Diabetic Peripheral Neuropathy
Conditions
Interventions
Experimental group:Baimai Ointment
Control group:Baimai Ointment simulator (placebo)
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 30-65 years (inclusive of 30 and 65), no gender restriction; 2. Meet the Western medicine diagnostic criteria for diabetic peripheral neuropathy, and the duration of diabetes is >= 6 months; 3. Electromyography shows at least 2 nerves with slowed conduction velocity; 4. Participants are informed and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to the drugs and excipients used in the study, or those allergic to multiple (two or more) drugs; 2. Individuals with a Michigan Neuropathy Screening Instrument (MNSI) score 8%; 5. Individuals with an ankle-brachial index (ABI) <0.9; 6. Individuals who are intolerant to hot water or heat-based drugs at the lesion site, or intolerant to massage or local physical stimulation; 7. Diabetic foot patients with skin rashes or ulceration on the lower limbs; 8. Individuals with significant clinical or unstable diseases, such as but not limited to severe cardiovascular or cerebrovascular diseases, hematopoietic system disorders, and malignant tumors, and determined by the investigator to interfere with trial participation; 9. Individuals with an implanted cardiac pacemaker or implantable cardioverter-defibrillator; 10. Individuals with liver or kidney dysfunction, serum creatinine above the upper normal limit, or serum transaminase more than twice the upper normal limit; 11. Individuals whose oral mecobalamin tablet treatment course has been less than 30 days before enrollment; 12. Screen those who have used the following drugs and/or non-drug measures for the treatment of diabetic peripheral neuropathy, other than mecobalamin, within the past month: (1) Neurotrophic drugs: such as inactive vitamin B12, etc.; (2) Antioxidant drugs: such as alpha-lipoic acid, etc.; (3) Aldose reductase inhibitors: such as epalrestat, etc.; (4) Microcirculation improvement drugs: such as prostaglandin E1, alprostadil sodium, pentoxifylline, kallikrein, batroxobin, calcium dobesilate, etc.; (5) Cell energy metabolism improvement drugs: such as acetyl-L-carnitine, etc.; (6) Anticonvulsants: such as pregabalin, gabapentin, carbamazepine, etc.; (7) Serotonin-norepinephrine reuptake inhibitors: such as duloxetine, etc.; (8) Tricyclic antidepressants: such as amitriptyline, etc.; (9) Opioids: such as tapentadol, tramadol, etc.; (10) Topical medications: such as 8% capsaicin patches, etc. (11) Traditional Chinese medicine: Mudan granules, compound Danshen dripping pills, Qidan Tongluo granules, traditional Chinese medicinal decoctions, etc.; (12) Acupuncture, electrical stimulation, moxibustion, acupoint injection, fumigation and washing, physical therapy, etc.; (13) Individuals who have experienced acute complications of diabetes or severe infections within one month prior to screening; (14) Individuals who have participated in other clinical trials within one month prior to screening (except non-interventional studies or those who signed the ICF but did not receive study interventions); (15) Individuals with a history of alcohol abuse within one year prior to screening [defined as regular drinking more than 14 times per week (1 time ˜150 mL wine or 360 mL beer or 45 mL spirits) or abuse/dependence on psychoactive substances]; (16) Pregnant women, women with a positive pregnancy test during the screening period, breastfeeding women, women planning pregnancy or egg donation from the time of signing informed consent until 3 months after the end of the trial, or those unwilling to use effective contraception during this period; (17) Individuals deemed unsuitable for participation in the clinical trial by the investigator, including those judged to have poor compliance, those li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in total score of the Toronto Clinical Scoring System from baseline at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in Michigan Diabetic Peripheral Neuropathy score from baseline at the end of treatment;Changes in TCSS scores before and after treatment;Changes in the severity of TCSS scores before and after treatment;Changes in MDNS scores before and after treatment;Changes in clinical symptom scores from baseline before and after treatment;Changes in motor and sensory nerve conduction tests, F waves, and H reflexes;Changes in the scores of the 36-Item Short Form Health Survey (SF-36) from baseline;Changes in the Visual Analogue Scale (VAS) scores for clinical symptoms from baseline before and after treatment; | — |
Countries
China
Contacts
Public ContactTong Xiaolin
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed