Comparative efficacy of Duloxetine versus Gabapantin in patients with painful diabetic peripheral neuropathy
Phase 3
- Conditions
- painful diabetic peripheral neuropathy.Diabetic polyneuropathy
- Registration Number
- IRCT20161023030455N2
- Lead Sponsor
- Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences Department of Neuro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
aged>18
rule out other DDx. for peripheral neuropathy
do nt use drug for treatment of DPNP
duration of diabetes ranging from 1 to 15 years
HbA1C less than 10 mg
A pain score of at least 40 mm on the 100 mm visual analogue scale (VAS)
Exclusion Criteria
patients who were already on other medication for the treatment of DPNP one week prior to the study enrolment
hepatic failure;
;renal failure with GFR<30 ml/min
concurernt of psycologic disoeder
cardiac arhythmia
patients with established neuropathy due to other causes;,
history of epilepsy
drug abuse
uncontoroled acute close angle Glocoma
recent MI
patients who did not give written informed consent
pregnant or lactating women
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain. Timepoint: Before treatment and 1,4 and 8 weeks after treatment. Method of measurement: visual analogue scale.
- Secondary Outcome Measures
Name Time Method Sleep quality. Timepoint: Before treatment and 1,4 and 8 weeks after treatment. Method of measurement: Sleep interference score.;Changes in clinical status. Timepoint: 1,4and 8 weeks after treatment. Method of measurement: Clinical Global Impression of Change.