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Набор скоро начнётся NCT07032116

YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1

— Наблюдательное Diabetic Kidney Disease (DKD)

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diabetic Kidney Disease (DKD). Базовые параметры: 18 лет — 80 лет · 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
Китай
Следующий шаг
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Официальное название

Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 1

Обзор

In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years

Первичные конечные точки

  • The incidence of end-stage renal disease [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
Вторичные конечные точки (5)
  • Incidence of renal composite outcome indicators [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
  • Changes of urinary protein creatinine ratio [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
  • Changes of 24-hour urinary protein level [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
  • Estimate the change value of glomerular filtration rate ( eGFR ) level, slope [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
  • Chinese medicine syndrome scores [Срок оценки: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]

Критерии участия

Критерии включения

  • 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
  • 2 18-80 years old, regardless of gender ;
  • 3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
  • 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
  • 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
  • 6 blood pressure ≤ 160 / 100mmHg ;
  • 7 to sign the informed consent ;

Критерии исключения

  • 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
  • 2 patients with a history of recurrent genitourinary tract infection ;
  • 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
  • 4 currently in pregnancy, lactation, or pregnancy plan women ;
  • 5 Patients with type 1 diabetes.
  • 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 5 центров
  • Dongzhimen Hospital of BeijingUniversity of Chinese Medicine — Пекин
  • Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel — Пекин
  • The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
  • The Affiliated Hospital to ChangChun University of Chinese Medicinecancel — Changchun
  • Tianjin Medical University Chu Hsien-I Memorial Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07032116 · 2023ZD0509303-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗