Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence

Официальное название

Research on New Diagnosis and Treatment Technologies for Major Traditional Chinese Medicine Advantage Diseases - Multi-Omics and Artificial Intelligence-Driven Innovative TCM Diagnosis and Treatment Technologies for Diabetic Nephropathy

Обзор

With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing effective means to improve DKD remission rates, delay disease progression, and enhance patients' quality of life. By selecting the Jiade Yishen Xiaozheng Qufang formula and conducting multicenter, prospective, double-blind RCT studies, its clinical value in improving DKD remission rates can be verified. With the support of scientific research, DKD treatment strategies can be optimized, therapeutic efficacy improved, recurrence rates reduced, and disease progression delayed, thereby enhancing patients' quality of life.

Подробное описание

Cooperative units jointly carry out a prospective randomized placebo-controlled parallel double-blind study, relying on a multi-center clinical research platform, and verify through multi-center, prospective, double-blind RCT studies the clinical value of the Jia Jian Yi Shen Xiao Zheng Qu Feng Formula in improving the remission rate of DKD, in order to optimize the treatment strategy for DKD.

Вмешательства

• Препарат Jiajian Yishen Xiaozheng Qufeng Granules
  Involving unlisted drugs, vaccines, medical devices, and other products;Unlisted product type: Medicine;Unlisted product name: Jia Jian Yi Shen Xiao Zheng Qu Feng Fang Granules;Unlisted Product Preparation Organization: Jiangyin Tianjiang Pharmaceutical Co., Ltd.;Type of preparation institution for unlisted products: Domestic (within China).

Первичные конечные точки

• UACR/UAER/24-hour urinary protein returns to normal or decreases by 50% compared with before. [Срок оценки: Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24]

Критерии участия

Критерии включения

• Meets the clinical diagnostic criteria for diabetic nephropathy;
• Aged 18-75 years, any gender;
• eGFR >45 ml/min/1.73m²;
• 24-hour urine protein <2.0 g/day;
• Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;
• Willing to participate in the study, able to attend regular follow-ups, and provide informed consent;
• Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for ≥1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted.

Критерии исключения

• Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.);
• Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);
• Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);
• Critical organ failure (severe diseases of the heart, liver, or lungs);
• Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);
• Drug allergy or clear contraindications (allergic to the study drug or its components);
• Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements);
• Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk;
• Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07459946 · MR-33-26-016396

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗