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

Liu Hongfang

Status: Begins enrollment this month

Conditions: Diabetic Kidney Disease (DKD)

Study type: Observational

Funder types: Other

Identifiers

NCT07032116

2023ZD0509303-1

Details and patient eligibility

About

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

Enrollment: 4,472 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 ;
• 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
• 6 blood pressure ≤ 160 / 100mmHg ;
• 7 to sign the informed consent ;

Exclusion criteria

• 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 ;
• 5 Patients with type 1 diabetes.
• 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.

Trial design

4,472 participants in 2 patient groups

Exposed group

Description:

People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect

Non-exposed group

Description:

Diabetic kidney disease patients who did not receive exposure factors.