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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Drug: Tangshen Prescription; Drug: Placebos

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 Type: Interventional
• Enrollment (Anticipated): 632
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Drug: 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_COMPARATOR: Placebo; 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.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes of albumin-to-creatinine ration	0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (ESTIMATE): January 4, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: RCT; Diabetic Kidney Disease; TCM
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: 201507001-11Tangshen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED