862 2755
Fax
Email
a-m.asadi@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available