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Clinical Synergism and Metabolic Mechanism of Rehmannia Leaf Total Glycosides Capsule Combined with Valsartan in the Treatment of Diabetic Nephropathy

Clinical Synergism and Metabolic Mechanism of Rehmannia Leaf Total Glycosides Capsule Combined with Valsartan in the Treatment of Diabetic Nephropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118464
Enrollment
Unknown
Registered
2026-02-05
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Diabetic nephropathy

Interventions

Control group:Receive the standard Western medicine treatment plan, including regular management of blood sugar, blood pressure and blood lipids: Hypoglycemic treatment: Metformin Hydrochloride (Appro
Experimental group:On the basis of this standardized background treatment, the patients in the observation group were given Dihuangye total glycoside capsule (National Medicine Zhunzi Z20070051, Sichu

Sponsors

Tangshan Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Western medicine diagnostic criteria: Refer to the diagnostic criteria for diabetic nephropathy in the "Diagnosis Criteria for Diabetic Nephropathy (2010)": Fasting blood glucose >= 7.0 mmol/L or 2-hour post-meal blood glucose >= 11.1 mmol/L), and meet any of the following conditions: Persistent microalbuminuria: Urinary albumin excretion rate (UAER) is in the range of 20-200 µg/min (or urinary albumin/muscle creatinine ratio is 30-300 mg/g), and positive results are obtained from repeated tests within at least 3 months; Manifest proteinuria: 24-hour urine protein total > 500 mg; Renal function impairment: Elevated serum creatinine (SCr) accompanied by decreased glomerular filtration rate (eGFR). Traditional Chinese medicine diagnostic criteria: Main symptoms: Edema; Urinary turbidity; Weakness and soreness in the waist and knees; Fatigue and weakness. Secondary symptoms: Dry mouth and throat; Cold limbs; Frequent nocturnal urination; Dark complexion. The patient must meet all the main symptoms and any 2 of the secondary symptoms, and the above-mentioned changes in tongue coating and tongue texture can be used for diagnosis. Inclusion criteria: Meet the aforementioned Western medicine and traditional Chinese medicine diagnostic criteria; Diabetes history >= 5 years; 24-hour urine protein quantification > 0.5 g; Organ functions: No obvious abnormalities in major organs such as the heart, liver, and kidneys.

Exclusion criteria

Exclusion criteria: Patients with high filtration stage nephropathy; Complicated with acute cardiovascular and cerebrovascular events or malignant tumors; Those who have a history of allergy to the study drugs; Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Efficacy rating;Renal function index;

Secondary

MeasureTime frame
Metabonomics research methods;

Countries

China

Contacts

Public ContactZhang Guojiang

Tangshan Hospital of Traditional Chinese Medicine

2261955928@qq.com+86 315 873 6161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026