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Study to Evaluate the Effect of ''Tangshen Fang'' combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Diabetes Nephropathy: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medicine in the Treatment

Study to Evaluate the Effect of ''Tangshen Fang'' combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Diabetes Nephropathy: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medicine in the Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069269
Enrollment
Unknown
Registered
2023-03-10
Start date
2023-03-10
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Type 2 diabetes kidney disease

Interventions

Experimental group:Tangshen Fang+Standard Western Medicine±Traditional Chinese Medicine
Control group:Standard Western Medicine±Traditional Chinese Medicine

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Clearly diagnosed type 2 diabetes; Glycosylated hemoglobin =30mg/g, or eGFR: 25 ~ <60 ml/min/(1.73m^2) with UACR<30mg/g; And last for more than 3 months; 4. TCM syndrome differentiation mainly consists of Qi and Yin deficiency with blood stasis; 5. Sign informed consent and cooperate with follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Patients with severe diabetes and major vascular events within six months; 2. Various infections within four weeks; 3. Combined use of Uiduqing Granules and Shenshuaining capsules; 4. Pregnant or lactating patients who are allergic to the test drug; 5. Complicated with other serious diseases, such as blood system diseases, malignant tumors, severe heart failure, obvious liver diseases; 6. Uncontrolled hypertension (SBP>=160 mmHg and/or DBP>=100 mmHg); 7. Patients with mental illness or incapacity; 8. Kidney disease not caused by diabetes has been identified; 9. Hyperkalemia (blood potassium > 5.5mmol/L).

Design outcomes

Primary

MeasureTime frame
Change in eGFR levels from baseline to week 24;

Secondary

MeasureTime frame
Urine protein/creatinine ratio (UACR) from baseline at 24 weeks;Change in body weight from baseline to week 24;Change in body blood pressure(systolic and diastolic) from baseline to week 24;Change in fasting lipid profile (TC, LDL-C, HDL-C, TG) from baseline to week 24;Change in fasting plasma glucose from baseline to week 24;Change in HbA1c from baseline to week 24;Improvement in TCM symptoms(evaluated by TCM symptom assessment score)from baseline to week 24;Improvement in quality of life from baseline to week 24;Change in waist circumference from baseline to week 24;

Countries

China

Contacts

Public ContactChen Xiaoping

China-Japan Friendship Hospital

chenxp1995@163.com+86 186 1153 3402

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026