A clinical trial to study and compare the effects of two drugs amitriptyline and duloxetine in patients with type 2 diabetes mellitus with neuropathic pai
- Conditions
- Health Condition 1: null- PAINFUL DIABETIC NEUROPATHY
- Registration Number
- CTRI/2010/091/001036
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion criteria
1. Presence of type 2 diabetes mellitus
2. No change in anti-diabetic medication for the last 1 month
3. Evidence of diabetic neuropathy by Diabetic Neuropathy
Symptom Score >1 point, Diabetic Neuropathy Examination Score
>4 point, Vibration perception test and monofilament test.
4. Neuropathic pain present for at least 1 month
5. Mean pain intensity of more than 50% by patient assessment by
VAS
Exclusion criteria
1. Age below 18 or above 75 years
2. Evidence of renal disease (Se. creatinine > 1.5)
3. Evidence of liver disease (deranged LFT with clinical evidence)
4. Pregnant and lactating mothers and women intending pregnancy
5. Evidence of other causes for neuropathy and painful conditions
6. Epilepsy, psychiatric and cardiac diseases, hypertensives not on
treatment,
peripheral vascular disease and substance abuse.
7. Intake of anticonvulsants, antidepressants, membrane
stabilizers and opioids
8. Participation in any other clinical trial with in the last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients showing improvement by patient assessment of efficacy by visual analogue scale was done. This was compared between the two treatment groups.Timepoint: Baseline (0), 2,4 6 weeks
- Secondary Outcome Measures
Name Time Method Comparison of the following scores between patients for painful diabetic neuropathy- <br/ ><br>1. Short form McGill pain questionnaire <br/ ><br>2.11- point Likert scale for pain <br/ ><br>3.Hamilton rating scale for depression <br/ ><br>4.Adverse events <br/ ><br>5.Quality of night time sleep <br/ ><br>6.Patient preference of the drug <br/ ><br>7.Patient Global Impression of Change (PGIC, 7-point scale). <br/ ><br>Timepoint: baseline,2 4 6 weeks