Clinical trial NCT03009864: The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Official title: The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease
TCM
RCT
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Zhengzhou City Hospital of Traditional Chinese Medicine
name: Shijiazhuang City Hospital of Traditional Chinese Medicine
name: Baoding City Hospital of Traditional Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: Changchun Hospital of Traditional Chinese Medicine
name: Xingtai City Hospital of Traditional Chinese Medicine
name: Medicine Zibo Wanjie Tumor Hospital
name: Zouping Country Hospital of Traditional Chinese Medicine
name: She Country Hospital of Traditional Chinese Medicine
name: Beijing Hospital of TCM
name: Baishi Hospital
First posted: 2017-01-04
Enrollment: 632
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: changes of albumin-to-creatinine ration
timeFrame: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Secondary outcomes:
measure: number of participants of diabetic kidney disease in macroalbuminuria stage
timeFrame: 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
measure: number of participants whose microalbuminuria excretion rate < 20ug/min
timeFrame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
measure: change of GFR
timeFrame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
measure: the rate of doubling the baseline with serum creatinine value
timeFrame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References:
citation: Jin D, Huang WJ, Meng X, Yang F, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial. Trials. 2019 Dec 21;20(1):756. doi: 10.1186/s13063-019-3821-6.