Post-marketing Evaluation of Mudan Granule Intervention on Type 2 Diabetic Peripheral Neuropathy

Summary

Background: Diabetic peripheral neuropathy (DPN) is a common and disabling chronic microvascular complications in patients with type 2 diabetic Mellitus (T2DM) that is characterized by nerve damage, affecting at least half of patients diagnosed with diabetes. It has been reported that DPN significantly contributes to the increased morbidity with diabetic foot ulcers by 60% and amputation by 85% that seriously threaten the quality of life. Mudan granule, a traditional Chinese medicinal preparation, is widely used in clinical practice for DPN in China. Evidence from clinical and preclinical studies have shown that Mudan granule could relieve symptoms and reduce the incidence of DPN exacerbations. However, the previous studies are of variable quality and poorly standardized,which limits the clinical application of Mudan granule. This study evaluates the efficacy and safety of Mudan granule combined with methylcobalamin in the treatment of type 2 diabetic peripheral neuropathy, providing the highest level of evidence of Mudan granule.

Methods and design: A randomized, double-blind, placebo-controlled,parallel-arm, and multi-centric clinical trial design was used based on a co-regimen of methylcobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Mudan granule combined with methylcobalamin, and the patients in the control group were treated with placebo combined with methylcobalamin. The total intervention period is 24 weeks. The sample size was 402 cases.

Major evaluation indicators: Michigan Diabetic Neuropathy Score (MDNS) changes, the changes of MDNS were compared between the two groups before and after medication, adopting the evaluation method of difference values. Secondary Evaluation Indicators:(1) nerve conduction velocity changes, the changes in nerve conduction velocity of each nerve were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (2)corneal nerve fiber density changes, the changes in corneal nerve fiber density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (3)corneal nerve branch density changes, the changes in corneal nerve branch density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (4)corneal nerve fiber length changes, the changes in corneal nerve fiber length of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (5)Toronto Clinical Scoring System (TCSS) changes, the changes of toronto clinical score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (6)Traditional Chinese Medicine(TCM) syndromes efficacy score changes, the changes in TCM syndromes efficacy score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (7) Clinical symptoms score changes, the changes of each of clinical symptoms score were compared between the two groups before and after medication, adopting the evaluation method of difference values.

Discussion: We postulate that patients with type 2 diabetic peripheral neuropathy will benefit from therapy with Mudan granule.

Conditions

• Diabetic Peripheral Neuropathy Type 2

Interventions

DRUG

Mudan granule

Mudan granule,a traditional Chinese medicine formula,consists of nine 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 Mudan granule in appearance, colour, taste. Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• The Fourth People's Hospital of Chongqing

  collaborator UNKNOWN

• Zhengzhou Yihe Hospital Affiliated to Henan University

  collaborator UNKNOWN

• Zhu Xianyi Memorial Hospital of Tianjin Medical University

  collaborator UNKNOWN

• The Third Hospital of Xi'an

  collaborator UNKNOWN

• Huashan Hospital

  collaborator OTHER

• Gansu Provincial People's Hospital

  collaborator UNKNOWN

• Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Affiliated Hospital of Changchun University of Chinese Medicine

  collaborator OTHER

• Fengmei Lian

  lead OTHER

Principal Investigators

• Xin hua Xiao, Ph.D. · Peking Union Medical College Hospital

• Yi Li, Ph.D. · Beijing Hospital

• Shi jia Yu, Ph.D. · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• Yan gang Wang, Ph.D. · The Affiliated Hospital of Qingdao University

• Qiu Chen, Ph.D. · Chengdu University of Traditional Chinese Medicine

• Wu quan Deng, Ph.D. · The Fourth People's Hospital of Chongqing

• Zhi gang Zhao, Ph.D. · Zhengzhou Yihe Hospital Affiliated to Henan University

• Zhen qiang Song, Ph.D. · Zhu Xianyi Memorial Hospital of Tianjin Medical University

• Ping Liu, Master · The Third Hospital of Xi'an

• Yi ming Li, Ph.D. · Huashan Hospital

• Jing Liu, Ph.D. · Gansu Provincial People's Hospital

• Chun Li Piao, Ph.D. · Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine

• Xiu ge Wang, Master · Affiliated Hospital of Changchun University of Chinese Medicine

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

2021-06-30

Primary Completion

2022-02-28

Completion

2022-09-30

Countries

• China

Study Locations