Study of effect of olive leaves on diabetic neuropathy
- Conditions
- Diabetic neuropathy.Diabetic autonomic neuropathyE10.4
- Registration Number
- IRCT20100513003922N4
- Lead Sponsor
- Kermanshah University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Type I and II diabetic patients who have diabetes for at least one year and have diabetic neuropathy pain
History of neuropathic pain for at least three months
a pain score (VSA) equal to or greater than 4
at least 18 years of age or older
HbA1c is equal to or less than 11
Pregnant and lactating women
ischemic pain or other pain such as pains associated with amputation or arthritis
Electroconvulsive Therapy in the past 30 days
using warfarin, antiarrhythmic drugs, sedatives, hypnotices, anticonvulsants, NSAIDs and capsaicin in the past 7 days
using antipsychotics, antidepressants, opioids and muscle relaxants during the past 14 days
using anti-neuropathic drug and Unwillingness to stop taking it
Dependence on alcohol or other drugs
important metabolic diseases, cardiovascular diseases, thyroid disease, major blood diseases, reduced kidney function or liver function, bipolar disease, psychosis
history of suicide
drug sensitivity
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain score on visual analog scale. Timepoint: At the end of each month for three consecutive months. Method of measurement: visual analog scale.
- Secondary Outcome Measures
Name Time Method Quality of life score. Timepoint: At the beginning of the study and at the end of the third month of the study. Method of measurement: Quality of life questionnaire SF-36.;Diarrhea. Timepoint: during the study. Method of measurement: questionnaire of patient-reported side effects.;Stomach ache. Timepoint: during the study. Method of measurement: questionnaire of patient-reported side effects.