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YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1

ConditionDiabetic Kidney Disease (DKD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorLiu Hongfang

About this trial

In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;

2 18-80 years old, regardless of gender ;

3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).

4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;

Disqualifiers

1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;

2 patients with a history of recurrent genitourinary tract infection ;

3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;

4 currently in pregnancy, lactation, or pregnancy plan women ;

Trial population

Diabetic kidney disease patients, in line with the inclusion criteria, do not meet the exclusion criteria

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

4,472 Participants
are grouped into 2 trial groups
Group A: Exposed group
Group B: Non-exposed group

Trial outcomes

Primary outcomes

1

The incidence of end-stage renal disease

dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 )

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years

Secondary outcomes

1

Incidence of renal composite outcome indicators

End-stage renal disease \[ dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 ) \], eGFR decreased by more than 50 %, renal causes of death were defined.

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
2

Changes of urinary protein creatinine ratio

Changes of urinary protein creatinine ratio

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
3

Changes of 24-hour urinary protein level

Changes of 24-hour urinary protein level

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
4

Estimate the change value of glomerular filtration rate ( eGFR ) level, slope

Estimate the change value of glomerular filtration rate ( eGFR ) level, slope

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years

Other outcomes

1

Body temperature

Body temperature

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
2

blood pressure

Both systolic and diastolic blood pressures should be measured.

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
3

respiration

respiration

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years.
4

heart rate

heart rate

Time frame
Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Hongfang

Lead sponsor

Dongzhimen Hospital, Beijing

Sponsor institution

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Tianjin Medical University

Collaborator

Changchun University of Chinese Medicine

Collaborator

EFONG PHARMRCEUTICRL

Collaborator

Xinxiang Central Hospital of Henan province

Collaborator

Xiamen Hospital of Traditional Chinese Medicine

Collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Collaborator

Beijing Tiantan Hospital

Collaborator

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Hubei Zhongshan Hospital Affiliated to Wuhan University

Collaborator

Source ClinicalTrials.gov

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