The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment with either tang shen prescription or placebo.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Anhui Provincial Hospital of Traditional Chinese Medicine; Baishi Hospital; Baoding City Hospital of Traditional Chinese Medicine; Beijing Hospital of TCM; Changchun Hospital of Traditional Chinese Medicine; Hubei Hospital of Traditional Chinese Medicine; Medicine Zibo Wanjie Tumor Hospital; She Country Hospital of Traditional Chinese Medicine; Shijiazhuang City Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Xingtai City Hospital of Traditional Chinese Medicine; Zhengzhou City Hospital of Traditional Chinese Medicine; Zouping Country Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. Diagnosis of type 2 diabetic Kidney Disease in early stage;

2. Aged 30-70;

3. Signed the informed consent.

Exclusion Criteria:

1. Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.

2. Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the serum transaminase was two times larger than the normal valuet、serum creatinine concentration greater than the upper limit of normal value and psychiatric disease.

3. Women with Pregnancy or prepare for pregnancy or lactating.

4. Degree of renal failure have developed to the stage of hypoxemia and uremia.

5. Patients participate in other clinical researchers within a month.

6. Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month.

7. Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month.

8. Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.

9. Patients with diabetic ketosis, ketoacidosis and severe infections within a month.

10. Patients addicting alcohol, psychoactive substances within 5 years.

11. According to the researcher's judgment, there are other diseases or situations that can reduce the possibility of entering the group or complicate the group, such as frequent changes in the working environment and unstable living environment.