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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

1. Meet the diagnostic criteria of type 2 diabetic peripheral neuropathy.

2. Meet the diagnostic criteria of TCM syndrome differentiation of qi deficiency and collaterals obstruction.

3. The patient's age is between 30-70 years.

4. At least 2 nerve conduction velocities have decreased on electromyography.

5. Sign informed consent.

Exclusion Criteria:

1. Recent use of antioxidants such as vitamin E or vitamin C, acute infection, liver and kidney dysfunction, acute complications of diabetes, severe cardiovascular and cerebrovascular diseases,neuropathy caused by long-term alcohol consumption and other factors.

2. Besides methylcobalamin,the drugs such as alpha lipoic acid, epalrestat, VitB12, Chinese patent medicine and decoction have been used to treat diabetic peripheral neuropathy within 4 weeks before enrollment.

3. Systolic blood pressure > 160 millimeters of mercury (mmHg) or diastolic blood pressure > 100mmHg.

4. Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.

5. Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary disease, serum transaminase beyond the normal value more than 2 times, serum creatinine greater than the upper limit of normal, psychiatric patients.

6. Pregnancy, prepared to pregnant or lactating women.

7. Having a history of multiple drug allergies or being allergic to the ingredients of Mudan granule.

8. Participate in other clinical studies within one month.

9. Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and dependents over the past five years.

10. Having a history of active ophthalmopathy,ocular surgery,glaucoma,acute and chronic corneal diseases,extended-wearing contact lens and so on.