YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic … (NCT07034807) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study2
China228 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immu…
What they're measuring
1
Glomerular filtration rate ( eGFR ) decline slope
Timeframe: At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.