Randomized, controlled, multicentral clinical observation of activating blood circulation and removing blood stasis, Promoting Qi and nourishing Yin in the treatment of diabetic nephropathy and study on the mechanism of cell signaling pathway

Phase 4

Recruiting

• Conditions: Diabetic Kidney Diease

• Registration Number: ITMCTR2100004881
• Lead Sponsor: 416 Hospital of Nuclear Industry, the Second Affiliated Hospital of Chengdu Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Meet the diagnostic criteria of type 2 diabetes and diabetic nephropathy in western medicine;
2.24h urine protein quantitative 0.5g/24h to 3.0g/24h;
3.eGFR is 15ml/min/1.73m2~59ml/min/1.73m2 (calculated by CKD-EPI formula);
4.Fasting blood glucose <13.9mmol/L and/or 2 hours postprandial blood glucose <16.6mmol/L;
5.HbA1c<=10%;
6.Aged 35 to 75 years;
7.Sign the informed consent form voluntarily.

Exclusion Criteria

1. Simple nephrogenic hematuria or proteinuria with hematuria, or normal renal function but sudden edema and massive proteinuria, significant renal tubular dysfunction, combined with obvious abnormal tubular type, primary glomerulonephritis or Secondary nephritis except diabetic nephropathy, acute and chronic urinary system infection;
2. Severe cardiovascular disease occurred within three months: a history of myocardial infarction, or ischemic heart disease and congestive heart failure that have undergone coronary bypass or PCI surgery (heart function grade III-IV, NYHA rating) Patients, or patients with severe cerebrovascular disease (stroke and significant neurological dysfunction remaining after stroke);
3. Combined with liver, hematopoietic system, endocrine system, respiratory system and other serious systemic primary diseases and dysfunctions
Patients: ALT, AST>2.5 times the upper limit of normal;
4. Chronic diarrhea is defined as increased frequency of bowel movements (>3 times/day), increased stool volume, thin stools, diarrhea for more than 3 to 6 weeks or recurrent episodes;
5. Those who have had active bleeding within three months;
6. Abnormal blood coagulation function;
7. People with a history of alcohol abuse, drug abuse or mental illness;
8. Women who are pregnant, breastfeeding or planning to become pregnant during the study period;
9. Those who have participated in other clinical trials within the past 3 months;
10. The investigator believes that others are not suitable to participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beclin-1;LC3-II;mammalian target of rapamycin, mTOR);