Effect of L arginine, vit B6, B12 and vit D for neurological recovery in acute spinal cord injury (ASCI) subjects
Phase 3
- Conditions
- Health Condition 1: G958- Other specified diseases of spinalcord
- Registration Number
- CTRI/2020/03/024016
- Lead Sponsor
- Dr R N Srivastava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
2.ASCI less than 6 weeks of injury
3.Motor complete thoracolumbar injury (AIS A, B),
4.TLISS greater than or equal to 4 requiring surgical stabilization
5.Hypovitaminosis D: 25(OH) D levels less than 30ng/ml
Exclusion Criteria
1.Other associated injuries such as major thoracoabdominal injuries & head injuries needing intervention.
2.Neuro-psychiatric patients and patients on steroid or other immunosuppressant therapy or other comorbid conditions making subjects unfit for surgery
3.Subjects who do not give consent for participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Assessment- <br/ ><br> <br/ ><br>Neurological status- at baseline, at 3rd week 3rd and 6 months <br/ ><br> <br/ ><br>Nutrition status- at baseline at 3rd week 3rd and 6 monthsTimepoint: At baseline at 3rd week 3rd and 6 months
- Secondary Outcome Measures
Name Time Method Quality of life (QoL) Assessment: <br/ ><br>Spinal Cord Independence Measure (SCIM) questionnaire will be used; At baseline, 3rd week, 3rd and 6 months. <br/ ><br>Metabolites status: <br/ ><br>Glycine and succinate profiling of serum bio-fluid in acute spinal cord injury in order to elucidate their possible role as prognostic indicator of neurological recovery.Timepoint: At baseline, at 3rd week, 3rd and 6 months.