Niaoduqing Granules for Older Adults with Kidney Function Decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a real-world, prospective cohort in which about 300 participants over 60 with CKD stages 3–5 (not on dialysis) will receive Niaoduqing Granules 5 g three times daily for 12 months in addition to their usual care. Researchers will monitor kidney function, nutrition, frailty, cardiovascular events, and survival, plus collect samples to study gut microbes and metabolites to understand potential mechanisms. The goal is to see if the granules help slow kidney decline and improve overall health outcomes. The study will take place at Huashan Hospital, Fudan University, with follow-up assessments throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis.
2. Age older than 60 years.
3. The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations.
4. The underlying cause of chronic kidney disease is clinically stable.

Exclusion Criteria:

1. Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease.
2. Active infection, defined as C-reactive protein greater than 10 mg/L, or current use of nephrotoxic medications.
3. Limb paralysis or major limb impairment.
4. 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.
5. Severe gastrointestinal disease affecting nutrient absorption.
6. Current participation in, or participation within the previous month in, another study related to diet or medication.
7. Known allergy to Niaoduqing Granules.
8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jing Chen, Professor and Chief Physician
• Email: chenjing1998@fudan.edu.cn
• Phone: +86 021-52889000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.