RecruitingPhase 4NCT07741292

Niaoduqing Granules in Older Adults With Impaired Kidney Function

A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function

Sponsor

Huashan Hospital

Enrollment

300 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease

Summary

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.

Eligibility

Min Age: 61 Years

Inclusion Criteria4

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 Criteria8

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.

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Interventions

DRUGIntervention Name

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.