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

Phase 1

• Conditions: Chronic kidney disease

• Registration Number: ITMCTR2200006459
• Lead Sponsor: The First Affiliated Hospital of Wenzhou Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 < 60ml/min/1.73m2=3 months,with or without evidence of kidney damage.If one of the above conditions is met,the diagnosis can be made. ?
Clinical stages: CKD stage I: GFR > 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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum creatinine;

Secondary Outcome Measures

Name	Time	Method
scores of TCM syndrome;Shear-wave elastography;the serum level of FGF21;