A RANDOMISED CONTROLLED TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES

Not Applicable

Completed

Conditions: Paralytic syndrome, unspecified, SPASTICITY IN ACQUIRED SPINAL CORD INJURIES,

Registration Number: CTRI/2014/10/005150

Lead Sponsor: GOVERNMENT MEDICAL COLLEGEKOZHIKODE

Brief Summary: This study is a randomised controlled comparative open label trial on the safety and efficacy of baclofen 5mg tds with that of diazepam 5mg tds in spasticity due to spinal cord injuries conducted at government medical college ,kozhikode. The primary outcome measure of the study is improvement in spasticity as assessed by functional independence measure ;the adverse drug reaction is also monitored during the study period

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Written informed consent 2.Age 18 years and above 3.Patients after two months of spinal cord injury with established spasticity and not in spinal shock 4.Spasticity due to spinal cord injury of all grades 5.Spasticity interfering with sleep and functional capacity.

Exclusion Criteria

1.Significant history of Hypersensitivity to the study drugs 2.Respiratory disorders like COPD, Sleep apnoea 3.Chronic liver disease 4.Renal disease 5.With psychiatric illness of any kind 6.Broken skin and any infections trigerring spasticity 7.Patients receiving drugs interfering significantly with the study drugs 8.Patients planned for surgical intervention 9.Glaucoma 10.Myasthenia gravis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IMPROVEMENT IN SPASTICITY AS OBTAINED BY IMPROVEMENT IN FUNCTIONAL INDEPENDENCE MEASURE SCORE;MONITORING ADVERSE DRUG REACTION DURING STUDY PERIOD	DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90

Secondary Outcome Measures

Name	Time	Method
TO COMPARE THE ADVERSE DRUG PROFILE OF BACLOFEN WITH THAT OF DIAZEPAM	DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90

Trial Locations

Locations (1): GOVERNMENT MEDICAL COLLEGE,KOZHIKODE
🇮🇳
Kozhikode, KERALA, India
GOVERNMENT MEDICAL COLLEGE,KOZHIKODE
🇮🇳Kozhikode, KERALA, India
Dr HEMALATHA T
Principal investigator
9746615918
hemalini11@gmail.com