Status:
UNKNOWN
Post-marketing Evaluation of Mudan Granule Intervention on Type 2 Diabetic Peripheral Neuropathy
Lead Sponsor:
Fengmei Lian
Collaborating Sponsors:
Peking Union Medical College Hospital
Beijing Hospital
Conditions:
Diabetic Peripheral Neuropathy Type 2
Eligibility:
All Genders
30-70 years
Phase:
EARLY_PHASE1
Brief 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, a...
Detailed Description
1. Research objective: To evaluate the efficacy and safety of Mudan granule combined with methylcobalamin in the treatment of type 2 diabetic peripheral neuropathy, providing the highest level of evid...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria of type 2 diabetic peripheral neuropathy.
- Meet the diagnostic criteria of TCM syndrome differentiation of qi deficiency and collaterals obstruction.
- The patient's age is between 30-70 years.
- At least 2 nerve conduction velocities have decreased on electromyography.
- Sign informed consent.
Exclusion
- 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.
- 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.
- Systolic blood pressure \> 160 millimeters of mercury (mmHg) or diastolic blood pressure \> 100mmHg.
- Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.
- 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.
- Pregnancy, prepared to pregnant or lactating women.
- Having a history of multiple drug allergies or being allergic to the ingredients of Mudan granule.
- Participate in other clinical studies within one month.
- Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and dependents over the past five years.
- Having a history of active ophthalmopathy,ocular surgery,glaucoma,acute and chronic corneal diseases,extended-wearing contact lens and so on.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04711980
Start Date
June 1 2021
End Date
September 1 2022
Last Update
January 15 2021
Active Locations (1)
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1
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, China