Post-marketing Evaluation of Mudan Granule Intervention on Type 2 Diabetic Peripheral Neuropathy
Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Fengmei Lian
Collaborators:
Affiliated Hospital of Changchun University of Chinese Medicine Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Affiliated Hospital of Qingdao University Beijing Hospital Chengdu University of Traditional Chinese Medicine Gansu Provincial People's Hospital Huashan Hospital Peking Union Medical College Hospital Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine The Fourth People's Hospital of Chongqing The Third Hospital of Xi'an Zhengzhou Yihe Hospital Affiliated to Henan University Zhu Xianyi Memorial Hospital of Tianjin Medical University