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

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.

Conditions

• Diabetic Kidney Disease

Interventions

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

  collaborator OTHER

• Zhengzhou City Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Shijiazhuang City Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Baoding City Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Changchun Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Xingtai City Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Medicine Zibo Wanjie Tumor Hospital

  collaborator UNKNOWN

• Zouping Country Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• She Country Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Beijing Hospital of TCM

  collaborator UNKNOWN

• Baishi Hospital

  collaborator UNKNOWN

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-09-30

Completion

2020-05-31

Countries

• China

Study Locations