Health Condition 1: G620- Drug-induced polyneuropathy Health Condition 2: G600- Hereditary motor and sensory neuropathy Health Condition 3: G619- Inflammatory polyneuropathy, unspecified Health Condition 4: G64- Other disorders of peripheral nervous system Health Condition 5: G629- Polyneuropathy, unspecified Health Condition 6: G651- Sequelae of other inflammatory polyneuropathy
Conditions
Interventions
Intervention1: Amitriptyline, Gabapentin, Pregabalin, Duloxetine: Amitriptyline 10mg orally at bed time for 8 weeks,
Gabapentin 300mg orally at bed time for 8 weeks,
Pregabalin 150mg orally at bed t
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
Eligibility
Inclusion criteria
Inclusion criteria: Age more than sixty years of either sex 1. Patients newly diagnosed as a case of peripheral neuropathy according to Modified Toronto Clinical Neuropathy (score > 11) or known case of peripheral neuropathy without any treatment for past 8 weeks 2. Patient willing to participate in the study by giving Informed consent
Exclusion criteria
Exclusion criteria: 1. Age 2. Declined consent. 3. Acute serious illness (like Myocardial Infarction, Stroke, Sepsis, Electrolyte disturbances) 4. Known case of any malignancy 5. H/o alcohol consumption ( >100 gm/day) for more than three years 6. Patients with score of 11 in modified Toronto Clinical Neuropathy Score 7. Serum Aminotransferase (ALT) > 3 times of upper limit of normal level 8. Chronic Kidney disease or Estimated Glomerular Filtration Rate (eGFR) ml/min/1.73m2 9. Patients with documented or clinical features of Vitamin B12 deficiency 10. H/o raised intra-ocular pressure / acute angle closure glaucoma 11. H/o any major psychiatric disorders 12. H/o treatment with Monoamine Oxidase Inhibitors in past 14 days 13. History suggestive of lower urinary tract symptoms or Benign prostatic hyperplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients showing 50% reduction in the modified Toronto Clinical Neuropathy Score from baseline to 8 weeks 2. Mean change in modified Toronto Clinical Neuropathy Score from baseline to 8 weeks Timepoint: First Visit (Baseline, 0 weeks) Second Visit (8th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in Verbal Rating Scale, Global Depression Score â?? shorter version, The Lawtonâ??s Instrumental Activities of Daily Living Score from baseline to 8 weeks. 2. Recording of adverse event, if any, according to the prescribed proforma issued by Pharmacovigilance program of India (PvPI). Casualty assessment will be done using Naranjo Probability Scale and severity assessment will be done using Hartwigâ??s scale.Timepoint: First Visit (Baseline, 0 weeks) Second Visit (8th week) | — |
Countries
India
Contacts
Public ContactMahesh Kumar B
All India Institute of Medical Sciences, Raipur
Outcome results
None listed