Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 228
- Locations
- 5
- Primary Endpoint
- Glomerular filtration rate ( eGFR ) decline slope
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Shenzhuo Decoction
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. )
Intervention: the traditional Chinese medicine prescription ' Shenzhuo Decoction ' (Drug)
Shenzhuo Decoction
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. )
Intervention: basic treatment (Combination Product)
basic treatment
the control group was given basic treatment, a total of 1 year of drug intervention（including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc.）
Intervention: basic treatment (Combination Product)
Outcomes
Primary Outcomes
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
- The incidence of renal composite outcome(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 )(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(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(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(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.)
Investigators
Liu Hongfang
Chief Physician
Dongzhimen Hospital, Beijing