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Clinical observation of Tangshen Dihuang Decoction in the treatment of kidney yin deficiency type diabetic nephropathy and its mechanism of action on intestinal flora

Clinical observation of Tangshen Dihuang Decoction in the treatment of kidney yin deficiency type diabetic nephropathy and its mechanism of action on intestinal flora

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000150
Enrollment
Unknown
Registered
2026-01-24
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Diabetic nephropathy

Interventions

Losartan group:Losartan potassium 100mg once daily orally.
Bifidobacterium + Losartan Potassium group:Bifidobacterium triple live bacteria capsules, 2 capsules twice daily orally + Losartan potassium 100mg once daily orally.
Traditional Chinese medicine + Losartan potassium group:Traditional Chinese medicine twice daily (oral administration) + Losartan potassium 100mg once daily orally.

Sponsors

Shanghai Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age between 40 and 75 years old. (2) Meeting the diagnostic criteria. (3) Diagnosed as having kidney yin deficiency syndrome by two traditional Chinese medicine practitioners. (4) Systolic blood pressure controlled below 140 mmHg and diastolic blood pressure below 90 mmHg. (5) Generally healthy with no history of major diseases. (6) Willing to accept this treatment and observation, and having signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes leading to early kidney damage. (2) Patients with severe primary diseases of the heart, brain, liver, and hematopoietic system. (3) Patients with kidney damage not caused by diabetes, such as hypertensive nephropathy, glomerulonephritis, urinary tract infections, and other causes. (4) Patients allergic to this medication. (5) Patients with cognitive impairment or those unable to care for themselves. (6) Other conditions or diseases that the researchers believe may pose significant risks to the patient or confound the study results, and therefore warrant exclusion.

Design outcomes

Primary

MeasureTime frame
Urinary microalbumin;24-hour urine protein quantification;Renin;Angiotensin II;gut microbiota;

Secondary

MeasureTime frame
Kidney function;glomerular filtration rate;Fasting blood glucose;Blood glucose level 2 hours after a meal;Glycated hemoglobin;Traditional Chinese Medicine Syndrome Scoring;BMI;

Countries

china

Contacts

Public Contactyangchaomao

Shanghai Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine

yang_chaomao@126.com13817307795

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026