Clinical observation of external treatment with integrated Traditional Chinese and Western medicine on diabetic peripheral neuropathy

Phase 1

Recruiting

• Conditions: Diabetic peripheral neuropathy

• Registration Number: ITMCTR2200005563
• Lead Sponsor: onghua Hospital affiliated to Shanghai University of 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 meeting the diagnostic criteria of diabetic peripheral neuropathy and TCM syndrome differentiation criteria;
(2) Aged between 18 and 80;
(3) HBA1c =10%, or fasting blood glucose =10mmol/L, 2h postprandial blood glucose =16mmol/L;
(4) Have enough education and understanding ability, and can easily communicate with researchers;
(5) Agree to keep the contract to participate in all clinical interview, examination and test steps required by the program, and sign the informed consent letter.

Exclusion Criteria

(1) suffering from mania, bipolar disorder or mental illness;
(2) have severe or unstable cardiovascular, liver, kidney, respiratory, or hematological disorders, symptomatic peripheral vascular diseases, or other physical disorders (including unstable hypertension) or psychological disorders that the investigator considers to be affecting study participation or likely to result in hospitalization during the study;
(3) have used drugs that are known to cause neuropathy (e.g., vincristine) and have suffered from diseases that may cause neuropathy, such as pernicious anaemia and hypothyroidism;
(4) Patients suffering from skin diseases or skin damage of limbs;
(5) Previous history of eye surgery;
(6) chronic inflammatory demyelinating polyneuropathy, cervical and lumbar lesions, cerebral infarction or Guillain-Barre syndrome;
(7) pregnant and lactating women;
(8) The staff of the research institution and their immediate family members who are directly related to the research;
(9) Unable to fill in various scales, or unwilling to be randomly grouped;
(10) patients who are participating in other clinical trials.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Michigan Neuropathy Screening Scale;Serum superoxide dismutase;Quality of life specific scale for diabetic patients;electromyography;The doctor of traditional Chinese medicine syndrome;