Diabetic peripheral neuralgia
Conditions
Interventions
240mg:Eight subjects were included in each group to receive the experimental drug, and two subjects were included in the placebo-controlled trial. Frequency and cycle: D1 1 time per day
D3-d11 was administered twice a day, once in the morning and once in the evening, and the interval between the two adjacent&
480mg:Eight subjects were included in each group to receive the experimental drug, and two subjects were included in the placebo-controlled trial. Frequency and cycle: D1 1 time per day
Sponsors
Xiangya Second Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Screening age: 18-70 years old patients, including the threshold; 2. Patients with type 1 or type 2 diabetes mellitus who have secondary peripheral neuralgia symptoms of diabetes for more than 3 months; 3. Before screening, patients who take orally hypoglycemic drugs and / or insulin must be used stably for 30 days; 4. Subjects who did not use or stably used the oral analgesic drugs for diabetic neuropathy within 7 days before using the test drug; 5. The subjects fully understand the purpose, nature, method and possible adverse reactions of the test, voluntarily participate in the test and sign the informed consent; 6. The subjects can communicate well with the researchers, comply with the requirements of the researchers, and complete the research according to the research regulations; 7. Body mass index (BMI) was = 4 (see attachment 2 for scoring method); 9. HbA1c <= 11%.
Exclusion criteria
Exclusion criteria: 1. Patients with allergy to YJ001, ingredients such as YJ001, placebo, aspirin, salicylic acid or YJ001, such as 5- amino salicylic acid, sulfasalazine and salicylate. 2. Patients who have been exposed to yj001 in any way; 3. The subjects with severe peripheral vascular diseases (such as intermittent claudication, etc.) were not suitable for the study according to the judgment of the researchers; 4. Patients with serious cardiovascular and cerebrovascular diseases (such as serious arrhythmia, heart failure, myocardial infarction, unstable angina, cerebral atherosclerosis, stroke and stroke sequelae, etc.), serious gastrointestinal diseases or other serious diseases (such as cancer, etc.) judged by the researchers are not suitable for the trial; 5. Patients with depression; obvious neurological and mental disorders unrelated to neuropathic pain that may interfere with pain assessment; and other severe pain that may interfere with neuropathic pain assessment; 6. Patients with history of hypoglycemia with clinical symptoms; 7. Subjects who have participated in clinical trials of other drugs or medical devices within one month before screening; 8. Those who donate / lose 400 ml or more blood or those who receive blood transfusion / blood products within 3 months before screening; 9. The subjects who smoked more than 5 cigarettes per day in the three months before screening, or could not stop using any tobacco products during the test period; 10. Subjects whose weekly alcohol consumption is more than 14 units (1 unit alcohol ˜ 360 ml beer or 45 ml spirits with 40% alcohol content or 150 ml wine) in the three months before screening, or who cannot be banned during the test; 11. Patients who have systematically or locally used NSAIDs (NSAIDs, such as ibuprofen, aspirin, salicylic acid, etc.) and salicylic acid drugs (such as 5-aminosalicylic acid, sulfasalazine, salicylate, etc.) within 7 days before using the test drug; 12. Subjects who had used local analgesic drugs (such as capsaicin patch, lidocaine patch, etc.) to treat diabetic neuropathy in the foot within 7 days before using the test drug; 13. Patients with acute or major diseases within one month before screening; 14. Patients who plan to have in-patient surgery or hospitalization during the trial; 15. Patients with previous difficulty in drawing blood; 16. Subjects who are unwilling to stay in the research center and eat according to the prescribed dietary standards during the clinical trial according to the research regulations; 17. Skin redness, inflammation, breakage or other conditions affecting drug absorption at the foot administration site during screening, or according to the judgment of the researcher, the subject has skin diseases, tattoos or other skin abnormalities that may interfere with the purpose of the study; 18. Subjects with abnormal blood pressure and blood lipid (blood pressure >= 150 mmHg / 95 mmHg; total cholesterol >= 6.2 mmol / L and / or triglyceride >= 3.4 mmol / L) that were not controlled or poorly treated at the time of screening; 19. The score of local part of feet is more than 2 points (see Annex 3 for the scoring method); 20. In the subjects with abnormal renal function, the serum creatinine (SCR) was more than 1.5 times of the upper limit of normal; 21. Liver enzymes (ALT and AST) were more than 2 times of the upper limit of normal; 22. Patients with hepatitis B and / or C and / or syphilis and / or human immunodeficiency virus (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digital pain intensity scale;Laboratory examination;Adverse events;Blood concentration of YJ001; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep disturbance score;Multidimensional pain scale; | — |
Countries
China
Contacts
Public ContactZhiguang Zhou
Xiangya Second Hospital of Central South University
Outcome results
None listed