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NCT07034807Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
228 (estimated)
First submitted
8 Apr 2025
Start date
1 Aug 2025
Primary completion date
31 Jul 2028
Lead sponsor
Liu Hongfang
NCT number
NCT07034807

What you commit to

  • Study type: Interventional
  • Planned participants: 228
  • From 1 Aug 2025 to the primary completion date, 31 Jul 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1 Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ;
  • 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 ) ;
  • 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.

Other illness

  • 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 ;
  • 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 ;
  • 9 patients with a history of malignant tumors within 5 years ;
  • 10 patients with type 1 diabetes ;

Other

  • 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 ;

Who the study is looking for

  • 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 ;

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guang'anmen Hospital,China Academy of Chinese Medical Sciencescancel
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Dongzhimen Hospital
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BeijingChinaUnknown status
The Affiliated Hospital to ChangChun University of Chinese Medicinecancel
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
the First Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Tianjin Medical University Chu Hsien-I Memorial Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.