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Cooperative Study on Evidence-Based Evaluation and Therapeutic Mechanism of Yishentongluo Formula in the Intervention of DKD (Phase 3)

Cooperative Study on Evidence-Based Evaluation and Therapeutic Mechanism of Yishentongluo Formula in the Intervention of DKD (Phase 3)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000352
Enrollment
Unknown
Registered
2024-09-02
Start date
2022-10-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Diabetic Kidney Disease

Interventions

Experimental group:Oral administration of Yishen Tongluo Formula aqueous solution
Control group:Oral administration of Yishen Tongluo Formula Simulant

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Meets the diagnostic criteria for DKD (Phase 3) 2: Traditional Chinese Medicine syndrome differentiation meets the criteria for liver and kidney yin deficiency combined with blood stasis syndrome 3: Age 18-75 years old 4: Voluntarily accept treatment and sign an informed consent form

Exclusion criteria

Exclusion criteria: 1:   Patients with acute complications of diabetes and urinary tract infection within one month 2:   Patients with severe primary diseases such as liver kidney and hematopoietic system combined 3:   Patients with severe cardiovascular and cerebrovascular diseases 4:   Pregnant or lactating women or those preparing for pregnancy 5:   Individuals with mental illness or cognitive impairment 6:   Individuals with allergic constitution or allergic to the composition of the drug in this preparation 7:   Participants in other clinical trials within one month prior to enrollment

Design outcomes

Primary

MeasureTime frame
Ratio of urinary microalbumin to urinary creatinine;

Secondary

MeasureTime frame
Traditional Chinese Medicine Symptom Score;Tumor necrosis factor a;2-hour Postprandial Blood Glucose;Cystatin C;High-density lipoprotein cholesterol;Interleukin-6;Serum Total Cholesterol;EuroQol five dimensions questionnaire;estimated glomerular filtration rate;Triglyceride;Serum uric acid;Diabetes quality of life measure;Blood urea nitrogen;Interleukin-1;Fasting Blood Glucose;Serum creatinine;Glycosylated hemoglobin;C-reactive protein;Low-density lipoprotein cholesterol;

Countries

China

Contacts

Public ContactJiangyan Xu

Henan University of Chinese Medicine

xujiangyan2008@163.com19900971608

Outcome results

None listed

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