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Melatonin administered postoperatively lowers oxidative stress and inflammation and significantly recovers heart function in patients undergoing CABG Surgery

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History
# Registration date Revision Id
2 2025-02-13, 1403/11/25 330918
1 2023-08-01, 1402/05/10 273696
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  • Protocol summary

    Patients undergoing CABG surgery at Bushehr Heart Center after discharge from the hospital will complete the consent form and questionnaire. Then 10cc blood sample will be collected from them after consuming melatonin and a placebo for a period of 30 days period of intervention. The project manager, the only person who knows about the codes and the order of assigning people to groups, is not involved in any of the stages of evaluating and measuring the results. On the other hand, the shape, size, and type of packaging of drugs and placebo are completely the same, so the patient and the outcome assessor will not know the type of intervention.
    Patients undergoing CABG surgery at Bushehr Heart Center after discharge from the hospital will complete the consent form and questionnaire. Then 10cc blood sample will be collected from them after consuming melatonin and a placebo for a period of 60 days period of intervention. The project manager, the only person who knows about the codes and the order of assigning people to groups, is not involved in any of the stages of evaluating and measuring the results. On the other hand, the shape, size, and type of packaging of drugs and placebo are completely the same, so the patient and the outcome assessor will not know the type of intervention.
    بیماران تحت عمل جراحی CABG در مرکز قلب بوشهر پس از ترخیص از بیمارستان فرم رضایت نامه و پرسشنامه کامل نموده، سپس ۱۰ سی سی نمونه خون از بیماران گرفته خواهد شد. بسته های ملاتونین و پلاسبو که بر اساس کدهای تصادفي تولید شده توسط كامپيوتر، لیبل یا برچسب شده اند تحویل خواهند گرفت. بعد از دوره مصرف 30 روزه مداخله مجدد 10 سی سی خون از بیماران گرفته خواهد شد. مدير پروژه، تنها كسي که از کدها و ترتیب تخصیص افراد به گروهها اطلاع دارد، در هیچ یک از مراحل ارزیابی و اندازه گیری پیامدها وارد نمی شود. از طرفي شکل، اندازه و نوع بسته بندی داروها و دارونما کاملاً یکسان است بنابراین بیمار و ارزیابگر پیامدها از نوع مداخله اطلاعی نخواهد داشت.
    بیماران تحت عمل جراحی CABG در مرکز قلب بوشهر پس از ترخیص از بیمارستان فرم رضایت نامه و پرسشنامه کامل نموده، سپس ۱۰ سی سی نمونه خون از بیماران گرفته خواهد شد. بسته های ملاتونین و پلاسبو که بر اساس کدهای تصادفي تولید شده توسط كامپيوتر، لیبل یا برچسب شده اند تحویل خواهند گرفت. بعد از دوره مصرف 60 روزه مداخله مجدد 10 سی سی خون از بیماران گرفته خواهد شد. مدير پروژه، تنها كسي که از کدها و ترتیب تخصیص افراد به گروهها اطلاع دارد، در هیچ یک از مراحل ارزیابی و اندازه گیری پیامدها وارد نمی شود. از طرفي شکل، اندازه و نوع بسته بندی داروها و دارونما کاملاً یکسان است بنابراین بیمار و ارزیابگر پیامدها از نوع مداخله اطلاعی نخواهد داشت.
    The case group will be given melatonin (5 mg and 10 mg capsules, once a night for 30 days). The control group will be without melatonin
    The case group will be given melatonin (5 mg and 10 mg capsules, once a night for 60 days). The control group will be without melatonin
    به گروه های مورد ملاتونین (کپسول 5 میلی گرمی و 10 میلی گرمی، یک بار در شب و به مدت 30 روز ) داده خواهد شد. گروه کنترل بدون ملاتونین خواهد بود
    به گروه های مورد ملاتونین (کپسول 5 میلی گرمی و 10 میلی گرمی، یک بار در شب و به مدت 60 روز ) داده خواهد شد. گروه کنترل بدون ملاتونین خواهد بود

  • General information

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    2024-02-12, 1402/11/23
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    2024-06-19, 1403/03/30
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    Title updated to be more appropriate Randomization method has been modified
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    عنوان به شیوه ای مناسب تر بروزرسانی شد نحوه تصادفی سازی اصلاح شد
    Evaluation of effects of melatonin on heart function and inflammatory and oxidant biomarkers in patients after coronary artery bypass grafting surgery
    Melatonin administered postoperatively lowers oxidative stress and inflammation and significantly recovers heart function in patients undergoing CABG Surgery
    بررسی اثرات ملاتونین بر عملکرد قلب و بیومارکرهای التهابی و اکسیدانی در بیماران پس از جراحی پیوند عروق کرونر قلب
    ملاتونین پس از عمل CABG، استرس اکسیداتیو و التهاب را کاهش داده و عملکرد قلب را بهبود می‌بخشد
    The random allocation method in this study will be permutated block randomization, where T represents the person receiving the intervention and C represents the person who receive the Placebo. This method is performed by considering blocks of sizes 4 patients so that the total number of 4 permutations is equal to 6 blocks as follows: (C,C,T,T), (T,T,C,C), (C,T,T,C), (C,T,C,T), (T,C,C,T), (T,C,T,C), (C,T,C,T) Then, a number of 15 blocks will be randomly selected with replacement from these 6 blocks. Finally, the desired list of 15 blocks of 4 (4 * 15 = 60 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. These steps are performed using R software version 3.6.3
    The random allocation method in this study will be permutated block randomization, where A and B represent the two intervention groups and C represents the control group. This method is performed by considering blocks of size 3 patients, so that the total number of 6 permutations is as follows: (A, B, C), (A, C, B), (B, A, C), (B, C, A), (C, A, B), (C, B, A). then, a number of 20 blocks will be randomly selected with replacement from these 6 block types. Finally, the desired list of 20 blocks of 3 (3 × 20 = 60 total number of samples) is generated, and the order of assignment to each of the samples participating in the study is determined. These steps are performed using computerized sequence-numbered codes that are given to the subjects in opaque envelopes at their first visit. Both the clinical team and participants are blinded from the time of randomization until the analysis is completed.
    روش تخصیص تصادفی در این مطالعه، روش بلوکی جایگشتی خواهد بود که T نشان دهنده فرد دریافت کننده مداخله و C نشان دهنده فردی است که پلاسبو دریافت می کند. این روش با در نظر گرفتن بلوک های 4تايي انجام می شود به طوری که تعداد کل 4 جایگشت به صورت 6 بلوك زیر مي باشد: (C،C،T،T)، (T،T،C،C)، (C،T،T،C)، (C،T،C،T)، (T،C،C،T)، (T,C,T,C), (C,T,C,T) سپس از بين اين 6 بلوك، تعداد 15 بلوک به صورت تصادفی با جايگذاري انتخاب می شود. در نهایت لیست مورد نظر شامل 15 بلوک 4 تایی (4⨯15 = 60 تعداد کل نمونه) تولید و ترتیب انتساب به هر یک از نمونه های شرکت کننده در مطالعه مشخص می شود. این مراحل با استفاده از نرم افزار R نسخه 3.6.3 انجام می شود.
    روش تخصیص تصادفی در این مطالعه به‌صورت تصادفی‌سازی بلوکی جایگشتی (permutated block randomization) انجام می‌شود، که در آن A و B نشان‌دهنده دو گروه مداخله و C نشان‌دهنده گروه کنترل است. این روش با در نظر گرفتن بلوک‌هایی با اندازه ۳ بیمار انجام می‌شود، به‌طوری‌که در مجموع ۶ جایگشت ممکن وجود دارد: (A, B, C)، (A, C, B)، (B, A, C)، (B, C, A)، (C, A, B)، (C, B, A). سپس، ۲۰ بلوک از میان این ۶ نوع بلوک، به‌صورت تصادفی با جایگذاری انتخاب می‌شود. در نهایت، لیست مورد نظر شامل ۲۰ بلوک ۳تایی (در مجموع ۶۰ نمونه) تولید شده و ترتیب تخصیص هر یک از نمونه‌های شرکت‌کننده در مطالعه تعیین می‌شود. این مراحل با استفاده از کدهای شماره‌گذاری‌شده متوالی که از طریق سیستم کامپیوتری تولید می‌شوند، انجام شده و این کدها در پاکت‌های مهر و موم‌شده در اولین مراجعه به شرکت‌کنندگان ارائه می‌شوند. همچنین، تیم بالینی و شرکت‌کنندگان تا زمان تکمیل تحلیل، از فرآیند تخصیص تصادفی بی‌اطلاع (کور) خواهند بود
    First, all melatonin and placebo capsules are prepared in the same shape and size and in packs of 20 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention.
    First, all melatonin and placebo capsules are prepared in the same shape and size and in packs of 60 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention.
    ابتدا کلیه کپسول های ملاتونین و دارونما در شکل و اندازه یکسان و در در بسته های 20 عددی براي توزيع به بيماران تهیه می شود. سپس بسته های دارو و پلاسبو بر اساس کدهای تصادفي تولید شده توسط كامپيوتر، لیبل یا برچسب مربوطه می گیرند (بدون ذكر محتواي آن). هريك از این کدها بر اساس توالی تخصیص تصادفی سازی افراد به گروهها تعيين مي شود. مدير پروژه، تنها كسي که از کدها و ترتیب تخصیص افراد به گروهها اطلاع دارد، در هیچ یک از مراحل ارزیابی و اندازه گیری پیامدها وارد نمی شود. از طرفي شکل، اندازه و نوع بسته بندی داروها و دارونما کاملاً یکسان است بنابراین بیمار و ارزیابگر پیامدها از نوع مداخله اطلاعی نخواهد داشت.
    ابتدا کلیه کپسول های ملاتونین و دارونما در شکل و اندازه یکسان و در در بسته های 60 عددی براي توزيع به بيماران تهیه می شود. سپس بسته های دارو و پلاسبو بر اساس کدهای تصادفي تولید شده توسط كامپيوتر، لیبل یا برچسب مربوطه می گیرند (بدون ذكر محتواي آن). هريك از این کدها بر اساس توالی تخصیص تصادفی سازی افراد به گروهها تعيين مي شود. مدير پروژه، تنها كسي که از کدها و ترتیب تخصیص افراد به گروهها اطلاع دارد، در هیچ یک از مراحل ارزیابی و اندازه گیری پیامدها وارد نمی شود. از طرفي شکل، اندازه و نوع بسته بندی داروها و دارونما کاملاً یکسان است بنابراین بیمار و ارزیابگر پیامدها از نوع مداخله اطلاعی نخواهد داشت.

  • Primary outcomes

    #1
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #2
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #3
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 12 تا 24 ساعت پس از دوره 60 روزه مصرف ملاتونین
    By sphygmomanometer, Mercury Type( Company: Microlife)
    By sphygmomanometer, Mercury Type (Company: Microlife)
    #4
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #5
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60روزه مصرف ملاتونین
    #6
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #7
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #8
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #9
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #10
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #11
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (30 days).
    Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین

  • Secondary outcomes

    #1
    Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 30 days of melatonin consumption
    Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #2
    Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 30 days of melatonin consumption
    Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #3
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days) .
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days) .
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #4
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #5
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #6
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #7
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #8
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین
    #9
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(30 days).
    Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 30 روزه مصرف ملاتونین
    حدود 24 ساعت قبل از شروع مصرف ملاتونین و 24 تا 72 ساعت پس از دوره 60 روزه مصرف ملاتونین

  • Intervention groups

    #1
    Control group: The placebo group (250 mg neutral micro cellulose capsules) will be given half an hour before sleep, and all the tests including heart function, and blood sampling, will be exactly like the melatonin intervention group. It will be done before and after the study.
    Control group: The placebo group (250 mg neutral micro cellulose capsules) will be given half an hour before sleep, and all the tests including heart function, and blood sampling, will be exactly like the melatonin intervention group. It will be done before and after the study.
    #2
    Intervention group: Melatonin (5 mg capsule) will be given once a night for half an hour before going to sleep, for 30 days.
    Intervention group: Melatonin (5 mg capsule) will be given once a night for half an hour before going to sleep, for 60 days.
    گروه مداخله: گروه اول : به این گروه ملاتونین (کپسول 5 میلی گرمی) یک بار در شب نیم ساعت قبل خواب، به مدت 30 روز داده خواهد شد
    گروه مداخله: گروه اول : به این گروه ملاتونین (کپسول 5 میلی گرمی) یک بار در شب نیم ساعت قبل خواب، به مدت 60 روز داده خواهد شد
    #3
    Intervention group: This group will be given melatonin (10 mg capsules) once a night for half an hour before going to sleep for 30 days.
    Intervention group: This group will be given melatonin (10 mg capsules) once a night for half an hour before going to sleep for 60 days.
    گروه مداخله: گروه دوم: به این گروه ملاتونین (کپسول 10 میلی گرمی) یک بار در شب نیم ساعت قبل خواب، به مدت 30 روز داده خواهد شد
    گروه مداخله: گروه دوم: به این گروه ملاتونین (کپسول 10 میلی گرمی) یک بار در شب نیم ساعت قبل خواب، به مدت 60 روز داده خواهد شد

  • Recruitment centers

    #1
    Name of recruitment center - English: Bushehr Heart Center
    Name of recruitment center - Persian: مرکز قلب بوشهر
    Full name of responsible person - English: Ali Movahed
    Full name of responsible person - Persian: علی موجد
    Street address - English: Moallem ST, School of Medicine, Biochemistry Laboratory, Bushehr, Iran
    Street address - Persian: بوشهر، خیابان معلم، دانشکده پزشکی، آزمایشگاه بیوشیمی
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 7514633341
    Phone: +98 917 371 1063
    Fax:
    Email: amovahed58@gmail.com
    Web page address:
    Name of recruitment center - English: Bushehr Heart Center
    Name of recruitment center - Persian: مرکز قلب بوشهر
    Full name of responsible person - English: Ali Movahed
    Full name of responsible person - Persian: علی موحد
    Street address - English: Moallem ST
    Street address - Persian: خیابان معلم
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 7514633341
    Phone: +98 917 371 1063
    Fax:
    Email: amovahed58@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Farhadi
    Full name of responsible person - Persian: اکرم فرهادی
    Street address - English: Bushehr University of Medical Sciences, Depatment of Resaerch, Salmon Farsi Street, Bahmani, Bushehr, Iran
    Street address - Persian: بوشهر، پردیس، دانشگاه علوم پزشکی، معاونت پژوهشی، خیابان سلمان فارسی، بوشهر، ایران
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 987518759577
    Phone: +98 77 4533 0178
    Fax:
    Email: Researh@BPUMS.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Farhadi
    Full name of responsible person - Persian: اکرم فرهادی
    Street address - English: Salmon Farsi Street, Department of Research, Bahmani, Bushehr University of Medical Sciences.
    Street address - Persian: بوشهر، پردیس، دانشگاه علوم پزشکی، معاونت پژوهشی، خیابان سلمان فارسی، بوشهر، ایران
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 987518759577
    Phone: +98 77 4533 0178
    Fax:
    Email: Researh@BPUMS.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluation of effects of melatonin on heart function and inflammatory and oxidant biomarkers in patients after CABGS.
Design
Clinical trial with a control group, with parallel groups, double-blind, phase 3 on 60 patients. R software version 3.6.3 was used for randomization
Settings and conduct
Patients undergoing CABG surgery at Bushehr Heart Center after discharge from the hospital will complete the consent form and questionnaire. Then 10cc blood sample will be collected from them after consuming melatonin and a placebo for a period of 60 days period of intervention. The project manager, the only person who knows about the codes and the order of assigning people to groups, is not involved in any of the stages of evaluating and measuring the results. On the other hand, the shape, size, and type of packaging of drugs and placebo are completely the same, so the patient and the outcome assessor will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Intention of the patients to participate in the trial, Having no addiction to any drugs or alcohol. Not having mental or psychological disorders. Absence of chronic diseases such as kidney, liver, digestive, and bone diseases. Exclusion criteria: Occurrence of any problems related to surgery, such as heart attack, cardiac arrhythmia, bleeding at the surgical site, myocardial damage, etc.,
Intervention groups
The case group will be given melatonin (5 mg and 10 mg capsules, once a night for 60 days). The control group will be without melatonin
Main outcome variables
Heart Function, including: Ejection Fraction, Atrial fibrillation(AF), ECG, blood pressure( diastolic and Systolic).CK-MB enzyme, LDH enzyme, troponin T, total antioxidant capacity (TAC), malondialdehyde (MDA), TNF-a, hs - CRP, nitric oxide synthase (NO)

General information

Reason for update
Title updated to be more appropriate Randomization method has been modified
Acronym
IRCT registration information
IRCT registration number: IRCT20111119008129N14
Registration date: 2023-08-01, 1402/05/10
Registration timing: prospective

Last update: 2025-02-18, 1403/11/30
Update count: 1
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Ali Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 4044
Email address
a.movahed@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-02-12, 1402/11/23
Actual recruitment start date
2023-08-23, 1402/06/01
Actual recruitment end date
2024-02-12, 1402/11/23
Trial completion date
2024-06-19, 1403/03/30
Scientific title
Melatonin administered postoperatively lowers oxidative stress and inflammation and significantly recovers heart function in patients undergoing CABG Surgery
Public title
Effects of melatonin on patients after coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Intention of the patients to participate in the trial Patients on coronary artery bypass graft surgery Having no addiction to any drugs or alcohol Not having mental or psychological disorders Participants with the age between 30 to 70 years Absence of chronic diseases such as kidney, liver, digestive, bone diseases
Exclusion criteria:
The patient's refusal to continue cooperation after a period of taking the intervention The presence of special conditions after the operation, for example, the patient being unconscious and not being able to take the intervention The occurrence of any problems related to surgery, such as heart attack, cardiac arrhythmia, bleeding at the surgical site, myocardial damage, etc., which causes the patient's condition to become unstable.
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
The samples will be collected before and after the trial
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be permutated block randomization, where A and B represent the two intervention groups and C represents the control group. This method is performed by considering blocks of size 3 patients, so that the total number of 6 permutations is as follows: (A, B, C), (A, C, B), (B, A, C), (B, C, A), (C, A, B), (C, B, A). then, a number of 20 blocks will be randomly selected with replacement from these 6 block types. Finally, the desired list of 20 blocks of 3 (3 × 20 = 60 total number of samples) is generated, and the order of assignment to each of the samples participating in the study is determined. These steps are performed using computerized sequence-numbered codes that are given to the subjects in opaque envelopes at their first visit. Both the clinical team and participants are blinded from the time of randomization until the analysis is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, all melatonin and placebo capsules are prepared in the same shape and size and in packs of 60 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Moallem Street, Bushehr Medical University
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.BPUMS.REC.1402.060

Health conditions studied

1

Description of health condition studied
Diseases of the circulatory system
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The heart function
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By echocardiography

2

Description
Diastolic blood pressure
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By sphygmomanometer, Mercury Type (Company: Microlife)

3

Description
Systolic blood pressure
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By sphygmomanometer, Mercury Type (Company: Microlife)

4

Description
CK-MB (creatine kinase MB)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By reliable kits (By using spectrophotometry)

5

Description
LDH (lactate dehydrogenase)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By reliable kits (By using spectrophotometry)

6

Description
TNF-α (tumor necrosis factor-α)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By ELISA technique

7

Description
hs-CRP (High-sensitivity C-reactive Protein)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By reliable kits (By using spectrophotometry)

8

Description
NO (Nitric oxide)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By ELISA technique

9

Description
Total Antioxidant Capacity (TAC)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By ELISA technique

10

Description
Malondialdehyde
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By reliable kits (By using spectrophotometry)

11

Description
Troponin T
Timepoint
Around 24 hours, before the start of melatonin consumption, and 12 to 24 hours after the period of melatonin consumption (60 days).
Method of measurement
By ELISA technique

Secondary outcomes

1

Description
Alanine aminotransferase (ALT)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption
Method of measurement
By biochemistry auto analyzer- spectrophotometer

2

Description
Aspartate aminotransferase (AST)
Timepoint
Around 24 hours, before the start of melatonin consumption, and 24 to 72 hours after the period of 60 days of melatonin consumption
Method of measurement
By biochemistry auto analyzer- spectrophotometer

3

Description
Alkaline phosphatase (ALP)
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days) .
Method of measurement
By biochemistry auto analyzer- spectrophotometer

4

Description
Blood Urea Nitrogen
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

5

Description
Creatinine (Cr)
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

6

Description
Low density lipids (LDL)
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

7

Description
High density lipid (HDL)
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

8

Description
Cholesterol
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

9

Description
Triglyceride (TG)
Timepoint
Around 24 hours before the start of melatonin consumption, and 24 to 72 hours after the period of melatonin consumption(60 days).
Method of measurement
By biochemistry auto analyzer- spectrophotometer

Intervention groups

1

Description
Control group: The placebo group (250 mg neutral micro cellulose capsules) will be given half an hour before sleep, and all the tests including heart function, and blood sampling, will be exactly like the melatonin intervention group. It will be done before and after the study.
Category
Placebo

2

Description
Intervention group: Melatonin (5 mg capsule) will be given once a night for half an hour before going to sleep, for 60 days.
Category
Prevention

3

Description
Intervention group: This group will be given melatonin (10 mg capsules) once a night for half an hour before going to sleep for 60 days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Heart Center
Full name of responsible person
Ali Movahed
Street address
Moallem ST
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 917 371 1063
Email
amovahed58@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Akram Farhadi
Street address
Salmon Farsi Street, Department of Research, Bahmani, Bushehr University of Medical Sciences.
City
Bushehr
Province
Boushehr
Postal code
987518759577
Phone
+98 77 4533 0178
Email
Researh@BPUMS.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry Laboratory,School of Medicene,Moallem ST
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 4044
Email
a.movahed@bpums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry Laboratory, School of Medicine, BMoallem ST
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 4044
Email
a.movahed@bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry Laboratory,SCHool of Medicine,Moallem ST
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 4044
Email
a.movahed@bpums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The Deputy of Research is responsible to provide the information and documents to the participants in the Trial
When the data will become available and for how long
After the trial was over and the results were analyzed, for a period of one year, access to the document is possible.
To whom data/document is available
The data and other documents of the study will be given to my colleagues at my University and other researchers and academic members from different universities worldwide.
Under which criteria data/document could be used
If the researcher wants the document to use in the following research. The patients who want to know about the results of the examination
From where data/document is obtainable
The main investigator responsible for the trial is to be referred for the results or any other documents. ِDr Ali Movahed, Biochemistry Laboratory, School of Medicine, Moallem ST, Bushehr.Mobile Number: 09173711063
What processes are involved for a request to access data/document
The applicants should submit a request letter to the principal investigator, or a request from the deputy of research. Then, the request will be assessed by these authorities and the right files and documents will be submitted to the requester for a period of one or two weeks.
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