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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03009864
• Other study ID #: 201507001-11Tangshen
• Status: Not yet recruiting
• Phase: Phase 0
• First received: January 2, 2017
• Last updated: January 3, 2017
• Start date: January 2017
• Est. completion date: May 2020

Study information

• Verified date: January 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Fengmei Lian, PHD
• Phone: 0086-010-88001402
• Email: lfm565[@]sohu.com
• Is FDA regulated: No
• Health authority: Guang`anmen Hospital Medical Ethics Committee:Beijing
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 632
• Est. completion date: May 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (13)

Lead Sponsor

Collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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, Xingtai City Hospital of Traditional Chinese Medicine, Zhengzhou City Hospital of Traditional Chinese Medicine, Zouping Country Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of albumin-to-creatinine ration		0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks	No
Secondary	number of participants of diabetic kidney disease in macroalbuminuria stage		0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks	No
Secondary	number of participants whose microalbuminuria excretion rate < 20ug/min		0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks	No
Secondary	change of GFR		0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks	No
Secondary	the rate of doubling the baseline with serum creatinine value		0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks	No