Silymarin's Advantage on Graft Effectiveness
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: Silymarine supplementation, Placebo Supplementation.
- Кому может быть актуально
- Состояния в реестре: Posttransplant Diabetes Mellitus, Acute Graft Rejection, Biopsy Proven Acute Rejection, Antibody Mediated Rejection of Kidney Transplant. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Словакия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Silymarin Supplementation on Graft Function and Early Post-transplant Complications
Обзор
The study examines the impact of silymarin supplementation during the early post-transplant period, administering 900 g daily for 30 days under standard treatment. Subsequently, the investigators investigate its impact on graft function, as measured by eGFR (CKD-EPI equation), UACR or UPCR, the development of dnDSA, rejection changes, and histological changes in the 3-month biopsy protocol. At the same time, investigators will investigate the effect of silymarin on metabolic complications-PTDM, DLP, disorders of calcium-phosphate metabolism, and arterial hypertension in the post-transplant period-in comparison with the placebo group. At the same time, investigators will investigate the safety and tolerance of silymarin.
Вмешательства
- Препарат Silymarine supplementation
900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment. - Другое Placebo Supplementation
Placebo supplementation during the early post-transplant period (30 days) under standard treatment
Первичные конечные точки
- eGFR improvement [Срок оценки: 3 months]
- Inicidence of biopsy proven acute rejection [Срок оценки: 6 months]
Вторичные конечные точки (3)
- Incidence of PTDM [Срок оценки: 6 months]
- Incidence of dyslipidemia [Срок оценки: 6 months]
- Improved graft function in participatns with delayed graft function [Срок оценки: 6 months]
Критерии участия
Критерии включения
- First or second kidney transplant recipient
- Deceased or living donor kidney transplant
- Patients receiving standard immunosuppression regimen:
- Tacrolimus or cyclosporine + Mycophenolate mofetil + Corticosteroids
- Body Mass Index (BMI) 18-35 kg/m²
- Willingness to provide informed consent
- Ability to understand and comply with study procedures
- Stable medical condition without significant comorbidities
Критерии исключения
- Multi-organ transplant recipients
- Recipients of ABO-incompatible or highly sensitized transplants
- Active infectious complications at the time of transplantation: HIV, Active hepatitis B or C, Active cytomegalovirus (CMV) infection
- Patients with known liver disease: Cirrhosis, Active hepatitis, ALT or AST > 2.5 times the upper limit of normal
- Significant cardiovascular disease: Recent myocardial infarction (within 6 months), Unstable angina, Severe heart failure (NYHA Class III or IV)
- Malignancy within the past 5 years (except successfully treated non-melanoma skin cancer)
- Current or recent (within 30 days) participation in another clinical trial
- Pregnancy or planned pregnancy during the study period
- Known allergy or hypersensitivity to silymarin or milk thistle
- Patients taking medications with significant interactions with silymarin:
Anticoagulants, Cytochrome P450 enzyme modulators
- Psychiatric conditions that may interfere with study compliance
- Uncontrolled diabetes mellitus (HbA1c > 8.5%)
- History of non-compliance with medical treatment
- Patients with known genetic disorders affecting drug metabolism
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
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Словакия · 1 центр
- University Hospital Martin — Martin
Публикации
- Goli F, Karimi J, Khodadadi I, Tayebinia H, Kheiripour N, Hashemnia M, Rahimi R. Silymarin Attenuates ELMO-1 and KIM-1 Expression and Oxidative Stress in the Kidney of Rats with Type 2 Diabetes. Indian J Clin Biochem. 2019 Apr;34(2):172-179. doi: 10.1007/s12291-018-0735-0. Epub 2018 Feb 6. PMID 31092990
- Kaur G, Athar M, Alam MS. Dietary supplementation of silymarin protects against chemically induced nephrotoxicity, inflammation and renal tumor promotion response. Invest New Drugs. 2010 Oct;28(5):703-13. doi: 10.1007/s10637-009-9289-6. Epub 2009 Jul 10. PMID 19590824
- Mohammadi H, Hadi A, Arab A, Moradi S, Rouhani MH. Effects of silymarin supplementation on blood lipids: A systematic review and meta-analysis of clinical trials. Phytother Res. 2019 Apr;33(4):871-880. doi: 10.1002/ptr.6287. Epub 2019 Mar 5. PMID 30834633
- Voroneanu L, Nistor I, Dumea R, Apetrii M, Covic A. Silymarin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Diabetes Res. 2016;2016:5147468. doi: 10.1155/2016/5147468. Epub 2016 Jun 1. PMID 27340676
Идентификаторы
NCT: NCT06801886 · TNO_UNM