Comparative study in medical management of Neuropathic pain

Phase 4

Completed

• Conditions: Diagnosed by consultant neurologist.Scoring ≥4 at DN4 Neuropathic pain diagnostic questionnaireScoring ≥4 at Numeric pain rating scale at baseline presentation.Age 18-75 yrs.

• Registration Number: CTRI/2016/08/007163
• Lead Sponsor: Dr Sourav Chakrabarty

Brief Summary

An open label, comparative, randomised, prospectivestudy will be conducted regarding the safety & efficacy ofPregabalin,Duloxetine,Amitryptiline &Pregabalin plus Amitryptiline onreducing neuropathic pain,due to various etiology,in patients of age group18-75 yrs, attending Neurology OPD B.S.Medical college.Total duration of studywill be one year(Feb 2015-Jan 2016).Patients will be followed up for 4 weeks..Wewill also assess the therapeutic  safetyin each treatment groups and any associated adverse effects. Simultaneously wewill also assess the quality of improvement of sleep in each treatmentgroups.The key objectives will be to find out the drug with maximum efficacy inreducing neuropathic pain as well as in improving the quality of sleep in thepatients.We will also try to find out the drug with minimum adverse effects intheir respective study groups.The study will proceed after obtaining ethicalclearance from the institutional ethics committee. Before beginning theinterview, informed written consent will be taken from each participant.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-18
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inclusion criteria: (1)Diagnosed by consultant neurologist as having neuropathic pain.
• (2)Scoring ≥4 at DN4 Neuropathic pain diagnostic questionnaire (3)Scoring ≥4 at Numeric pain rating scale at baseline presentation.
• (4)Age group 18-75 yrs.

Exclusion Criteria

• Exclusion criteria: (1)Known serious spinal disease/bony deformity/vertebral fracture (2)Abnormal renal function test.
• (3)Cardiac conduction defect.
• (4)Known allergy to any of the study medication.
• (5)Benign Hyperplasia of prostate or H/O urinary retention.
• (6)Pregnant& lactating mother.
• (7)Patients taking MAO inhibitors.
• (8)Inflammatory/Rheumatologic disorder.
• (9)Suicidal tendency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out the drug with maximum efficacy in reducing neuropathic pain,as measured by Neuropathic pain symptom Inventory score(NPSI)in a treatment group.	4 weeks

Secondary Outcome Measures

Name	Time	Method
To find out the drug which causes maximum improvement of Quality of sleep as measured by The Pittsburgh Sleep Quality Index (PSQI)score.	4 weeks
Comparison of incidence of adverse drug reaction in each treatment groups.

Trial Locations

Locations (1)

Bankura sammilani medical college; 🇮🇳 Bankura, WEST BENGAL, India

Bankura sammilani medical college

🇮🇳Bankura, WEST BENGAL, India

Dr Sourav Chakrabarty

Principal investigator

7602580581

dr.souravchakraborty87@gmail.com