Patients with diabetic neuropathic pain diabetic neuropathic pain
Conditions
Interventions
Apply and massage to the feet on the painful area (feet only) twice a day (morning and evening) after showering. Use 2 grams of the medication per application (approximately the size of the right inde
Experimental Drug,Placebo Comparator Drug
Painplai,Placebo
Sponsors
Faculty Pharmaceutical sciences, Khon Kaen University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diabetic patients aged 20 years and over 2. Patients with neuropathic pain on the feet (DN-4 is greater than or equal to 4 points, and ID pain is greater than or equal to 2 points) 3. Patients with a baseline pain score measured by NRS of at least 4 points 4. Patients with chronic pain for more than 3 months 5. Not taking any other pain medication except gabapentin, amitriptyline, nortriptyline, and tramadol 6. Informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with pain from peripheral neuropathy in the hands or other areas besides the feet 2. Have a history of foot surgery or foot wounds 3. Have taken pain medication or herbal remedies to relieve pain within 3 days before participating in the research 4. Patients with schizophrenia 5. Patients who are taking carbamazepine, fluoxetine, or sertraline 6. Have a history of allergy to Zingiber cassumunar, turmeric, other ingredients in Painplai, or gabapentin, amitriptyline, nortriptyline, and tramadol 7. Patients with impaired verbal or reading comprehension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of median NRS (within group) week 2 and week 4 NRS score/NRS scale,change of median NRS (between group) week 2 and week 4 NRS score/NRS scale,change of median ID pain (within group) week 2 and week 4 ID pain score/ID pain questionaire,change of median ID pain (between group) week 2 and week 4 ID pain score/ID pain questionaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with NRS reduction is greater than 30% week 2 and week 4 NRS score/NRS scale,Number of patients who received ADRs from medication week 2 and week 4 amount/counting method,The relationship between mean HbA1c, FBS and mean NRS score before starting topical pain medication baseline mean HbA1c/mean FBS/mean NRS/Statistical Analysis | — |
Countries
Thailand
Contacts
Public ContactNatthida Kaewpetch
Chatturat Hospital
Outcome results
None listed