The Multi-Centric Clinical Study of Chinese Medicine Intervention on Diabetes Distal Symmetric Polyneuropathy.

Summary

Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2 diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than 60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We postulate that patients with DSPN will benefit from therapy with TCM treatment according to syndrome differentiation.

Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Tangbi prescription, and the patients in the control group were treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication. Secondary Evaluation Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.② Clinical symptoms and signs change, The clinical symptoms and signs of the patients were compared before and after taking the medicine.

Discussion: We postulate that patients with DSPN will benefit from therapy with TCM treatment.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Tangbi (prescription)

A kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).

DRUG

Placebo

Granule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste. Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).

Sponsors & Collaborators

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

  collaborator OTHER

• Zhengzhou City Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  collaborator OTHER

• Hebei Yiling Hospital

  collaborator OTHER

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• 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

2019-11-30

Completion

2020-05-31