Effect of melatonin supplement versus placebo on the severity of pain, sleep disorder, and quality of life in patients with painful diabetic neuropathy
Phase 2
Recruiting
- Conditions
- Painful diabetic neuropathy.Type 2 diabetes mellitus with diabetic neuropathy, unspecifiedE11.40
- Registration Number
- IRCT20120215009014N299
- Lead Sponsor
- Hamedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 116
Inclusion Criteria
Age of 18 to 70 years,
Type 2 diabetes for at least one year,
Painful neuropathy
Exclusion Criteria
Pregnancy or breastfeeding,
Foot ulcer of infection,
Hemoglobin A1c =9,
Cerebrovascular Diseases and discopathy,
Using anti-inflammatory and analgesic drugs,
Drinking alcohol or using opioid substances
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean score of pain. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using Visual Analog Scale (VAS).;Mean score of sleep disorder. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using standard questionnaire.;Mean score of Clinical Global Impression of Change (CGIC). Timepoint: Before the intervention and at the eighth week after the intervention. Method of measurement: Using the standard questionnaire.
- Secondary Outcome Measures
Name Time Method Mean score of quality of life. Timepoint: Before the intervention and at the eighth week after the intervention. Method of measurement: Using the SF-36 questionnaire.