YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1
NCT ID: NCT07032116
Last Updated: 2025-06-22
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
4472 participants
OBSERVATIONAL
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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COHORT
OTHER
Study Groups
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Exposed group
People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect
No interventions assigned to this group
Non-exposed group
Diabetic kidney disease patients who did not receive exposure factors.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 2 18-80 years old, regardless of gender ;
* 3 eGFR \> 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
* 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
* 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
* 6 blood pressure ≤ 160 / 100mmHg ;
* 7 to sign the informed consent ;
Exclusion Criteria
* 2 patients with a history of recurrent genitourinary tract infection ;
* 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
* 4 currently in pregnancy, lactation, or pregnancy plan women ;
* 5 Patients with type 1 diabetes.
* 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.
18 Years
80 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Tianjin Medical University Chu Hsien-I Memorial Hospital
UNKNOWN
Changchun University of Chinese Medicine
OTHER
EFONG PHARMRCEUTICRL
UNKNOWN
Xinxiang Central Hospital of Henan province
UNKNOWN
Xiamen Hospital of Traditional Chinese Medicine
OTHER
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
OTHER
Beijing Tiantan Hospital
OTHER
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
OTHER
Hubei Zhongshan Hospital Affiliated to Wuhan University
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 of BeijingUniversity of Chinese Medicine
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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2023ZD0509303-1
Identifier Type: -
Identifier Source: org_study_id
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