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Clinical Study of Huangqi Decoction/Astragalus Decoction in the Treatment of 'Qi-Yin Vital Essence Deficiency' Type DKD III Patients

Clinical Study of Huangqi Decoction/Astragalus Decoction in the Treatment of 'Qi-Yin Vital Essence Deficiency' Type DKD III Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008847
Enrollment
Unknown
Registered
2016-07-15
Start date
2015-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Diabetic nephropathy

Interventions

astragalus decoction andvalsartan group:astragalus decoction, valsartan
valsartan andthe placebo:valrtan,placebo

Sponsors

Shanghai Putuo District Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Exact 2 type diabetes history; 2. TCM syndrome differentiation: Qi-Yin vital essence deficiency patients; 3. Blood pressure is controlled under 140/90 mmHG, glycosylated hemoglobin < 7%, at the me time, GFR =60 ml/min/1.73 m2; 4. Lead period: drug regulation: high blood pressure drugs: for patients with high blood pressure, CCB category preparation is the first choice drug. If the blood pressure cannot be controlled in the targeted range, add antihypertensive drugs such as central or receptor antagonists. Do not take ACEI ARB categories antihypertensive drugs. Mean, do not take other Chinese medicine Chinese patent medicine which has the function of lowering protein. 2 weeks lead period, at the ning the end of the lead period, patients need conduct the following tests patients meet these two standards can enter the trial period: (1) Urinary albumin creatinine ratio: 30-300mg/mmol; (2) blood pressure to be controlled in the range of 90/60 mmHg to 140/90mmHg; (3) Fasting blood-glucose 3.8 to 7.8 mmol/L or non-fasting blood glucose=11.1mmol/L; 5. Aged 18 -75 years old; 6. Patients accept this drug treatment voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1) I Type diabetic; 2) Patients combined with severe primary diseases in heart, brain, liver hematopoietic tems; 3) Patients with diabetes mellitus ketoacidosis acute metabolic disorders within a month; 4) Acute renal failure patients combined with urinary tract infection, menstrual period, strenuous exercise, catch cold other stress states; 5) Psychotic, pregnant or lactating women; 6) Patients with known drug allergies; patients are participating in other drug clinical trials or have participated in other trails within 3 months.

Design outcomes

Primary

MeasureTime frame
UACR;eGF;

Secondary

MeasureTime frame
Scr;BUN;BUA;GFR;24-hour urinary protein quantity;Fasting plasma glucose;Postprandial blood glucose 2 h;Fasting c-peptide;Postprandial 2 h C peptide;Glycated hemoglobin;

Countries

China

Contacts

Public ContactWang Yunman

Shanghai Putuo district Central Hospital

415249408@qq.com+86 021 22233222-58163

Outcome results

None listed

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