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Study on accurate diagnosis and treatment of qi deficiency and blood stasis syndrome of diabetes kidney disease and intervention of Shenzhuo recipe based on SNP and uromics

Study on accurate diagnosis and treatment of qi deficiency and blood stasis syndrome of diabetes kidney disease and intervention of Shenzhuo recipe based on SNP and uromics

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006564
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-09-05
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Diabetes and kidney disease

Interventions

Simple standard basic treatment group:Simple standard basic treatment
Traditional Chinese medicine Shenzhuo recipe combined with standard basic treatment group:Traditional Chinese medicine Shenzhuo recipe combined with standard basic treatment
Non-qi deficiency and blood stasis syndrome group: Simple standard basic treatment

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy people (1) It meets the diagnostic criteria of healthy people, and the constitution of traditional Chinese medicine is judged to be mild; (2) Age: 18-70 years old; (3) Blood glucose is within the normal range; (4) Those who sign the informed consent form. Inclusion criteria of qi deficiency and blood stasis syndrome (1) Those who meet the diagnostic criteria of diabetes nephropathy in traditional Chinese medicine and the syndrome differentiation type is Qi deficiency and blood stasis syndrome, and those who meet the diagnostic criteria of diabetes kidney disease in western medicine and the renal function stage is g2-g3a, and the proteinuria stage is A2-A3. (2) The fasting blood glucose of the patients is less than 8.0mmol/l, the blood glucose at 2h after meal is less than 11.0mmol/l, and the glycosylated glycemic protein is less than 8.0%, which can be relaxed to 8.5% in the elderly patients. (3) The patient's blood pressure is not controlled or after taking antihypertensive drugs, the control is greater than 130 / 80mmHg, the diastolic blood pressure is not less than 70mmhg, and the diastolic blood pressure of elderly patients is not less than 60mmhg. (4) Patients aged 40 years or older and 75 years or younger. (5) The patient was informed and agreed to participate in this study. Inclusion criteria of non Qi deficiency and blood stasis syndrome (1) Those who meet the diagnostic criteria of diabetes nephropathy in traditional Chinese medicine and the syndrome differentiation type is damp heat syndrome, and those who meet the diagnostic criteria of diabetes kidney disease in western medicine and the renal function stage is g2-g3a, and the proteinuria stage is A2-A3. (2) The fasting blood glucose of the patients is less than 8.0mmol/l, the blood glucose at 2h after meal is less than 11.0mmol/l, and the glycosylated glycemic protein is less than 8.0%, which can be relaxed to 8.5% in the elderly patients. (3) The patient's blood pressure is not controlled or after taking antihypertensive drugs, the control is greater than 130 / 80mmHg, the diastolic blood pressure is not less than 70mmhg, and the diastolic blood pressure of elderly patients is not less than 60mmhg. (4) Patients aged 40 years or older and 75 years or younger. (5) The patient was informed and agreed to participate in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy people (1) Patients with respiratory system, digestive system, endocrine system, cardiovascular system and other diseases during diagnosis; (2) Mental patients; (3) Women who are pregnant, preparing for pregnancy or breastfeeding. Exclusion criteria of qi deficiency and blood stasis syndrome (1) Those who do not meet the diagnostic criteria and inclusion criteria of patients with Qi deficiency and blood stasis syndrome; (2) Patients with type 1 diabetes and kidney disease; (3) Patients with acute and severe diseases such as diabetes ketosis, ketoacidosis, hyperosmolar coma, and severe infection were not corrected before enrollment; (4) Patients with severe heart, liver and kidney dysfunction or malignant tumors; (5) Allergic constitution, patients during pregnancy or lactation, or those who have a history of allergy to various traditional Chinese medicines. Exclusion criteria of non Qi deficiency and blood stasis syndrome (1) Those who do not meet the diagnostic criteria and inclusion criteria of damp heat syndrome; (2) Patients with type 1 diabetes and kidney disease; (3) Patients with acute and severe diseases such as diabetes ketosis, ketoacidosis, hyperosmolar coma, and severe infection were not corrected before enrollment; (4) Patients with severe heart, liver and kidney dysfunction or malignant tumors; (5) Allergic constitution, patients during pregnancy or lactation, or those who have a history of allergy to various traditional Chinese medicines.

Design outcomes

Primary

MeasureTime frame
SNPs;24h urine protein quantification;Urine Proteomics;Urinary albumin to creatinine ratio;Biochemical full item;glomerular filtration rate;glycosylated hemoglobin;Urine metabolomics;

Secondary

MeasureTime frame
TCM syndrome score;blood fat;uric acid;

Countries

China

Contacts

Public ContactLimin

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limin-72114@163.com13261029206

Outcome results

None listed

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