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

Official 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

Overview

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.

Interventions

• Drug the traditional Chinese medicine prescription ' Shenzhuo Decoction '
  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.
• Combination product basic treatment
  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.

Primary outcome measures

• 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 outcome measures (5)

• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• Dongzhimen Hospital — Beijing
• Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel — Beijing
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
• The Affiliated Hospital to ChangChun University of Chinese Medicinecancel — Changchun
• Tianjin Medical University Chu Hsien-I Memorial Hospital — Tianjin

Identifiers

NCT: NCT07034807 · 2023ZD0509303-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗