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Conditions
Interventions
plai balm 15%w/w apply 3 times/day and received gabapentin 300 mg once a day before bedtime ,placebo balm apply 3 times/day and received gabapentin 300 mg once a day before bedtime
Active Comparator Drug,Placebo Comparator Drug
plai balm 15%w/w ,placebo balm
Sponsors
none
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Criteria included aged of 20-60 years who has been diagnosed with diabetic mellitus for 1 year at least, and had been tested for HbA1c within 6 months, patients who had suffered from pain intensity on scale as moderate (Numerical rating scale (NRS), Pain score ≥ 4), the defined positive monofilament score result.
Exclusion criteria
Exclusion criteria: Patient who has been diagnosed with diabetic mellitus less than one year, with other caused neuropathy, clinically significant cardiovascular, foot ulcer or/and infection, pregnancy and lactation, and allergic of Plai, were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the mean change of pain scores 2 weeks numerical rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% reduction of pain 4 weeks numerical rating scale | — |
Countries
Thailand
Contacts
Public ContactNACHAPOL JATUTEN
selaphum hospital
Outcome results
None listed