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Clinical observation and mechanism study of Baihu Erzhi Tang in treating stage III diabetic kidney disease with heat and yin deficiency

Clinical observation and mechanism study of Baihu Erzhi Tang in treating stage III diabetic kidney disease with heat and yin deficiency

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093405
Enrollment
Unknown
Registered
2024-12-04
Start date
2024-05-21
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Diabetic kidney disease

Interventions

Control Group:Conventional Western Medicine Treatment Options
Treatment Group:Bai Hu Er Zhi Tang Chinese Medicine Granules

Sponsors

Beijing Shijitan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Definite history of type 2 diabetes mellitus, the diagnosis meets the diagnostic criteria of Western medicine for diabetic nephropathy, and the stage is DKD stage III.; 2. The TCM syndrome type is diagnosed as the hot and yin deficiency type; 3. Age 18-75 years old, male or female; 4. Those who adopt a stable treatment plan that meets the standards of the guidelines for the prevention and treatment of type 2 diabetes, and achieve the comprehensive treatment goals recommended by the guidelines, and do not need to adjust the treatment plan; 5. Receiving a stable dose of medication for 8 consecutive weeks prior to enrollment to control hypertension, hyperglycemia and dyslipidemia (if applicable); 6. Angiotensin-converting enzyme inhibitor (ACE inhibitor) or angiotensin II receptor blocker (ARB) dose was stable for 8 weeks before enrollment; 7. Able to understand and comply with the study process, voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergy to the test drug or related drugs; 2. Patients with type I diabetes mellitus; 3. Females who are pregnant, breastfeeding, or planning to become pregnant, or females of childbearing potential who are not taking highly effective contraceptive measures; 4. Patients with serious primary diseases such as heart, brain, liver and hematopoietic system; 5. Acute metabolic disorder or ketoacidosis in the past 1 month; 6. Patients with acute renal failure, urinary tract infection, menstrual period, intense exercise, cold and other stress states or mental patients; 7. Those who have poor compliance and cannot complete the test according to the protocol.

Design outcomes

Primary

MeasureTime frame
CM syndrome score;

Secondary

MeasureTime frame
Urinary albumin / creatinine ratio;Estimated glomerular filtration rate;

Countries

China

Contacts

Public ContactMin Jiang

Beijing Shijitan Hospital Affiliated to Capital Medical University

jiangm1965@sina.com+86 133 1110 8797

Outcome results

None listed

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