Niaoduqing Granules in Older Adults With Impaired Kidney Function
28 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
300
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jing Chen, Professor and Chief Physician
- Telefonnummer: +86 021-52889000
- E-post: chenjing1998@fudan.edu.cn
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 20040
- Rekrytering
- Huashan Hospital, Fudan University
-
Kontakt:
- Jing Chen
- Telefonnummer: +86 021-52889000
- E-post: chenjing1998@fudan.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurrence of Rapid Kidney Function Decline
Tidsram: Every 12 months from baseline through Month 60
|
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.
|
Every 12 months from baseline through Month 60
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Chronic Kidney Disease Complications
Tidsram: Every 12 months from baseline through Month 60
|
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.
|
Every 12 months from baseline through Month 60
|
|
Occurrence of Malnutrition
Tidsram: At baseline and every 12 months through Month 60
|
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.
|
At baseline and every 12 months through Month 60
|
|
Occurrence of Frailty
Tidsram: At baseline and every 12 months through Month 60
|
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.
|
At baseline and every 12 months through Month 60
|
|
Occurrence of Cardiovascular and Cerebrovascular Events
Tidsram: From baseline through Month 60
|
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.
|
From baseline through Month 60
|
|
All-Cause Mortality
Tidsram: From baseline through Month 60
|
The number and percentage of participants who die from any cause during the study follow-up period.
|
From baseline through Month 60
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2025
Primärt slutförande (Beräknad)
30 november 2030
Avslutad studie (Beräknad)
30 november 2030
Studieregistreringsdatum
Först inskickad
28 juli 2026
Först inskickad som uppfyllde QC-kriterierna
28 juli 2026
Första postat (Faktisk)
3 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Näringsstörningar
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Svaghet
- Undernäring
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- KY2024-1366
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .