YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study2
NCT ID: NCT07034807
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
228 participants
INTERVENTIONAL
2025-08-01
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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. )
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.
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.）
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel
UNKNOWN
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Tianjin Medical University Chu Hsien-I Memorial Hospital
UNKNOWN
The Affiliated Hospital to ChangChun University of Chinese Medicinecancel
UNKNOWN
EFONG PHARMRCEUTICRL
UNKNOWN
Liu Hongfang
OTHER
Responsible Party
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Liu Hongfang
Chief Physician
Principal Investigators
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HongFang Liu
Role: STUDY_DIRECTOR
Dongzhimen Hospital
Locations
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Dongzhimen Hospital
Beijing, Beijing Municipality, China
Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Hospital to ChangChun University of Chinese Medicinecancel
Changchun, Jilin, China
Tianjin Medical University Chu Hsien-I Memorial Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023ZD0509303-2
Identifier Type: -
Identifier Source: org_study_id
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