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Clinical Trials in China / NCT07034807
Starting soon Not applicable

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

NCT07034807 · tracked via the Priya Life Science China tracker
Sponsor
Liu Hongfang
Phase
Not applicable
Started
2025-08-01
Last updated
2025-06-24

Condition(s) studied

Diabetic Kidney Disease (DKD)

Investigational drug(s) / intervention(s)

the traditional Chinese medicine prescription ' Shenzhuo Decoction 'basic treatment

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

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

More Liu Hongfang trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07034807 on ClinicalTrials.gov ↗ ← All trials in China