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Study on the therapeutic effect and mechanism of Nephropathy No.1 prescription in the treatment of chronic kidney disease with damp-heat and obstructed kidney collaterals

Treatment of nephrology with integrated Traditional Chinese and western medicine

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006459
Enrollment
Unknown
Registered
2022-08-09
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

1:Control group:basic treatment
2:intervention group:basic treatment +TCM

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: CKD diagnostic criteria[37]: ?kidney damage 3 months or morecan be with or without glomerular filtration rate decreased, can be characterized by any of the below abnormal pathology examination:including abnormal composition of bloodurine or abnormal imaging examination;?Glomerular filtration rate 89ml/min/1.73m2;??CKD stage II: GFR 60-89ml/min/1.73m2;??CKD stage III: GFR 30-59ml/min/1.73m2.??eGFR was estimated by MDRD formula as follows: eGFR (ml/min·1.73m2)=186× (Scr)-1.154×(age)-0.203× (female×0.742).? Diagnostic criteria of TCM Refer to the criteria of damp-heat of renal collaterals and incompletely flowing collaterals in TCM «Clinical Diagnosis and Treatment Guide of Kidney Collateral Diseases of TCM»[16] edited by Lu Ying et al in 2017:soreness and lumbago,tiredness and fatigue,nausea and vomiting, dry mouth and bitter mouth,dull abdominal distension,dry stool,oliguria,red tongue,yello, greasy,thick or dry tongue,and smooth pulse. Inclusion criteria 1.Patients who met the following diagnostic criteria for CKD1-III stage. 2.In accordance with the TCM syndrome differentiation of damp-heat of renal collaterals and incompletely flowing collaterals. 3.Primary chronic kidney disease. 4.Over 18 of age, signed an informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.With serious primary diseases such as heart, brain, lung, liver and hematopoietic system, or with wasting diseases such as malignant tumor and active tuberculosis, or the latter of kidney transplantation, or the recent acute aggravation of renal function, or serious infection, acidosis, electrolyte disorder, etc. have not been controlled. 3.Patients unable to cooperate such as psychopath. 4.Patients enrolled in other clinical medicine trial. 5.Patients with severe anemia and hemoglobin was below 60g/L. 6.Allergic constitution. 7.Patients using hormones or immunosuppressants in the last 3 months. 8.Secondary renal disease. 9.Patients taking chinese herbal medicine in the past week.

Design outcomes

Primary

MeasureTime frame
serum creatinine;

Secondary

MeasureTime frame
scores of TCM syndrome;Shear-wave elastography;the serum level of FGF21;

Countries

China

Contacts

Public ContactCheng Jinguo
wzchengjinguo@126.com13857797188

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026