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

NCT07032116 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0509303-1
• Study Type: observational
• Target: 4,472
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Diabetic Kidney Disease (DKD)

Outcome Measures

Primary Outcomes (1)

• The incidence of end-stage renal disease

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

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

Secondary Outcomes (5)

• Incidence of renal composite outcome indicators

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

• Changes of urinary protein creatinine ratio

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

• Changes of 24-hour urinary protein level

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

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

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

• Chinese medicine syndrome scores

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

Other Outcomes (37)

• Body temperature

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

• blood pressure

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

• respiration

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

Study Arms (2)

Exposed group

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

Diabetic kidney disease patients who did not receive exposure factors.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
• years old, regardless of gender ;
• eGFR \> 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
• In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
• glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
• blood pressure ≤ 160 / 100mmHg ;
• to sign the informed consent ;

You may not qualify if:

• combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
• patients with a history of recurrent genitourinary tract infection ;
• combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
• currently in pregnancy, lactation, or pregnancy plan women ;
• Patients with type 1 diabetes.
• Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.

Sponsors & Collaborators

• Liu Hongfang: lead
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Tianjin Medical University Chu Hsien-I Memorial Hospital: 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

Study Sites (5)

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Beijing, Beijing Municipality, China

Location

Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Affiliated Hospital to ChangChun University of Chinese Medicinecancel

Changchun, Jilin, China

Location

Tianjin Medical University Chu Hsien-I Memorial Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• HongFang Liu

  Dongzhimen Hospital

  STUDY DIRECTOR

Central Study Contacts

Qingqing Liu

CONTACT

+8615811362511; 125982343@qq.com

Fengyi Cai

CONTACT

+8618810623691; cfy201802@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)