Health Condition 1: null- Peripheral Diabetic Neuropathic Pain
Conditions
Interventions
Intervention1: Mirtazapine: 15 30 45 mg OD (once daily) for 6 weeks (according to response of the patient.It will be given orally as a tablet
Control Intervention1: Amitriptyline: 10 25 50 mg OD(once
Sponsors
Dr Kaksha Patel
Eligibility
Inclusion criteria
Inclusion criteria: Rating of greater than or equal to 4 on Brief Pain Inventory (BPI) 24 hour average pain item Daily pain for greater than 3 months before entry into study Stable glycemic control (HbA1c less than or equal to 7) Score of atleast greater than or equal to 3 in section B of Michigan Neuropathy Screening Instrument Patient either of Diabetes 1 or 2 Ability to give written informed consent
Exclusion criteria
Exclusion criteria: Risk of suicide as judged by investigator by score greater than or equal to 2 on suicide parameter of Hamilton depression score Disorder like mania, bipolar disorder, and psychosis Patient with renal dysfunction (serum creatinine greater than 1.2 mg/dl) Patient with Vitamin B12 level less than 200ng/L Clinically significant cardiovascular, respiratory ,central nervous system, endocrinal or dermatological disorder Patient with symptomatic or history of peripheral vascular disease Patient with history of alcohol intake Patient with allergic reaction to test drug Patient with neoplastic disease History of substance abuse Patient with uncontrolled hypertension Patients who were unable to continue for the proposed length of treatment or return for follow-up visits. Pregnant or lactating women Apparently unresponsive to test drug Patient with HIV neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare efficacy and safety of mirtazapine and amitriptyline in patient of peripheral diabetic neuropathic pain in term of BPI score. Timepoint: screening day 0 week 2 week 4 week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare efficacy and safety of mirtazapine and amitriptyline in patients of peripheral diabetic neuropathic pain in term of Hamilton depression scoreTimepoint: screening day 0 week 2 week 4 week 6;To compare efficacy and safety of mirtazapine and amitriptyline in patients of peripheral diabetic neuropathic pain in term of Michigan neuropathy screening instrumentTimepoint: screening day 0 week 2 week 4 week 6 | — |
Countries
India
Contacts
Public ContactDr Kaksha Patel
Government Medical College Bhavnagar
Outcome results
None listed