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NCT Number: NCT07034807

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

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.

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Key information

Conditions

Diabetic Kidney Disease (DKD) Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongzhimen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ;
  • 5 hbA1c between 7-10 % ;
  • 6 uACR ≥ 300mg / g
  • 7 blood pressure ≤ 150 / 90mmHg ;
  • 8 signed the informed consent ;

Exclusion criteria

  • 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 ) ;
  • 5 patients who were allergic or contraindicated to the planned use of drugs ;
  • 6 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 ;
  • 7 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 ;
  • 8 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 ;
  • 9 patients with a history of malignant tumors within 5 years ;
  • 10 patients with type 1 diabetes ;
  • 11 patients with maintenance dialysis > 2 weeks and / or expected maintenance dialysis > 8 weeks before treatment and patients who were judged by any researcher not suitable for inclusion in the trial.

Treatment and study plan

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.

Other names: Chinese medicine

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.

Other names: control group

Primary outcomes

  1. 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

  1. The incidence of renal composite outcome

    Time frame: 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.

    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

  2. Urinary albumin creatinine ratio (UACR )

    Time frame: 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.

  3. Changes in 24-hour urinary protein levels

    Time frame: 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.

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

    Time frame: 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.

  5. Changes of Traditional Chinese Medicine syndrome integrals

    Time frame: 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.

    The symptoms of the patients were scored with the Traditional Chinese Medicine syndrome scale to better judge the changes of the symptoms of the patients.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health.

Other outcomes

  1. Body temperature

    Time frame: 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.

  2. blood pressure

    Time frame: 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.

    Both systolic and diastolic blood pressures should be measured

  3. respiration

    Time frame: 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.

  4. heart rate

    Time frame: 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.

  5. Number of participants with abnormal white blood cell count ( WBC )

    Time frame: 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.

    Number of participants with abnormal white blood cell count ( WBC )

  6. Number of participants with abnormal red blood cell count ( RBC )

    Time frame: 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.

    Number of participants with abnormal red blood cell count ( RBC )

  7. Number of participants with abnormal electrocardiogram

    Time frame: 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.

    Number of participants with abnormal electrocardiogram

  8. Number of participants with abnormal hemoglobin ( HGB )

    Time frame: 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.

    Number of participants with abnormal hemoglobin ( HGB )

  9. Number of participants with abnormal lymphocyte percentage ( LY % )

    Time frame: 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.

    Number of participants with abnormal lymphocyte percentage ( LY % )

  10. blood lipid

    Time frame: 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.

  11. glycosylated hemoglobin

    Time frame: 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.

  12. fasting blood glucose

    Time frame: 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.

  13. incidence of adverse events

    Time frame: 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.

  14. Number of participants with abnormal Percentage of neutrophils( NE % )

    Time frame: 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.

    Number of participants with abnormal Percentage of neutrophils( NE % )

  15. Number of participants with abnormal Platelet count ( PLT )

    Time frame: 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.

    Number of participants with abnormal Platelet count ( PLT )

  16. Number of participants with abnormal Urine PH value

    Time frame: 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.

    Number of participants with abnormal Urine PH value

  17. Number of participants with abnormal Urinary protein

    Time frame: 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.

    Number of participants with abnormal Urinary protein

  18. Number of participants with abnormal Urine occult blood

    Time frame: 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.

    Number of participants with abnormal Urine occult blood

  19. Number of participants with abnormal Urinary glucose

    Time frame: 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.

    Number of participants with abnormal Urinary glucose

  20. Number of participants with abnormal Urine ketone

    Time frame: 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.

    Number of participants with abnormal Urine ketone

  21. Number of participants with abnormal Urine white blood cells (high magnification field of view)

    Time frame: 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.

    Number of participants with abnormal Urine white blood cells (high magnification field of view)

  22. Number of participants with abnormal Urine red blood cells (high magnification field of view)

    Time frame: 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.

    Number of participants with abnormal Urine red blood cells (high magnification field of view)

  23. Number of participants with abnormal Serum alanine aminotransferase

    Time frame: 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.

    Number of participants with abnormal Serum alanine aminotransferase

  24. Number of participants with abnormal Serum aspartate aminotransferase

    Time frame: 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.

    Number of participants with abnormal Serum aspartate aminotransferase

  25. Number of participants with abnormal Serum alkaline phosphatase

    Time frame: 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.

    Number of participants with abnormal Serum alkaline phosphatase

  26. Number of participants with abnormal Serum gamma-glutamyl transferase

    Time frame: 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.

    Number of participants with abnormal Serum gamma-glutamyl transferase

  27. Number of participants with abnormal Serum albumin (ALB)

    Time frame: 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.

    Number of participants with abnormal Serum albumin (ALB)

  28. Number of participants with abnormal Serum total bilirubin（TBIL）

    Time frame: 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.

    Number of participants with abnormal Serum total bilirubin（TBIL）

  29. Number of participants with abnormal Serum direct bilirubin（DBIL）

    Time frame: 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.

    Number of participants with abnormal Serum direct bilirubin（DBIL）

  30. Number of participants with abnormal Serum indirect bilirubin （IBIL）

    Time frame: 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.

    Number of participants with abnormal Serum indirect bilirubin （IBIL）

  31. Serum urea

    Time frame: 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.

    Serum urea

  32. Serum urate

    Time frame: 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.

    Serum urate

  33. Serum cystatin C

    Time frame: 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.

    Serum cystatin C

  34. Serum creatinine

    Time frame: 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.

    Serum creatinine

  35. Plasma triglyceride

    Time frame: 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.

    Plasma triglyceride

  36. Plasma high-density lipoprotein

    Time frame: 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.

    Plasma high-density lipoprotein

  37. Plasma low-density lipoprotein

    Time frame: 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.

    Plasma low-density lipoprotein

  38. Plasma total cholesterol

    Time frame: 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.

    Plasma total cholesterol

Study contacts

Contact information is provided by the study sponsor or research team.

Fengyi Cai

CONTACT

[email protected]

+8618810623691

Qingqing Liu

CONTACT

[email protected]

+8615811362511

Sponsors and collaborators

Lead sponsor

Liu Hongfang

Other

Collaborators

  • Affiliated Hospital of Changchun University of Chinese Medicine
  • EFONG PHARMRCEUTICRL
  • First Affiliated Hospital, Sun Yat-Sen University
  • Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel
  • Tianjin Medical University

Registry information

Official study title

Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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