Diabetic Peripheral Neuropathy
Conditions
Interventions
Control group:Placebo
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Type 1 or type 2 diabetic peripheral neuropathy; 2. Aged 18-70 years old; 3. HbA1c<11%; 4. Responded poorly to conventional treatments for at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Had a continuous antibiotic use history for >3 days within 3 months prior to enrolment; 2. Had any clinically significant or unstable mental or psychiatric illnesses or epilepsy; 3. Had other causes of neuropathy, such as osteoarthritis, cervical lumbar diseases, connective tissue disease, peripheral vascular disease, tumor peripheral neuropathy, herpes zoster infection, abnormal thyroid function, or severe malnutrition; 4. Had undergone gastrectomy, fundoplication, colostomy or other digestive system surgery; 5. Had persistent vomiting or a suspected gastrointestinal obstruction; 6. Had taken drugs that can cause peripheral neuropathy, such as isoniazid or furazolidone; 7. Had severe cardiovascular and cerebrovascular diseases or liver, kidney and haematopoietic system diseases; 8. Had alcoholism (drinking more than 5 times in one week, more than 100 g of spirits, 250 g of rice wine or 5 bottles of beer); 9. Were pregnant; 10.Had a physical disability or self-care disability or were unable to recall clearly and answer questions due to any other reasons; 11.Lacked the time to take part in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Toronto Clinical Scoring System score at 84 Days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in VAS score at 84 Days;Change from baseline in Hamilton Anxiety Scale score at 84 Days;Change from baseline in Hamilton Depression Scale score at 84 Days;Change from baseline in Pittsburgh Sleep Quality Index score at 84 Days;Change from baseline in the Brief table of the World Health Organization’s Quality of Life score at 84 Days;Change from baseline in Peripheral nerve conduction velocity at 84 Days;Change from baseline in current perception threshold at 84 Days; | — |
Countries
China
Contacts
Public ContactYuan Huijuan
Henan Provincial People's Hospital
Outcome results
None listed