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Evaluation and Optimization Scheme of Individualized Treatment Based on Syndrome-Guided Disease Management for Renal Edema (Yang Deficiency Syndrome of Edema Disease) Using a Subgroup-Based Dynamic-Static Parallel Group Design

Construction and Demonstration Research of a Dynamic-Static TCM Clinical Evaluation Methodology Based on Syndrome Element Identification and State Measurability Principle: A Demonstrative Study on Priority Disease Categories

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002112
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TCM disease: Edema disease Western medicine diseases: Diabetic kidney disease, Chronic kidney disease, Cardiorenal syndrome

Interventions

Western Medicine Group:Conventional Western Medicine Therapy
Traditional Chinese MedicineGroup:Conventional Western Medicine Therapy &TCM Syndrome Differentiation and Treatment

Sponsors

The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)General inclusion criteria 1) Meet the diagnostic criteria for edema disease; 2) The Chinese medicine diagnosis is Yang deficiency; 3) The patient has good compliance with the medical advice of Chinese and Western medicine treatment; 4) Can understand and cooperate with the questionnaire and sign the informed consent form; 5) Because of the aging tendency of this disease, the age range of the subjects was set at 18-80 years old. (2)Inclusion criteria by disease category 1)DKD: Western medicine diagnosis was consistent with DKD; 2)CKD: Western medicine diagnosis was consistent with CKD stage 1-4, except DKD and CRS; 3)CRS: the western medical diagnosis was consistent with CRS 1-5, and those with simple CKD and DKD were excluded.

Exclusion criteria

Exclusion criteria: 1) Other causes of edema; 2) Combination of other serious diseases, including patients with renal insufficiency hemodialysis (CDK5 stage); 3) Those who are allergic to the drugs used in this study; 4)Pregnant or lactating women; 5) People with mental illness or mental retardation; 6) Those who have participated within the last 1 monthor or have been participating in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine Symptom Graded Quantification Score Sheet ;urine albumin to creatinine ratio;N-terminal pro-B-type natriuretic peptide;Renal Function Tests;TCMHealth Status Rating Scale;Chronic Kidney Disease Quality of Life Scale;

Secondary

MeasureTime frame
fasting blood glucose;blood lipid;

Countries

China

Contacts

Public ContactLiu Lanying

The Third Affiliated Hospital of Beijing University of Chinese Medicine

killnotes@163.com13693009728

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026