Clinical efficacy of traditional chinese medicine combined with mecobalamin in the treatment of diabetic peripheral neuropathy

Phase 1

Recruiting

• Conditions: Diabetic peripheral neuropathy

• Registration Number: ITMCTR1900002293
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients who meet the diagnostic criteria for diabetic peripheral neuropathy;
(2) Aged 18-75 years (including 18 and 75 years);
(3) Glycated hemoglobin = 10%, or fasting blood glucose = 10mmol / L, blood glucose = 16mmol / L 2h after meal;
(4) Have sufficient education and understanding and can easily communicate with researchers;
(5) Agree to comply with all clinical interviews, examinations and test procedures required by this program and sign the informed consent form.

Exclusion Criteria

(1) Diseases such as mania, bipolar disorder, cognitive dysfunction, etc. that the investigators believe may affect the experimental fit;
(2) Suffering from severe or unstable cardiovascular and cerebrovascular diseases, liver, kidney, respiratory, hematological or malignant diseases, or cervical and lumbar disease, Guillain-Barré syndrome, or researchers believe that in research The process may affect other physical illnesses (including unstable hypertension) or mental illnesses that participate in the study or may result in hospitalization;
(3) Drugs that have been used to cause neuropathy have been used, and have suffered from diseases that may cause neuropathy;
(4) Patients with blindness, low vision or amblyopia;
(5) Pregnant and lactating women;
(6) Research unit personnel directly related to the research and their immediate family members;
(7) Unable to complete the filling of various scales, or unwilling to be randomly grouped;
(8) Patients who are participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vertical position blood pressure changes;MNSI;Heart rate variability;Nerve conduction velocity;Deep breathing heart rate change;