The study to compare Amitriptyline and Mirtazapine in patient of peripheral diabetic neuropathic pai

Phase 4

• Conditions: Health Condition 1: null- Peripheral Diabetic Neuropathic Pain

• Registration Number: CTRI/2013/08/003893
• Lead Sponsor: Dr Kaksha Patel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified