YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study2

ConditionDiabetic Kidney Disease (DKD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorLiu Hongfang

About this trial

Using the practical randomized controlled trial designed by Zelen, the subjects were randomly divided into the experimental group and the control group. The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ), the control group was given basic treatment, a total of 1 year of drug intervention, followed up for 1 year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1 In line with the diagnostic criteria of Western medicine type 2 DKD ;

2 18-80 years old, regardless of gender ;

3 30ml / min / 1.73m2 ≤ eGFR < 60ml / min / 1.73m2 ( eGFR was calculated according to CKD-EPI formula ) ;

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

Disqualifiers

1 Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ;

2 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumors ;

3 Patients with acute or chronic infection who needed treatment were judged by the researchers not suitable for inclusion in the study ;

4 Patients who participated in any other research drug study and / or received or had received another research drug or intervention treatment ( within one month before signing the informed consent form ) ;

Trial design

Design model

Parallel

Treatments tested in this trial

the traditional Chinese medicine prescription ' Shenzhuo Decoction '
Drug
The traditional Chinese medicine prescription ' Shenzhuo Decoction ' is composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort. It is a traditional Chinese medicine prescription for the treatment of diabetic kidney disease, which was founded by Tong Xiaolin, an academician of the Chinese Academy of Sciences.
basic treatment
Combination product
Basic treatment includes six aspects : nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, and control of other risk factors, which are implemented in accordance with clinical standard treatment specifications.

Treatment groups

228 Participants

are divided into 2 treatment groups

Group A: Shenzhuo DecoctionExperimental treatment 2 interventions

Group B: basic treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

Glomerular filtration rate ( eGFR ) decline slope

Time frame

At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

Secondary outcomes

The incidence of renal composite outcome

Defined as the occurrence of end-stage renal disease \[ dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 ) \], eGFR decreased by more than 50 %, death caused by renal causes

Time frame