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

NCT07034807 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0509303-2
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetic Kidney Disease (DKD)

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate ( eGFR ) decline slope

  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 (5)

• The incidence of renal composite outcome

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

• Urinary albumin creatinine ratio (UACR )

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

• Changes in 24-hour urinary protein levels

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

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

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

• Changes of Traditional Chinese Medicine syndrome integrals

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

Other Outcomes (38)

• Body temperature

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

• blood pressure

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

• respiration

  Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.

Study Arms (2)

Shenzhuo Decoction

EXPERIMENTAL

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. )

Drug: the traditional Chinese medicine prescription ' Shenzhuo Decoction '; Combination Product: basic treatment

basic treatment

ACTIVE COMPARATOR

the control group was given basic treatment, a total of 1 year of drug intervention（including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc.）

Combination Product: basic treatment

Interventions

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.

Also known as: Chinese medicine

Shenzhuo Decoction

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.

Also known as: control group

Shenzhuo Decoction; basic treatment

Eligibility Criteria

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

You may qualify if:

• In line with the diagnostic criteria of Western medicine type 2 DKD ;
• years old, regardless of gender ;
• ml / min / 1.73m2 ≤ eGFR \< 60ml / min / 1.73m2 ( eGFR was calculated according to CKD-EPI formula ) ;
• In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
• hbA1c between 7-10 % ;
• uACR ≥ 300mg / g
• blood pressure ≤ 150 / 90mmHg ;
• signed the informed consent ;

You may not qualify if:

• Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ;
• combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumors ;
• 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 ) ;
• patients who were allergic or contraindicated to the planned use of drugs ;
• There are serious acute or chronic diseases that the major researchers believe may pose an excessive risk to the subjects, including : patients with cardiovascular, cerebrovascular, lung, blood, digestive tract, liver, kidney, neuropsychiatric or infectious diseases ;
• Patients with a history of immunodeficiency, including patients with other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation or planned organ transplantation ;
• Women with positive pregnancy screening test or lactating or planning to get pregnant in the next 24 months. Female or male patients who were reluctant to use contraception throughout the study period ;
• patients with a history of malignant tumors within 5 years ;
• patients with type 1 diabetes ;

Sponsors & Collaborators

• Liu Hongfang: lead
• Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Tianjin Medical University Chu Hsien-I Memorial Hospital: collaborator
• The Affiliated Hospital to ChangChun University of Chinese Medicinecancel: collaborator
• EFONG PHARMRCEUTICRL: collaborator

Study Sites (5)

Dongzhimen Hospital

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

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: the practical randomized controlled trial designed by Zelen

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)