Evaluation of effectiveness and safety of first line drugs used in the treatment ofperipheral neuropathy for older individuals

Phase 4

Conditions: Health Condition 1: G620- Drug-induced polyneuropathyHealth Condition 2: G600- Hereditary motor and sensory neuropathyHealth Condition 3: G619- Inflammatory polyneuropathy, unspecifiedHealth Condition 4: G64- Other disorders of peripheral nervous systemHealth Condition 5: G629- Polyneuropathy, unspecifiedHealth Condition 6: G651- Sequelae of other inflammatory polyneuropathy

Recruitment & Eligibility

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

1. Age < 60years

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) < 45

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

Primary Outcome Measures

Name	Time	Method
1. Proportion of patients showing 50% reduction in the modified Toronto Clinical <br/ ><br>Neuropathy Score from baseline to 8 weeks <br/ ><br> <br/ ><br>2. Mean change in modified Toronto Clinical Neuropathy Score from baseline to 8 weeks <br/ ><br>Timepoint: First Visit (Baseline, 0 weeks) <br/ ><br>Second Visit (8th week)

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>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) <br/ ><br>Second Visit (8th week)