A multi-center, randomized, double-blind, placebo-controlled, trial of Baimai Ointment in the intervention of diabetic distal symmetric polyneuropathy

Phase 4

Recruiting

• Conditions: Diabetic distal symmetric polyneuropathy

• Registration Number: ITMCTR2000003843
• Lead Sponsor: Xuanwu Hospital of Capital Medical University

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 of diabetic DSPN;
2. Patients with HbA1c below 9%, or fasting blood glucose < 8 mmol / L, 2 h postprandial blood glucose < 15 mmol / L;
3. Subjects whose aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than 2 ULN;
4. Subjects whose serum creatinine is less than 1.5 ULN;
5. Aged 30 to 75 years;
6. Those who agree to participate in all clinical interviews, examinations and test procedures required by the protocol and sign informed consent.

Exclusion Criteria

1. Patients with other types of diabetic peripheral neuropathy except DSPN;
2. Patients who have taken anti oxidative stress drugs such as vitamin E or vitamin C within 6 months after signing the informed consent form;
3. Patients who have taken traditional Chinese medicine and Tibetan medicine to treat the disease within 3 months after signing the informed consent form;
4. Patients with clinically significant unstable neurological, ocular, hepatobiliary, respiratory, hematological or unstable cardiovascular diseases (e.g., severe hypotension, uncontrollable arrhythmia or myocardial infarction) within 12 months before screening;
5. Patients with hepatic and renal insufficiency (AST, ALT >= 2 times of normal upper limit, serum creatinine >= 1.5 times of normal upper limit or other liver and kidney dysfunction judged by researchers);
6. Patients with neuropathy caused by cardiovascular and cerebrovascular diseases, long-term drinking and other factors;
7. Patients with acute complications of diabetes; patients with diabetic ketosis, ketoacidosis and severe infection within one month before signing the contract;
8. Patients with intermittent claudication, ulcer of lower limbs or skin damage;
9. Pregnant, ready for pregnancy or lactation women;
10. People who are known to be allergic to the test drug; and patients with allergic constitution;
11. The patients whose blood glucose was not controlled within one month before randomization;
12. Patients who have participated in clinical studies of other drugs or are participating in other clinical studies or have used the trial drug within one month before signing the informed consent form;
13. Patients with history of alcoholism and other drug abuse (alcohol standard: men drink more than 50 grams of alcohol a day, women drink more than 30 grams of alcohol a day; drug abuse history is judged by clinical symptoms and medication history);
14. Subjects who are known to be positive for HIV, HBV or HCV;
15. Patients who have been using Mecobalamin for more than 3 months before signing the informed consent form;
16. Patients who still use nutritional nerve drugs except Mecobalamin tablets after signing informed consent form;
17. The subjects considered unsuitable for clinical trials included those with poor compliance judged by researchers, loss of follow-up due to frequent changes in working environment, and failure to give full informed consent due to mental and behavioral disorders.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Total score changes of Michigan Diabetic Peripheral Neuropathy Score (MDNS);