Niaoduqing Granules in Older Adults With Impaired Kidney Function
2026年7月28日 更新者：Chen Jing、Huashan Hospital
A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function
This prospective real-world study will evaluate the clinical benefits of Niaoduqing Granules in older adults with impaired kidney function. Approximately 300 participants aged over 60 years with stage 3 to 5 chronic kidney disease who are not receiving dialysis will be enrolled at Huashan Hospital, Fudan University. The study will examine whether treatment with Niaoduqing Granules is associated with slower kidney function decline and improvements in nutrition, frailty, and other health outcomes.
Participants will receive 5 g of Niaoduqing Granules three times daily after meals for 12 months, while continuing their usual treatment for chronic diseases as directed by their physicians. Kidney function, laboratory results, nutritional status, frailty, cardiovascular and cerebrovascular events, and survival will be assessed during follow-up. Blood, urine, and stool samples will also be collected to study changes in gut microorganisms and blood metabolites that may help explain how Niaoduqing Granules affect health. Participants will be followed for up to 60 months.
研究概览
研究类型
介入性
注册 (估计的)
300
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jing Chen, Professor and Chief Physician
- 电话号码：+86 021-52889000
- 邮箱：chenjing1998@fudan.edu.cn
学习地点
-
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、20040
- 招聘中
- Huashan Hospital, Fudan University
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接触：
- Jing Chen
- 电话号码：+86 021-52889000
- 邮箱：chenjing1998@fudan.edu.cn
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis.
- Age older than 60 years.
- The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations.
- The underlying cause of chronic kidney disease is clinically stable.
Exclusion Criteria:
- Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease.
- Active infection, defined as C-reactive protein greater than 10 mg/L, or current use of nephrotoxic medications.
- Limb paralysis or major limb impairment.
- Use of immunosuppressive therapy, including cyclosporine or tacrolimus, within the 3 months before cohort enrollment, or use of corticosteroids at a dose equivalent to more than 10 mg/day of prednisone.
- Severe gastrointestinal disease affecting nutrient absorption.
- Current participation in, or participation within the previous month in, another study related to diet or medication.
- Known allergy to Niaoduqing Granules.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Niaoduqing Granules
Participants will receive Niaoduqing Granules 5 g orally three times daily at 6:00, 12:00, and 18:00 after meals for 12 months.
Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions will be continued or adjusted according to specialist recommendations.
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Niaoduqing Granules will be administered orally at a dose of 5 g three times daily at 6:00, 12:00, and 18:00 after meals with warm water for 12 months.
Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions may be continued or adjusted according to specialist recommendations.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Occurrence of Rapid Kidney Function Decline
大体时间：Every 12 months from baseline through Month 60
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Rapid kidney function decline is defined as an annual decrease in estimated glomerular filtration rate (eGFR) of more than 5%.
The occurrence of rapid kidney function decline will be determined using serial kidney function measurements obtained during follow-up.
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Every 12 months from baseline through Month 60
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Chronic Kidney Disease Complications
大体时间：Every 12 months from baseline through Month 60
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The number and percentage of participants who develop chronic kidney disease complications, including renal anemia and/or chronic kidney disease-mineral and bone disorder (CKD-MBD), during follow-up.
Outcomes will be assessed using clinical evaluations and relevant laboratory test results collected according to the study protocol.
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Every 12 months from baseline through Month 60
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Occurrence of Malnutrition
大体时间：At baseline and every 12 months through Month 60
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Malnutrition will be assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria.
A participant will be classified as having malnutrition when at least one phenotypic criterion, including involuntary weight loss, low body mass index, or reduced muscle mass, and at least one etiologic criterion, including reduced food intake or absorption or disease burden/inflammation, are present.
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At baseline and every 12 months through Month 60
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Occurrence of Frailty
大体时间：At baseline and every 12 months through Month 60
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Frailty status will be assessed using a rapid geriatric frailty screening scale.
The number and percentage of participants identified as having frailty according to the screening assessment will be recorded.
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At baseline and every 12 months through Month 60
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Occurrence of Cardiovascular and Cerebrovascular Events
大体时间：From baseline through Month 60
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The number and percentage of participants who experience one or more cardiovascular or cerebrovascular events during follow-up.
Events include acute myocardial infarction, unstable angina, coronary heart disease, acute heart failure or worsening chronic heart failure, new-onset arrhythmia, acute cerebral infarction, transient ischemic attack, intracerebral hemorrhage, peripheral vascular disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, valvular heart disease, or aortic disease.
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From baseline through Month 60
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All-Cause Mortality
大体时间：From baseline through Month 60
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The number and percentage of participants who die from any cause during the study follow-up period.
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From baseline through Month 60
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月1日
初级完成 (估计的)
2030年11月30日
研究完成 (估计的)
2030年11月30日
研究注册日期
首次提交
2026年7月28日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KY2024-1366
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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