Diabetic painful peripheral neuropathy. Autonomic neuropathy in endocrine and metabolic diseases
Conditions
Interventions
Placebo
Intervention 1: Gabapentin capsules 100 mg on the 1st day, 200 mg on the 2nd day, and 300 mg on the 3rd day plus topical moisturizing capsaicin cream 3 times a day, the size of a finger on the painful
Treatment - Drugs
Gabapentin capsules 100 mg on the 1st day, 200 mg on the 2nd day, and 300 mg on the 3rd day plus topical moisturizing capsaicin cream 3 times a day, the size of a finger on the painful area.
Placebo (a capsule containing starch) plus topical moisturizing capsaicin cream 3 times a day, the size of a finger on the painful area.
Sponsors
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants including major eligibility criteria as follows: Inclusion criteria: (a) having painful diabetic neuropathy; (b) age of 18 to 65 years. Exclusion criteria: (a) a history of cardiac arrhythmias, valvular heart disease, heart block, symptomatic ischemic heart disease; (b) open-heart surgery; (c) a history of using anti-arrhythmic drugs, beta-blockers, tricyclic antidepressants, or phenothiazines; (d) pregnancy and lactation; (e) history of major depression; (f) ESRD; (g) history of allergy to gabapentin or capsaicin; (c) unstable general status.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard Deviation NN (SDNN). Timepoint: For 3 days. Method of measurement: 24-hour holter monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ortostatic hypotansion in the standing position. Timepoint: For 3 days. Method of measurement: mercury sphygmomanometer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Maryam Vasheghani
Shahid Beheshti Hospital
Outcome results
None listed