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

Early Phase 1

• Conditions: Diabetic Kidney Disease
• Interventions: Drug: Tangshen Prescription; Drug: Placebos

• Registration Number: NCT03009864
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief 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.

Detailed Description

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/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 study will last for 24 weeks. Subjects will be randomly divided into two groups, either tang shen prescription or placebo，and both of them would be performed on a basic treatment which includes diabetes education, diabetic diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested monthly, and quantity of 24h urinary protein per three months.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2019-09
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 632

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tangshen Prescription	Tangshen Prescription	The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Tangshen Prescription	Placebos	The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Placebo	Placebos	Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.
Placebo	Tangshen Prescription	Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.

Primary Outcome Measures

Name	Time	Method
changes of albumin-to-creatinine ration	0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

Secondary Outcome Measures

Name	Time	Method
number of participants of diabetic kidney disease in macroalbuminuria stage	0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
number of participants whose microalbuminuria excretion rate < 20ug/min	0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
change of GFR	0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
the rate of doubling the baseline with serum creatinine value	0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China