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Идёт набор NCT07307677

Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin

Без фазы С лечением PCOS(Insulin Resistant)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Metformin 500mg, Melatonin 3mg.
Кому может быть актуально
Состояния в реестре: PCOS(Insulin Resistant). Базовые параметры: 18 лет — 35 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Bangladesh
Следующий шаг
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Официальное название

Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone

Обзор

Women with polycystic ovary syndrome with HOMA-IR \>2.6 fulfilling inclusion and exclusion criteria will be randomly allocated into two groups:experimental group: A (Melatonin 3mg and Metformin 500mg) and control group: B (Metformin 500mg). Each group will be contained 30 selected patients. Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.

Подробное описание

After obtaining approval of the Institutional Review Board (IRB), this randomized controlled trial will be conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU). Already diagnosed patients of polycystic ovary syndrome with subfertility with HOMA-IR \>2.6 attending in the OPD of Reproductive Endocrinology and Infertility department at BSMMU will be the study population. Women with PCOS fulfilling inclusion and exclusion criteria will be explained in details regarding the objectives, rationality, procedure and potential benefits of the study. The patients will be counselled regarding the drugs and side effects and Informed written consent will be obtained before enrollment.Random allocation will be done using serially numbered closed opaque envelopes. Eligible women will be randomly allocated into two groups:experimental group: A and control group: B. Each group will be contained 30 selected patients.

Group A:Tab. Melatonin (3mg) 3 tablet once daily at night for 12 weeks with Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.

Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.

Data will be collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessments including demographic and clinical information and the result of baseline investigations will be undertaken.

Follow up: Participants will come after one month to assess compliance with the regimen and monitor for any potential side effects. A third visit will be scheduled at the end of the third month for a comprehensive assessment. Any adverse events experienced by participants will be carefully noted and documented throughout the study duration. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.

Вмешательства

  • Препарат Metformin 500mg
    Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
  • Комбинированный продукт Melatonin 3mg
    Melatonin (3mg) 3 tablet single dose at night for 12 weeks and Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks

Первичные конечные точки

  • Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Срок оценки: Baseline to 12 weeks]
Вторичные конечные точки (2)
  • Change in Body Mass Index (BMI) [Срок оценки: Baseline to 12 weeks]
  • Change in Waist Circumference [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

  • Diagnosed case of PCOS according to Rotterdam criteria
  • Women of age 18-35 years
  • Insulin resistance (HOMA-IR >2.6)

Критерии исключения

  • BMI: ≤ 18.5 and ≥ 30 kg/m2
  • Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia)
  • Known case of any medical disease (Renal, hepatic or cardiac disease)
  • Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months.
  • Hypersensitivity to melatonin.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Bangladesh · 1 центр
  • Bangladesh Medical University — Dhaka

Публикации

  • Chen W, Zhang H, Guo B, Tao Y, Zhang J, Wang J, Chen G, Cheng M, Hong Q, Cao Y, Xie F. Melatonin refines ovarian mitochondrial dysfunction in PCOS by regulating the circadian rhythm gene Clock. Cell Mol Life Sci. 2025 Mar 6;82(1):104. doi: 10.1007/s00018-025-05609-9. PMID 40047877
  • Ziaei S, Hasani M, Malekahmadi M, Daneshzad E, Kadkhodazadeh K, Heshmati J. Effect of melatonin supplementation on cardiometabolic risk factors, oxidative stress and hormonal profile in PCOS patients: a systematic review and meta-analysis of randomized clinical trials. J Ovarian Res. 2024 Jul 4;17(1):138. doi: 10.1186/s13048-024-01450-z. PMID 38965577

Идентификаторы

NCT: NCT07307677 · 5498

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗